Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-30 @ 5:25 AM
Study NCT ID:
NCT00422461
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2007-01-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619499', 'term': 'PF-00489791'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)', 'description': 'Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who took at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 12, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 11, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 11, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 13, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Mucous stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Conjunctivitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Viral labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'White blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Libido increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Erection increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Spontaneous penile erection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}], 'seriousEvents': [{'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '-3.28', 'spread': '1.08', 'groupId': 'OG002'}, {'value': '-5.59', 'spread': '1.54', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0822', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.80', 'ciLowerLimit': '-5.97', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.60', 'statisticalMethod': 'Nonlinear dose response regression model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0170', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.66', 'ciLowerLimit': '-8.47', 'ciUpperLimit': '-0.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.92', 'statisticalMethod': 'Nonlinear dose response regression model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0026', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.97', 'ciLowerLimit': '-11.45', 'ciUpperLimit': '-2.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.26', 'statisticalMethod': 'Nonlinear dose response regression model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28', 'description': 'The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean daytime SBP was an average of SBP measurements taken between 08:00 and 16:00 hours by ABPM device on the specified time points. In this outcome measure change from baseline in mean daytime SBP at Day 28 is reported.', 'unitOfMeasure': 'millimeter of mercury', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) as Measured by ABPM at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-1.97', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '-3.83', 'spread': '0.78', 'groupId': 'OG002'}, {'value': '-6.23', 'spread': '1.09', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.70', 'ciLowerLimit': '-5.09', 'ciUpperLimit': '-0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.20', 'statisticalMethod': 'Nonlinear dose response regression model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.56', 'ciLowerLimit': '-7.35', 'ciUpperLimit': '-1.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.41', 'statisticalMethod': 'Nonlinear dose response regression model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.96', 'ciLowerLimit': '-10.03', 'ciUpperLimit': '-3.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.55', 'statisticalMethod': 'Nonlinear dose response regression model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28', 'description': 'The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean daytime DBP was an average of DBP measurements taken between 08:00 and 16:00 hours by ABPM device on the specified time points. In this outcome measure change from baseline in mean daytime DBP at Day 28 is reported.', 'unitOfMeasure': 'millimeter of mercury', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean 24-Hour SBP and DBP as Measured by ABPM at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'title': 'SBP', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '1.47', 'groupId': 'OG001'}, {'value': '-5.28', 'spread': '1.55', 'groupId': 'OG002'}, {'value': '-3.96', 'spread': '1.57', 'groupId': 'OG003'}]}]}, {'title': 'DBP', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '-3.94', 'spread': '1.09', 'groupId': 'OG002'}, {'value': '-4.09', 'spread': '1.09', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9479', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-3.79', 'ciUpperLimit': '4.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.98', 'groupDescription': 'For SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0215', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.75', 'ciLowerLimit': '-8.78', 'ciUpperLimit': '-0.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.03', 'groupDescription': 'For SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0886', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.43', 'ciLowerLimit': '-7.39', 'ciUpperLimit': '0.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.00', 'groupDescription': 'For SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3173', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.45', 'ciLowerLimit': '-4.30', 'ciUpperLimit': '1.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.44', 'groupDescription': 'For DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0087', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.81', 'ciLowerLimit': '-6.64', 'ciUpperLimit': '-0.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.42', 'groupDescription': 'For DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0062', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.95', 'ciLowerLimit': '-6.76', 'ciUpperLimit': '-1.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.41', 'groupDescription': 'For DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28', 'description': 'The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean 24-hour SBP and DBP was an average of SBP and DBP measurements, respectively, taken for 24 hours by ABPM device respectively. In this outcome measure change from baseline in mean 24-hour SBP and DBP at Day 28 is reported.', 'unitOfMeasure': 'millimeter of mercury', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Minimum and Maximum SBP and DBP as Measured by ABPM Over 24 Hours on Baseline, Day 1, 14 and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'title': 'Maximum SBP: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '176.65', 'spread': '12.38', 'groupId': 'OG000'}, {'value': '179.68', 'spread': '12.40', 'groupId': 'OG001'}, {'value': '184.58', 'spread': '15.30', 'groupId': 'OG002'}, {'value': '177.45', 'spread': '15.42', 'groupId': 'OG003'}]}]}, {'title': 'Maximum SBP: Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '173.13', 'spread': '12.21', 'groupId': 'OG000'}, {'value': '176.67', 'spread': '19.60', 'groupId': 'OG001'}, {'value': '175.62', 'spread': '12.29', 'groupId': 'OG002'}, {'value': '168.00', 'spread': '12.17', 'groupId': 'OG003'}]}]}, {'title': 'Maximum SBP: Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '177.58', 'spread': '14.53', 'groupId': 'OG000'}, {'value': '177.90', 'spread': '21.59', 'groupId': 'OG001'}, {'value': '179.60', 'spread': '11.75', 'groupId': 'OG002'}, {'value': '176.52', 'spread': '16.68', 'groupId': 'OG003'}]}]}, {'title': 'Maximum SBP: Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '177.33', 'spread': '14.54', 'groupId': 'OG000'}, {'value': '180.40', 'spread': '19.40', 'groupId': 'OG001'}, {'value': '177.04', 'spread': '14.29', 'groupId': 'OG002'}, {'value': '174.69', 'spread': '12.14', 'groupId': 'OG003'}]}]}, {'title': 'Minimum SBP: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '117.88', 'spread': '11.79', 'groupId': 'OG000'}, {'value': '114.38', 'spread': '12.65', 'groupId': 'OG001'}, {'value': '122.52', 'spread': '11.66', 'groupId': 'OG002'}, {'value': '115.30', 'spread': '13.60', 'groupId': 'OG003'}]}]}, {'title': 'Minimum SBP: Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '119.06', 'spread': '12.32', 'groupId': 'OG000'}, {'value': '110.27', 'spread': '14.38', 'groupId': 'OG001'}, {'value': '110.21', 'spread': '13.46', 'groupId': 'OG002'}, {'value': '109.38', 'spread': '13.30', 'groupId': 'OG003'}]}]}, {'title': 'Minimum SBP: Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '113.82', 'spread': '12.76', 'groupId': 'OG000'}, {'value': '114.31', 'spread': '13.59', 'groupId': 'OG001'}, {'value': '114.07', 'spread': '11.99', 'groupId': 'OG002'}, {'value': '111.94', 'spread': '10.52', 'groupId': 'OG003'}]}]}, {'title': 'Minimum SBP: Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '117.57', 'spread': '15.54', 'groupId': 'OG000'}, {'value': '114.27', 'spread': '13.66', 'groupId': 'OG001'}, {'value': '116.64', 'spread': '10.28', 'groupId': 'OG002'}, {'value': '110.34', 'spread': '8.32', 'groupId': 'OG003'}]}]}, {'title': 'Maximum DBP: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '116.21', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '114.53', 'spread': '10.53', 'groupId': 'OG001'}, {'value': '116.81', 'spread': '11.97', 'groupId': 'OG002'}, {'value': '116.76', 'spread': '9.86', 'groupId': 'OG003'}]}]}, {'title': 'Maximum DBP: Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '113.81', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '110.58', 'spread': '10.29', 'groupId': 'OG001'}, {'value': '111.38', 'spread': '9.63', 'groupId': 'OG002'}, {'value': '109.41', 'spread': '11.16', 'groupId': 'OG003'}]}]}, {'title': 'Maximum DBP: Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '115.03', 'spread': '9.17', 'groupId': 'OG000'}, {'value': '111.97', 'spread': '10.61', 'groupId': 'OG001'}, {'value': '111.97', 'spread': '10.35', 'groupId': 'OG002'}, {'value': '111.58', 'spread': '10.09', 'groupId': 'OG003'}]}]}, {'title': 'Maximum DBP: Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '117.20', 'spread': '11.86', 'groupId': 'OG000'}, {'value': '113.10', 'spread': '9.42', 'groupId': 'OG001'}, {'value': '112.32', 'spread': '11.76', 'groupId': 'OG002'}, {'value': '111.97', 'spread': '10.58', 'groupId': 'OG003'}]}]}, {'title': 'Minimum DBP: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '68.15', 'spread': '9.08', 'groupId': 'OG000'}, {'value': '63.50', 'spread': '8.31', 'groupId': 'OG001'}, {'value': '67.90', 'spread': '9.01', 'groupId': 'OG002'}, {'value': '65.18', 'spread': '8.11', 'groupId': 'OG003'}]}]}, {'title': 'Minimum DBP: Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.69', 'spread': '9.30', 'groupId': 'OG000'}, {'value': '60.67', 'spread': '8.86', 'groupId': 'OG001'}, {'value': '59.34', 'spread': '8.52', 'groupId': 'OG002'}, {'value': '60.16', 'spread': '8.60', 'groupId': 'OG003'}]}]}, {'title': 'Minimum DBP: Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '65.48', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '62.07', 'spread': '9.51', 'groupId': 'OG001'}, {'value': '61.13', 'spread': '9.75', 'groupId': 'OG002'}, {'value': '62.45', 'spread': '8.20', 'groupId': 'OG003'}]}]}, {'title': 'Minimum DBP: Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '65.93', 'spread': '11.58', 'groupId': 'OG000'}, {'value': '62.23', 'spread': '7.78', 'groupId': 'OG001'}, {'value': '64.11', 'spread': '8.71', 'groupId': 'OG002'}, {'value': '61.38', 'spread': '8.42', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug), Day 1, 14 and 28', 'description': 'The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed on Baseline, Day 1, 14 and 28. In this outcome measure maximum and minimum SBP and DBP values recorded by ABPM device over 24 hours on Baseline, Day 1, 14 and 28 are reported.', 'unitOfMeasure': 'millimeter of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cuff SBP and DBP at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'title': 'Cuff SBP', 'categories': [{'measurements': [{'value': '-4.60', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '-5.20', 'spread': '1.82', 'groupId': 'OG001'}, {'value': '-4.97', 'spread': '1.89', 'groupId': 'OG002'}, {'value': '-9.76', 'spread': '1.95', 'groupId': 'OG003'}]}]}, {'title': 'Cuff DBP', 'categories': [{'measurements': [{'value': '-1.33', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-4.37', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '-5.82', 'spread': '1.27', 'groupId': 'OG002'}, {'value': '-5.63', 'spread': '1.30', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-5.51', 'ciUpperLimit': '4.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.48', 'groupDescription': 'For cuff SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8809', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-5.21', 'ciUpperLimit': '4.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.44', 'groupDescription': 'For cuff SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0382', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.16', 'ciLowerLimit': '-10.04', 'ciUpperLimit': '-0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.46', 'groupDescription': 'For cuff SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0731', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.03', 'ciLowerLimit': '-6.35', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.67', 'groupDescription': 'For cuff DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0077', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.49', 'ciLowerLimit': '-7.77', 'ciUpperLimit': '-1.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.65', 'groupDescription': 'For cuff DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0111', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.29', 'ciLowerLimit': '-7.58', 'ciUpperLimit': '-1.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.66', 'groupDescription': 'For cuff DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (pre dose value on Day 1 of treatment), Day 28', 'description': "At Baseline and Day 28 visit, sitting cuff SBP and DBP was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the first BP was obtained. The BP measurement was done in duplicate approximately 5 minutes apart. The mean of duplicate measurements was recorded.", 'unitOfMeasure': 'millimeter of mercury', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cuff SBP and DBP at Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'title': 'Cuff SBP', 'categories': [{'measurements': [{'value': '0.4', 'spread': '10.18', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '11.39', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '10.96', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '13.07', 'groupId': 'OG003'}]}]}, {'title': 'Cuff DBP', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '6.76', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '7.47', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '7.58', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '7.86', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre dose value on Day 1 of treatment), Day 31', 'description': "At Baseline and Day 31 visit, sitting cuff SBP and DBP was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the first BP was obtained. The BP measurement was done in duplicate approximately 5 minutes apart. The mean of duplicate measurements was recorded.", 'unitOfMeasure': 'millimeter of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cuff Mean Arterial Pressure (MAP) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.59', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-4.54', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '-5.53', 'spread': '1.31', 'groupId': 'OG002'}, {'value': '-7.06', 'spread': '1.34', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2567', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.94', 'ciLowerLimit': '-5.32', 'ciUpperLimit': '1.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.70', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0860', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.94', 'ciLowerLimit': '-6.29', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.69', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0103', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.46', 'ciLowerLimit': '-7.85', 'ciUpperLimit': '-1.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.71', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (pre dose value on Day 1 of treatment), Day 28', 'description': "At Baseline and Day 28, sitting cuff MAP was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the first MAP was obtained. The MAP measurement was done in duplicate approximately 5 minutes apart. The mean of duplicate measurements was recorded.", 'unitOfMeasure': 'millimeter of mercury', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)', 'description': 'Criteria for laboratory abnormalities included: hemoglobin, hematocrit, red blood cell count, total neutrophils, total protein, albumin: \\<0.8\\* limit of normal (LLN). Platelets: less than (\\<)0.5\\* LLN, greater than (\\>)1.75\\* upper limit of normal (ULN); white blood cell, glucose: \\<0.6\\*LLN, \\>1.5\\*ULN, lymphocytes: \\<0.8\\*LLN; \\>1.2\\*ULN; basophils, monocytes, eosinophils, total protein, albumin, uric acid: \\>1.2\\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \\>3.0\\*ULN; blood urea nitrogen, creatinine: \\>1.3\\*ULN; sodium: \\<0.95\\*LLN, \\>1.05\\*ULN; potassium, chloride, calcium: \\<0.9\\*LLN, \\>1.1\\*ULN; creatine kinase: \\> 2.0\\*ULN, \\> 3.0\\*ULN, \\>10.0\\*ULN; total bilirubin, direct bilirubin, indirect bilirubin:\\>1.5\\*ULN; urinalysis: urine pH: \\<4.5, \\>8, glucose, ketones, protein, blood/hemoglobin: \\>=1, RBC, WBC, epithelial cells: \\>=6, casts: \\>1, bacteria: \\>20.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate at Baseline, Day 1, 7, 14, 21, 28 and 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.5', 'spread': '8.76', 'groupId': 'OG000'}, {'value': '69.2', 'spread': '8.43', 'groupId': 'OG001'}, {'value': '67.9', 'spread': '8.63', 'groupId': 'OG002'}, {'value': '68.3', 'spread': '7.90', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '6.04', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '6.64', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '7.42', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '8.14', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '5.92', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '7.44', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '9.60', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '8.47', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '5.35', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '8.08', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '8.23', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '7.15', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '7.27', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '9.18', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '8.55', 'groupId': 'OG002'}, {'value': '4.9', 'spread': '8.70', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '7.77', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '7.78', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '9.31', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '9.38', 'groupId': 'OG003'}]}]}, {'title': 'Change at Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '8.17', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '8.76', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '8.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre dose value on Day 1 of treatment), Day 1, 7, 14, 21, 28, 31', 'description': "Sitting heart rate was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the heart rate was measured. The heart rate was measured for a minimum of 30 seconds, and the average of two measurements was recorded. Heart rate was measured in beats per minute.", 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized subjects who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "number analyzed" signifies participants evaluable at specific time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'OG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)', 'description': "Following ECG parameters were evaluated: QT interval, QTc interval, RR interval, PR interval, QRS complex and heart rate. Clinical significant ECG findings were determined by the investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who took at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'FG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 milligram (mg) (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'FG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'FG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Participants no longer willing to participate in study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 426 participants were screened, of whom 291 participants were screen failed and 135 participants were enrolled in the study and assigned to study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '133', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'BG001', 'title': 'PF-00489791 4 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'BG002', 'title': 'PF-00489791 10 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'BG003', 'title': 'PF-00489791 20/40 mg', 'description': 'Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18-44 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': '45-64 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}]}, {'title': 'Greater than or equal to (>=) 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants who took at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'dispFirstSubmitDate': '2009-04-06', 'completionDateStruct': {'date': '2008-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2007-01-12', 'dispFirstSubmitQcDate': '2009-10-07', 'resultsFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2007-01-12', 'dispFirstPostDateStruct': {'date': '2009-10-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-13', 'studyFirstPostDateStruct': {'date': '2007-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28', 'timeFrame': 'From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28', 'description': 'The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean daytime SBP was an average of SBP measurements taken between 08:00 and 16:00 hours by ABPM device on the specified time points. In this outcome measure change from baseline in mean daytime SBP at Day 28 is reported.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) as Measured by ABPM at Day 28', 'timeFrame': 'From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28', 'description': 'The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean daytime DBP was an average of DBP measurements taken between 08:00 and 16:00 hours by ABPM device on the specified time points. In this outcome measure change from baseline in mean daytime DBP at Day 28 is reported.'}, {'measure': 'Change From Baseline in Mean 24-Hour SBP and DBP as Measured by ABPM at Day 28', 'timeFrame': 'Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28', 'description': 'The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean 24-hour SBP and DBP was an average of SBP and DBP measurements, respectively, taken for 24 hours by ABPM device respectively. In this outcome measure change from baseline in mean 24-hour SBP and DBP at Day 28 is reported.'}, {'measure': 'Minimum and Maximum SBP and DBP as Measured by ABPM Over 24 Hours on Baseline, Day 1, 14 and 28', 'timeFrame': 'Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug), Day 1, 14 and 28', 'description': 'The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed on Baseline, Day 1, 14 and 28. In this outcome measure maximum and minimum SBP and DBP values recorded by ABPM device over 24 hours on Baseline, Day 1, 14 and 28 are reported.'}, {'measure': 'Change From Baseline in Cuff SBP and DBP at Day 28', 'timeFrame': 'Baseline (pre dose value on Day 1 of treatment), Day 28', 'description': "At Baseline and Day 28 visit, sitting cuff SBP and DBP was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the first BP was obtained. The BP measurement was done in duplicate approximately 5 minutes apart. The mean of duplicate measurements was recorded."}, {'measure': 'Change From Baseline in Cuff SBP and DBP at Day 31', 'timeFrame': 'Baseline (pre dose value on Day 1 of treatment), Day 31', 'description': "At Baseline and Day 31 visit, sitting cuff SBP and DBP was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the first BP was obtained. The BP measurement was done in duplicate approximately 5 minutes apart. The mean of duplicate measurements was recorded."}, {'measure': 'Change From Baseline in Cuff Mean Arterial Pressure (MAP) at Day 28', 'timeFrame': 'Baseline (pre dose value on Day 1 of treatment), Day 28', 'description': "At Baseline and Day 28, sitting cuff MAP was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the first MAP was obtained. The MAP measurement was done in duplicate approximately 5 minutes apart. The mean of duplicate measurements was recorded."}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'timeFrame': 'Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)', 'description': 'Criteria for laboratory abnormalities included: hemoglobin, hematocrit, red blood cell count, total neutrophils, total protein, albumin: \\<0.8\\* limit of normal (LLN). Platelets: less than (\\<)0.5\\* LLN, greater than (\\>)1.75\\* upper limit of normal (ULN); white blood cell, glucose: \\<0.6\\*LLN, \\>1.5\\*ULN, lymphocytes: \\<0.8\\*LLN; \\>1.2\\*ULN; basophils, monocytes, eosinophils, total protein, albumin, uric acid: \\>1.2\\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \\>3.0\\*ULN; blood urea nitrogen, creatinine: \\>1.3\\*ULN; sodium: \\<0.95\\*LLN, \\>1.05\\*ULN; potassium, chloride, calcium: \\<0.9\\*LLN, \\>1.1\\*ULN; creatine kinase: \\> 2.0\\*ULN, \\> 3.0\\*ULN, \\>10.0\\*ULN; total bilirubin, direct bilirubin, indirect bilirubin:\\>1.5\\*ULN; urinalysis: urine pH: \\<4.5, \\>8, glucose, ketones, protein, blood/hemoglobin: \\>=1, RBC, WBC, epithelial cells: \\>=6, casts: \\>1, bacteria: \\>20.'}, {'measure': 'Change From Baseline in Heart Rate at Baseline, Day 1, 7, 14, 21, 28 and 31', 'timeFrame': 'Baseline (pre dose value on Day 1 of treatment), Day 1, 7, 14, 21, 28, 31', 'description': "Sitting heart rate was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the heart rate was measured. The heart rate was measured for a minimum of 30 seconds, and the average of two measurements was recorded. Heart rate was measured in beats per minute."}, {'measure': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings', 'timeFrame': 'Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)', 'description': "Following ECG parameters were evaluated: QT interval, QTc interval, RR interval, PR interval, QRS complex and heart rate. Clinical significant ECG findings were determined by the investigator's discretion."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clinical Trial', 'Randomized Controlled Trial', 'Humans', 'Cyclic Nucleotide Phosphodiesterases Type 5'], 'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7331007&StudyName=A%20Dose%20Finding%20Study%20Of%20PF-00489791%20In%20Patients%20With%20Mild%20To%20Moderate%20High%20Blood%20Pressure', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and blood pressure lowering effect of different doses of PF-00489791 in patients with mild to moderate high blood pressure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and/or Females of non-childbearing potential between 18 and 70 years of age\n2. History of mild to moderate hypertension\n\nExclusion Criteria:\n\n1. Type 1 or 2 diabetes on prescribed medications\n2. Secondary, severe, or malignant hypertension\n3. History of a significant cardiovascular event within the last 12 months of enrollment'}, 'identificationModule': {'nctId': 'NCT00422461', 'briefTitle': 'A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY OF PF-00489791 IN SUBJECTS WITH STAGE 1 AND 2 ESSENTIAL HYPERTENSION USING AMBULATORY BLOOD PRESSURE MONITORING (ABPM)', 'orgStudyIdInfo': {'id': 'A7331007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PF-00489791 20 mg titrated to 40 mg', 'interventionNames': ['Drug: PF-00489791']}, {'type': 'EXPERIMENTAL', 'label': 'PF-00489791 4 mg', 'interventionNames': ['Drug: PF-00489791']}, {'type': 'EXPERIMENTAL', 'label': 'PF-00489791 10 mg', 'interventionNames': ['Drug: PF-00489791']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'placebo, oral, tablets, once daily, for 28 days', 'armGroupLabels': ['Placebo']}, {'name': 'PF-00489791', 'type': 'DRUG', 'description': 'PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days', 'armGroupLabels': ['PF-00489791 20 mg titrated to 40 mg']}, {'name': 'PF-00489791', 'type': 'DRUG', 'description': 'PF-00489791 4 mg, oral, tablets, once daily, for 28 days', 'armGroupLabels': ['PF-00489791 4 mg']}, {'name': 'PF-00489791', 'type': 'DRUG', 'description': 'PF-00489791 10 mg, oral, tablets, once daily, for 28 days', 'armGroupLabels': ['PF-00489791 10 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Apex 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