Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-31 @ 3:49 AM
Study NCT ID:
NCT01244035
Status:
COMPLETED
Last Update Posted:
2019-02-28
First Post:
2010-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C494814', 'term': 'BID protein, human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo', 'eventGroups': [{'id': 'EG000', 'title': 'MK-8266 1.3 mg BID', 'description': 'MK-8266 administered as 1.0 mg in the morning + 0.3 mg 8 hours later on Days 1, 2, and 3', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 9, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MK-8266 0.9 mg FDD', 'description': 'MK-8266 administered as 0.1 mg every 2 hours on Days 1, 2, and 3', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 16, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MK-8266 1 mg QD', 'description': 'MK-8266 administered a single 1 mg dose on Day 4', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 8, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo matching MK-8266 administered on Days 1, 2, 3 and 4', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 9, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Accelerated idioventricular rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vessel puncture site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Agitation', 'stats': [{'groupId': 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8266 1.3 mg BID', 'description': 'Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.'}, {'id': 'OG001', 'title': 'MK-8266 0.9 mg FDD', 'description': 'Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.'}, {'id': 'OG002', 'title': 'MK-8266 1 mg QD', 'description': 'Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE was reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo', 'description': "The number of participants with one or more clinical or laboratory AEs was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study treatment'}, {'type': 'PRIMARY', 'title': 'Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Days 1 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8266 1.3 mg BID; MK-8266 1 mg QD', 'description': 'Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.'}, {'id': 'OG001', 'title': 'MK-8266 0.9 mg FDD; MK-8266 1 mg QD', 'description': 'Participants receiving MK-8266 0.9 mg FDD on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '83.4', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '5.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '120', 'spread': '41.7', 'groupId': 'OG000'}, {'value': '69.3', 'spread': '25.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, and 8 hours after dosing on Day 1, and pre-dose and 4 and 8 hours after dosing on Day 3 of each period', 'description': 'The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.', 'unitOfMeasure': 'nM*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had assessment of AUC(0-8 hours)'}, {'type': 'PRIMARY', 'title': 'Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8266 1.3 mg BID; MK-8266 1 mg QD', 'description': 'Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.'}, {'id': 'OG001', 'title': 'MK-8266 0.9 mg FDD; MK-8266 1 mg QD', 'description': 'Participants receiving MK-8266 0.9 mg FDD on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'spread': '46.6', 'groupId': 'OG000'}, {'value': '139', 'spread': '43.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose and 2, 4, and 8 hours after dosing on Day 4 of each period', 'description': 'The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.', 'unitOfMeasure': 'nM*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had assessment of AUC(0-8 hours)'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of MK-8266 on Day 1 and Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8266 1.3 mg BID', 'description': 'All Treatment Sequences (A, B, C) for Day 1 to Day 3'}, {'id': 'OG001', 'title': 'MK-8266 0.9 mg FDD', 'description': 'All Treatment Sequences (A, B, C) for Day 1 to Day 3'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '17.4', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '8.63', 'spread': '2.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '20.5', 'spread': '6.11', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '3.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3', 'description': 'The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had assessment for Cmax'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of MK-8266 on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8266 1.3 mg BID; MK-8266 1 mg QD', 'description': 'Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.'}, {'id': 'OG001', 'title': 'MK-8266 0.9 mg FDD; MK-8266 1 mg QD', 'description': 'Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'spread': '7.28', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '6.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose and 2, 4, and 8 hours after dosing on Day 4 of each period', 'description': 'The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had assessment for Cmax'}, {'type': 'PRIMARY', 'title': 'Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 1 and Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8266 1.3 mg BID', 'description': 'All Treatment Sequences (A, B, C) for Day 1 to Day 3'}, {'id': 'OG001', 'title': 'MK-8266 0.9 mg FDD', 'description': 'All Treatment Sequences (A, B, C) for Day 1 to Day 3'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '12.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '24.0'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '12.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '24.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3', 'description': 'The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 1 and Day 3.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had assessment for Tmax'}, {'type': 'PRIMARY', 'title': 'Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1.3 mg BID; MK-8266 1 mg QD', 'description': 'Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.'}, {'id': 'OG001', 'title': 'MK-8266 0.9 mg FDD, MK-8266 1 mg QD', 'description': 'Participants receiving MK-8266 0.9 mg FDD on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '8.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and 2, 4, and 8 hours after dosing on Day 4 of each period', 'description': 'The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 4.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had assessment for Tmax'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Heart Rate (HR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8266 0.9 mg FDD', 'description': 'MK-8266 administered as 0.1 mg every 2 hours (total dose of 0.9 mg) on Days 1, 2, and 3'}, {'id': 'OG001', 'title': 'MK-8266 1.3 mg BID', 'description': 'MK-8266 administered as 1.0 mg in the morning + 0.3 mg 8 hours later on Days 1, 2, and 3'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered at time points matching administration of MK-8266 on Days 1, 2, and 3'}], 'classes': [{'categories': [{'measurements': [{'value': '2.78', 'spread': '6.67', 'groupId': 'OG000'}, {'value': '5.84', 'spread': '3.94', 'groupId': 'OG001'}, {'value': '1.68', 'spread': '3.67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1325', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.10', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '2.74', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Period and treatment were fixed effects and participant was a random effect.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.16', 'ciLowerLimit': '2.53', 'ciUpperLimit': '5.79', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Period and treatment were fixed effects and participant was a random effect.'}, {'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.06', 'ciLowerLimit': '-4.70', 'ciUpperLimit': '-1.42', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Period and treatment were fixed effects and participant was a random effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3', 'description': 'The effect of MK-8266 and placebo on changes in HR were assessed, as measured by time weighted average change from baseline in HR over 0-24 hours postdose (TWA\\^0-24 hr) on Day 3. Baseline values for HR are shown in the Baseline Characteristics section.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had HR measurements'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8266 0.9 mg FDD', 'description': 'MK-8266 administered as 0.1 mg every 2 hours (total dose of 0.9 mg) on Days 1, 2, and 3'}, {'id': 'OG001', 'title': 'MK-8266 1.3 mg BID', 'description': 'MK-8266 administered as 1.0 mg in the morning + 0.3 mg 8 hours later on Days 1, 2, and 3'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered at time points matching administration of MK-8266 on Days 1, 2, and 3'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.21', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '-3.04', 'spread': '5.30', 'groupId': 'OG001'}, {'value': '-0.28', 'spread': '4.68', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0212', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.94', 'ciLowerLimit': '-5.30', 'ciUpperLimit': '-0.57', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Period and treatment were fixed effects and participant was a random effect.'}, {'pValue': '0.0299', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.76', 'ciLowerLimit': '-5.16', 'ciUpperLimit': '-0.36', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Period and treatment were fixed effects and participant was a random effect.'}, {'pValue': '0.4506', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.18', 'ciLowerLimit': '-2.54', 'ciUpperLimit': '2.19', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Period and treatment were fixed effects and participant was a random effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3', 'description': 'The effect of MK-8266 and placebo on changes in diastolic blood pressure (DBP) were assessed, as measured by time weighted average change from baseline in DBP over 0-24 hours postdose (TWA\\^0-24 hr) on Day 3. Baseline values for DBP are shown in the Baseline Characteristics section.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had DBP measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence ABC', 'description': 'MK-8266 1.3 mg BID, then MK-8266 0.9 mg FDD, then Placebo'}, {'id': 'FG001', 'title': 'Sequence ACB', 'description': 'MK-8266 1.3 mg BID, then Placebo, then MK-8266 0.9 mg FDD'}, {'id': 'FG002', 'title': 'Sequence BCA', 'description': 'MK-8266 0.9 mg FDD, then Placebo, then MK-8266 1.3 mg BID'}, {'id': 'FG003', 'title': 'Sequence BAC', 'description': 'MK-8266 0.9 mg FDD, then MK-8266 1.3 mg BID, then Placebo'}, {'id': 'FG004', 'title': 'Sequence CAB', 'description': 'Placebo, then MK-8266 1.3 mg BID, then MK-8266 0.9 mg FDD'}, {'id': 'FG005', 'title': 'Sequence CBA', 'description': 'Placebo, then MK-8266 0.9 mg FDD, then MK-8266 1.3 mg BID'}], 'periods': [{'title': 'Part 1: Period 1', 'milestones': [{'type': 'STARTED', 'comment': 'This was a 3-period crossover study with a 4-day washout between treatment periods', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Fulfilled Stopping Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Part 1: Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Fulfilled Stopping Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Part 1: Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The same participants in Part 1 were to continue in Part 2, pending the planned evaluation of Part 1 pharmacodynamic results. Based on the Part 1 results, no participants continued to Part 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants, All Sequences', 'description': 'A: MK-8266 1.3 mg BID, B: MK-8266 0.9 mg FDD, C: Placebo'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Total of 31 participants in Sequences A, B, and C'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heart Rate (HR)', 'classes': [{'categories': [{'measurements': [{'value': '78.00', 'spread': '8.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'HR summary for the enrolled population', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants who were randomized to receive study treatment and had HR measurement'}, {'title': 'Diastolic Blood Pressure (DBP)', 'classes': [{'categories': [{'measurements': [{'value': '93.36', 'spread': '5.08', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'DBP summary for the enrolled population', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants who were randomized to receive study treatment and had DBP measurement'}], 'populationDescription': 'This was a 3-period crossover study, with a total of 31 randomized participants at Baseline in Sequences A, B, and C.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2010-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-24', 'studyFirstSubmitDate': '2010-11-17', 'resultsFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-24', 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': 'MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE was reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo', 'description': "The number of participants with one or more clinical or laboratory AEs was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product."}, {'measure': 'Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Days 1 and 3', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, and 8 hours after dosing on Day 1, and pre-dose and 4 and 8 hours after dosing on Day 3 of each period', 'description': 'The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.'}, {'measure': 'Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Day 4', 'timeFrame': 'Predose and 2, 4, and 8 hours after dosing on Day 4 of each period', 'description': 'The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-8266 on Day 1 and Day 3', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3', 'description': 'The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-8266 on Day 4', 'timeFrame': 'Predose and 2, 4, and 8 hours after dosing on Day 4 of each period', 'description': 'The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 1 and Day 3', 'timeFrame': 'Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3', 'description': 'The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 1 and Day 3.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 4', 'timeFrame': 'Predose and 2, 4, and 8 hours after dosing on Day 4 of each period', 'description': 'The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 4.'}, {'measure': 'Change From Baseline in Heart Rate (HR)', 'timeFrame': 'Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3', 'description': 'The effect of MK-8266 and placebo on changes in HR were assessed, as measured by time weighted average change from baseline in HR over 0-24 hours postdose (TWA\\^0-24 hr) on Day 3. Baseline values for HR are shown in the Baseline Characteristics section.'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure (DBP)', 'timeFrame': 'Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3', 'description': 'The effect of MK-8266 and placebo on changes in diastolic blood pressure (DBP) were assessed, as measured by time weighted average change from baseline in DBP over 0-24 hours postdose (TWA\\^0-24 hr) on Day 3. Baseline values for DBP are shown in the Baseline Characteristics section.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High blood pressure'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This was designed as a two part study comprising sequential double-dummy, placebo controlled 3-period randomized crossover studies. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of different doses and dose regimens of MK-8266. Only Part I of the study was completed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant has essential hypertension who is in grade 1 or 2 hypertension according to the European Society of Hypertension (ESH) as delineated in the European Society of Cardiology (ESC) 2007 guidelines, i.e. systolic blood pressure values of 140-179 and diastolic blood pressure values of 90-109 on at least 3 occasions prior to the study.\n* Otherwise healthy participants with grade 1 or 2 arterial hypertension who are treated with a single antihypertensive drug and meet the above blood pressure criteria may be enrolled at the discretion of the investigator\n* Participant is generally in good health with the exception of hypertension\n* Participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for 6 months\n\nExclusion Criteria:\n\n* Participant has a history of any illness that might confound the results of the study or pose and additional risk to the participant if they take part in the study\n* Participant has a history of stroke, chronic seizures, or major neurological disorder\n* Participant has a disability that can interfere with rising from a semi-recumbent position to the standing position\n* Participant has a personal or family history of a bleeding or clotting disorder\n* Participant has a history of frequent nosebleeds or recurrent or active gingivitis\n* Participant has a history of cancer, except 1) certain skin cancers; 2) cancer successfully treated more than 10 years prior to the study that has not recurred; or, 3) participants who are unlikely to have a recurrence during the study\n* Participant has a history of cardiac disease including but not limited to heart valve disease or evidence of secondary cardiac damage\n* Participant is categorized as class II or greater according to the New York Heart Association (NYHA) functional classification for heart failure\n* Participant is unable to refrain from use of prescription or non-prescription drugs or herbal remedies (such as St. John's Wort) during the study\n* Participant anticipates using phosphodiesterase (PDE5) inhibitors \\[sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®)\\] during the study\n* Participant consumes excessive amounts of alcohol (more than 3 drinks per day) or caffeine (more than 6 servings a day)\n* Participant has had major surgery, donated or lost 1 unit of blood, or participated in another investigational within 4 weeks prior to the study\n* Participant has a history of multiple and/or severe allergies, or has had an anaphylactic reaction or intolerance to any drugs or food"}, 'identificationModule': {'nctId': 'NCT01244035', 'briefTitle': 'Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics Following Different Dosing Regimens of MK-8266 or Placebo in Subjects With Hypertension', 'orgStudyIdInfo': {'id': '8266-008'}, 'secondaryIdInfos': [{'id': '2010-021832-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part I - Sequence ABC', 'description': 'Treatment A in Period 1, Treatment B in Period 2, and Treatment C in Period 3', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - Sequence ACB', 'description': 'Treatment A in Period 1, Treatment C in Period 2, and Treatment B in Period 3', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - Sequence BCA', 'description': 'Treatment B in Period 1, Treatment C in Period 2, and Treatment A in Period 3', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - Sequence BAC', 'description': 'Treatment B in Period 1, Treatment A in Period 2, and Treatment C in Period 3', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - Sequence CAB', 'description': 'Treatment C in Period 1, Treatment A in Period 2, and Treatment B in Period 3', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Part I - Sequence CBA', 'description': 'Treatment C in Period 1, Treatment B in Period 2, and Treatment A in Period 3', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Part II - Sequence DEF', 'description': 'Treatment D in Period 1, Treatment E in Period 2, and Treatment F in Period 3', 'interventionNames': ['Drug: Treatment D', 'Drug: Treatment E', 'Drug: Treatment F']}, {'type': 'EXPERIMENTAL', 'label': 'Part II - Sequence DFE', 'description': 'Treatment D in Period 1, Treatment F in Period 2, and Treatment E in Period 3', 'interventionNames': ['Drug: Treatment D', 'Drug: Treatment E', 'Drug: Treatment F']}, {'type': 'EXPERIMENTAL', 'label': 'Part II - Sequence EFD', 'description': 'Treatment E in Period 1, Treatment F in Period 2, and Treatment D in Period 3', 'interventionNames': ['Drug: Treatment D', 'Drug: Treatment E', 'Drug: Treatment F']}, {'type': 'EXPERIMENTAL', 'label': 'Part II - Sequence EDF', 'description': 'Treatment E in Period 1, Treatment D in Period 2, and Treatment F in Period 3', 'interventionNames': ['Drug: Treatment D', 'Drug: Treatment E', 'Drug: Treatment F']}, {'type': 'EXPERIMENTAL', 'label': 'Part II - Sequence FDE', 'description': 'Treatment F in Period 1, Treatment D in Period 2, and Treatment E in Period 3', 'interventionNames': ['Drug: Treatment D', 'Drug: Treatment E', 'Drug: Treatment F']}, {'type': 'EXPERIMENTAL', 'label': 'Part II -Sequence FED', 'description': 'Treatment F in Period 1, Treatment E in Period 2, and Treatment D in Period 3', 'interventionNames': ['Drug: Treatment D', 'Drug: Treatment E', 'Drug: Treatment F']}], 'interventions': [{'name': 'Treatment A', 'type': 'DRUG', 'otherNames': ['MK-8266 1.3 mg BID'], 'description': 'MK-8266 1.3 mg orally twice daily (BID, 1 mg in the morning and 0.3 mg 8 hours later) plus placebo to match Treatment B on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.', 'armGroupLabels': ['Part I - Sequence ABC', 'Part I - Sequence ACB', 'Part I - Sequence BAC', 'Part I - Sequence BCA', 'Part I - Sequence CAB', 'Part I - Sequence CBA']}, {'name': 'Treatment B', 'type': 'DRUG', 'otherNames': ['MK-8266 0.9 mg FDD'], 'description': 'MK-8266 0.1 mg orally administered every 2 hours as frequent divided dosing (FDD, total dose of 0.9 mg) plus placebo to match Treatment A on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.', 'armGroupLabels': ['Part I - Sequence ABC', 'Part I - Sequence ACB', 'Part I - Sequence BAC', 'Part I - Sequence BCA', 'Part I - Sequence CAB', 'Part I - Sequence CBA']}, {'name': 'Treatment C', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo to match MK-8266 Treatments A and B orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.', 'armGroupLabels': ['Part I - Sequence ABC', 'Part I - Sequence ACB', 'Part I - Sequence BAC', 'Part I - Sequence BCA', 'Part I - Sequence CAB', 'Part I - Sequence CBA']}, {'name': 'Treatment D', 'type': 'DRUG', 'description': 'MK-8266 orally twice daily (1 mg in the morning and 0.4 mg 8 hours later) plus placebo to match Treatment E on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.', 'armGroupLabels': ['Part II - Sequence DEF', 'Part II - Sequence DFE', 'Part II - Sequence EDF', 'Part II - Sequence EFD', 'Part II - Sequence FDE', 'Part II -Sequence FED']}, {'name': 'Treatment E', 'type': 'DRUG', 'description': 'MK-8266 0.2 mg orally every 2 hours (total dose of 1.4 mg) plus placebo to match Treatment D on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.', 'armGroupLabels': ['Part II - Sequence DEF', 'Part II - Sequence DFE', 'Part II - Sequence EDF', 'Part II - Sequence EFD', 'Part II - Sequence FDE', 'Part II -Sequence FED']}, {'name': 'Treatment F', 'type': 'DRUG', 'description': 'Placebo to match MK-8266 Treatments D and E orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.', 'armGroupLabels': ['Part II - Sequence DEF', 'Part II - Sequence DFE', 'Part II - Sequence EDF', 'Part II - Sequence EFD', 'Part II - Sequence FDE', 'Part II -Sequence FED']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinicaltrials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}