Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-11 @ 10:02 AM
Study NCT ID:
NCT00143195
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2005-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D007547', 'term': 'Isosorbide'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013012', 'term': 'Sorbitol'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2005-01'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the time to 1mm ST depression'}], 'secondaryOutcomes': [{'measure': 'The number of patients experiencing angina attacks The frequency of hospitalizations due to angina attacks Time to onset of 1mm ST segment depression Total external workload performed Safety'}]}, 'conditionsModule': {'conditions': ['Myocardial Ischemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0531076&StudyName=Amlodipine+vs+NItrates+Study+in+Patients+with+Chronic+Stable++Angina+%28ANISSA%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients \\> =18 years of age with diagnosed clinically stable angina pectoris\n\nExclusion Criteria:\n\n* Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG'}, 'identificationModule': {'nctId': 'NCT00143195', 'acronym': 'ANISSA', 'briefTitle': 'Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Open Label Study Comparing Amlodipine vs Long-acting Nitrates in Patients With Chronic Stable Angina.', 'orgStudyIdInfo': {'id': 'A0531076'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Amlodipine', 'type': 'DRUG'}, {'name': 'iso- 5 - mononitrate', 'type': 'DRUG'}, {'name': 'Blood tests', 'type': 'PROCEDURE'}, {'name': 'Exercise Stress Test', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '123 51', 'city': 'Athens', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11525', 'city': 'Holargos/Athens', 'country': 'Greece', 'facility': 'Pfizer Investigational Site'}, {'zip': '45500', 'city': 'Loannina', 'country': 'Greece', 'facility': 'Pfizer Investigational Site'}, {'zip': '143 88', 'city': 'N. Ionia', 'country': 'Greece', 'facility': 'Pfizer Investigational Site'}, {'zip': '26335', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '26499', 'city': 'Rio, Patra', 'country': 'Greece', 'facility': 'Pfizer Investigational Site'}, {'zip': '546 36', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54639', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Voula/Athens', 'country': 'Greece', 'facility': 'Pfizer Investigational Site'}, {'zip': '29100', 'city': 'Zakynthos', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.78022, 'lon': 20.89555}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}