Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT00281593
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2006-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D017257', 'term': 'Ramipril'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1354}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'statusVerifiedDate': '2017-12', 'lastUpdateSubmitDate': '2017-12-27', 'studyFirstSubmitDate': '2006-01-24', 'studyFirstSubmitQcDate': '2006-01-24', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in systolic blood pressure after 8 weeks of treatment Percentage of patients responding to treatment Changes from baseline in diastolic and systolic blood pressure hourly means over the 24 hour dosing interval as measured by ABPM'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/22272064', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To identify dose combinations of telmisartan and ramipril that are more effective in reducing diastolic blood pressure than each of the respective monotherapies in patients with Stage I or II hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients \\>=18 years of age with Stage I or II hypertension defined as:\n* a mean seated cuff diastolic blood pressure \\>=95 and \\<=119 mmHg Main\n\nExclusion Criteria:\n\n* Pregnant\n* breast-feeding\n* unwilling to use birth control during the study\n* secondary hypertension\n* SBP\\>=180 mmHg\n* DBP\\>=120 mmHg\n* severe renal dysfunction\n* hepatic insufficiency\n* stroke within the last 6 months\n* myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months\n* unstable or uncontrolled diabetes\n* history of angioedema of either of the study drugs, and hypersensitivity to the study drugs.'}, 'identificationModule': {'nctId': 'NCT00281593', 'briefTitle': 'Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study', 'orgStudyIdInfo': {'id': '1236.1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Telmisartan', 'type': 'DRUG'}, {'name': 'Ramipril', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': '1236.1.511 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': '1236.1.574 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': '1236.1.501 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': '1236.1.557 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': '1236.1.523 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': '1236.1.514 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': '1236.1.560 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': '1236.1.573 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '1236.1.516 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': '1236.1.529 Boehringer Ingelheim Investigational Site', 'geoPoint': 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