Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 8:26 PM
Study NCT ID:
NCT00500604
Status:
COMPLETED
Last Update Posted:
2010-07-19
First Post:
2007-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate 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': 'D000077405', 'term': 'Irbesartan'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D000068756', 'term': 'Valsartan'}], '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': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1617}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-16', 'studyFirstSubmitDate': '2007-07-11', 'studyFirstSubmitQcDate': '2007-07-11', 'lastUpdatePostDateStruct': {'date': '2010-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in mean SBP as measured by HBPM', 'timeFrame': 'From week 0 to week 24'}], 'secondaryOutcomes': [{'measure': 'Reduction in mean DBP as measured by HBPM', 'timeFrame': 'From week 0 to weeks 16 and 24'}, {'measure': 'Reduction in mean morning and evening SBP as measured by HBPM', 'timeFrame': 'From week 0 to weeks 16 and 24'}, {'measure': 'Reduction in mean morning and evening DBP as measured by HBPM', 'timeFrame': 'From week 0 to weeks 16 and 24'}, {'measure': "Reduction in mean SBP and mean DBP evaluated at the doctor's office", 'timeFrame': 'From week 0 to weeks 16 and 24'}, {'measure': 'Number of normalised patients as measured by HBPM', 'timeFrame': 'From week 0 to weeks 16 and 24'}, {'measure': "Number of normalised patients evaluated at the doctor's office", 'timeFrame': 'From week 0 to weeks 16 and 24'}, {'measure': 'Reduction in mean SBP as measured by HBPM', 'timeFrame': 'From week 0 to week 16'}, {'measure': 'Adverse events, vital signs, laboratory tests', 'timeFrame': 'From visit 1 to end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': "The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.\n\nThe secondary objectives are:\n\n* To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24\n* To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24\n* To compare the difference in mean SBP evaluated by HBPM at week 16\n* To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24\n* To determine the incidence and severity of adverse events"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Established essential hypertension, untreated or treated but uncontrolled with treatment:\n\n * Office SBP ≥ 160 mmHg for untreated patients\n * Office SBP ≥ 140 mmHg for patients already treated with an antihypertensive drug.\n* Previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:\n\n * ACE inhibitor / calcium channel blocker\n * Beta blocker / calcium channel blocker\n * Beta blocker / low dose diuretic\n * ACE inhibitor / low dose diuretic\n\nExclusion Criteria:\n\n* SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg evaluated at doctor's office at Visit 1\n* Known or suspected causes of secondary hypertension\n* Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney\n* Type 1 diabetes mellitus\n* Significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the Investigator to make participation in the study not in the best interest of the subject\n* Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used\n* Known contraindications to any of the study drugs\n* Concomitant use of any other antihypertensive treatment\n* Use of any of the investigational products for this study within the 3 months prior to the study\n* Inability to obtain a valid HBPM recording i.e., obesity, arm circumference \\> 32 cm or arrhythmia\n* Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study\n* Pregnant or breast-feeding women\n* Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00500604', 'acronym': 'COSIMA2', 'briefTitle': 'Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Comparative Study of the Efficacy of Irbesartan/Hydrochlorothiazide 300/25 mg Versus Valsartan/Hydrochlorothiazide 160/25 mg Using Home Blood Pressure Monitoring in the Treatment of Mild to Moderate Hypertension', 'orgStudyIdInfo': {'id': 'IRBEH_R_02584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': '* period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks\n* period 2: One 150/12.5mg tablet every morning for 8 weeks.\n* period 3: One 300/12.5mg tablet every morning for 8 weeks.\n* period 4: Two 150/12.5mg tablets every morning for 8 weeks.', 'interventionNames': ['Drug: Irbesartan/hydrochlorothiazide', 'Drug: Hydrochlorothiazide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': '* period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks\n* period 2: One 80/12.5mg tablet every morning for 8 weeks.\n* period 3: One 160/12.5mg tablet every morning for 8 weeks.\n* period 4: Two 80/12.5mg tablets every morning for 8 weeks.', 'interventionNames': ['Drug: Valsartan/hydrochlorothiazide', 'Drug: Hydrochlorothiazide']}], 'interventions': [{'name': 'Irbesartan/hydrochlorothiazide', 'type': 'DRUG', 'description': '150/12.5mg tablet and 300/12.5mg tablet', 'armGroupLabels': ['A']}, {'name': 'Valsartan/hydrochlorothiazide', 'type': 'DRUG', 'description': '80/12.5mg tablet and 160/12.5mg tablet', 'armGroupLabels': ['B']}, {'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'description': '12.5 mg administered orally, once daily in the morning', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Casablanca', 'country': 'Morocco', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 33.58831, 'lon': -7.61138}}, {'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Makati City', 'country': 'Philippines', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Mégrine', 'country': 'Tunisia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 36.76917, 'lon': 10.23639}}, {'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Benedict Blayney', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}