Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-21 @ 9:20 PM
Study NCT ID:
NCT00095550
Status:
COMPLETED
Last Update Posted:
2011-04-15
First Post:
2004-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With 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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 496}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'dispFirstSubmitDate': '2010-02-15', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2004-11-05', 'dispFirstSubmitQcDate': '2010-02-15', 'studyFirstSubmitQcDate': '2004-11-05', 'dispFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in SeSBP at Week 8'}], 'secondaryOutcomes': [{'measure': 'Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.'}]}, 'conditionsModule': {'keywords': ['Moderate Hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to provide written informed consent\n* Subjects must have uncontrolled hypertension defined as:\n\n * average systolic blood pressure between 160 mmHg and 180 mmHg (while diastolic blood pressure is less than 110 mmHg) or\n * average diastolic blood pressure between 100 mmHg and 110 mmHg (while systolic blood pressure is between 130 mmHg and 180 mmHg)\n* Subjects must be willing to discontinue their antihypertensive medication, if applicable.\n* Men and women, ages 18 and older will be included.\n* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Known or suspected secondary hypertension\n* Hypertension emergencies or stroke within the past 12 months.\n* Heart attack, angina or bypass surgery within the past six months.\n* Significant kidney disease\n* Significant liver disease\n* Systemic lupus erythematosus\n* Gastrointestinal disease or surgery that interfere with drug absorption\n* Cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin\n* Currently pregnant or lactating\n* Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study\n* Drug or alcohol abuse within the last five years\n* Known allergy to irbesartan or diuretics'}, 'identificationModule': {'nctId': 'NCT00095550', 'briefTitle': 'Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients With Moderate Hypertension', 'orgStudyIdInfo': {'id': 'CV131-185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1', 'interventionNames': ['Drug: Irbesartan/HCTZ']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A2', 'interventionNames': ['Drug: Irbesartan monotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A3', 'interventionNames': ['Drug: HCTZ monotherapy']}], 'interventions': [{'name': 'Irbesartan/HCTZ', 'type': 'DRUG', 'otherNames': ['Avapro'], 'description': 'Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.', 'armGroupLabels': ['A1']}, {'name': 'Irbesartan monotherapy', 'type': 'DRUG', 'otherNames': ['Avapro'], 'description': 'Tablets, Oral, 150 mg, Once daily, 12 weeks.', 'armGroupLabels': ['A2']}, {'name': 'HCTZ monotherapy', 'type': 'DRUG', 'description': 'Tablets, Oral, 12.5 mg, Once daily, 12 weeks.', 'armGroupLabels': ['A3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Columbiana', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.17817, 'lon': -86.60721}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'city': 'Fair Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.64463, 'lon': -121.27217}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Rolling Hills Estate', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution'}, {'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 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