Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-04 @ 4:31 PM
Study NCT ID:
NCT00095394
Status:
COMPLETED
Last Update Posted:
2011-04-15
First Post:
2004-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe 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': 645}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'dispFirstSubmitDate': '2010-02-15', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2004-11-03', 'dispFirstSubmitQcDate': '2010-02-15', 'studyFirstSubmitQcDate': '2004-11-03', 'dispFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5'}], 'secondaryOutcomes': [{'measure': 'Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.'}]}, 'conditionsModule': {'keywords': ['Severe Hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research is to learn if severe 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* Men and women ages 18 and older;\n* Willing to provide written informed consent;\n* Must have uncontrolled hypertension defined as: currently untreated with a diastolic blood pressure greater than 110 mmHg OR currently receiving antihypertensive monotherapy with a diastolic blood pressure greater than 100 mmHg. Monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy;\n* Must be willing to discontinue antihypertensive medication, if applicable;\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.\n* 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 6 months;\n* Significant kidney disease;\n* Significant liver disease;\n* Systemic lupus erythematosus;\n* Gastrointestinal disease or surgery that may 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': 'NCT00095394', 'briefTitle': 'Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension', 'orgStudyIdInfo': {'id': 'CV131-176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1', 'interventionNames': ['Drug: Irbesartan/HCTZ']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A2', 'interventionNames': ['Drug: Irbesartan monotherapy']}], 'interventions': [{'name': 'Irbesartan/HCTZ', 'type': 'DRUG', 'otherNames': ['Avapro'], 'description': 'Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.', 'armGroupLabels': ['A1']}, {'name': 'Irbesartan monotherapy', 'type': 'DRUG', 'otherNames': ['Avapro'], 'description': 'Tablets, Oral, 150 mg, Once daily, 7 weeks.', 'armGroupLabels': ['A2']}]}, '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': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United 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