Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension
NCT00095394 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 645
Last updated 2011-04-15
Summary
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.
Conditions
Interventions
- DRUG
-
Irbesartan/HCTZ
Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
- DRUG
-
Irbesartan monotherapy
Tablets, Oral, 150 mg, Once daily, 7 weeks.
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-30
- Primary Completion
- 2005-05-31
- Completion
- 2005-05-31
Countries
- United States
- Belgium
- Canada
- France
- Germany
- Israel
- Netherlands
- Russia
Study Locations
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