NCT00263003CompletedPhase 3
A Randomized, Open Label Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Compare the reduction in office BP following a 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan
Study Overview
Brief Summary
Study Objectives :
- To demonstrate the reduction in office Blood Pressure following a 8-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference.
- To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference.
- To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan.
- To compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
- To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with mild to moderate hypertension with office Diastolic Blood Pressure (DBP) 90-109 mmHg and/or Systolic Blood Pressure (SBP) 140-179 mmHg
- •All women of child-bearing potential must have negative urine pregnancy tests within a week prior to initiation of therapy
Exclusion Criteria
- •females who are pregnant or breast feeding
- •office DBP ≥ 110 mmHg or office SBP ≥ 180 mmHg
- •history of significant cardiovascular diseases which includes:
- •acute myocardial infarction within six months or any ischemic heart disease requiring medication.
- •cerebrovascular disease
- •history of significant renal diseases including:
- •serum creatinine > 3.0 mg/dl.
- •creatinine clearance < 30 ml/min.
- •severe biliary cirrhosis and cholestasis
- •refractory hypokalemia, hypercalcemia
- •history of autoimmune disease, collagen vascular disease, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
- •hepatic disease as indicated by any of the following:
- •SGOT or SGPT >3 x upper limit of normal.
- •Serum bilirubin > 2 x upper limit of normal.
- •any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objectives.
- •any other investigational drug given within 30 days of initiation of therapy, and participation in other clinical studies while enrolled in this protocol.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Outcomes
Primary Outcomes
Compare the reduction in office BP following a 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan
Secondary Outcomes
- Compare the reduction in office BP following a 4-week regimen of irbesartan / hydrochlorothiazide versus irbesartan
- Compare the response rate (defined as office SBP/DBP reduce more than 10mmHg from week 0) of patients after 4-week and 8-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
- Compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
- Ascertain the safety and tolerability of irbesartan/hydrochlorothiazide versus irbesartan when administered once daily.
Investigators
Study Sites (1)
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