Status:
COMPLETED
Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Lead Sponsor:
Sanofi
Conditions:
Hypertension
Eligibility:
All Genders
20-70 years
Phase:
PHASE3
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 reducti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00263003
Start Date
June 1 2005
Last Update
December 7 2007
Active Locations (1)
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1
Sanofi-Aventis
Taipei, Taiwan