Primary objective: To evaluate the antihypertensive efficacy of a fixed combination of Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive patients Secondary objective: To get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive...
Date First Received: April 30, 2008
Last Updated: May 1, 2008
Verified by: Sanofi-Aventis, April 2008
Clinical Trial Phase: Phase 4 | Start Date: April 2008
Overall Status: Recruiting
Estimated Enrollment: 500
Brief Summary
Official Title: “Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate- to Severe Hypertensive Patients”
Condition Keyword(s):
Intervention(s):
Primary objective:
To evaluate the antihypertensive efficacy of a fixed combination of Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive patients
Secondary objective:
To get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive patients
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Study Primary Completion Date: June 2009
Intervention(s) in this Clinical Trial
- Drug: irbesartan/hydrochlorothiazide
- 50/12.5mg for 4 weeks follow 300/12.5mg for 4 weeks and proceed to 300/25mg for 4 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
Outcome Measures for this Clinical Trial
Primary Measures
- Number of patients with controlled blood pressure
- Time Frame: At 3 month
Safety Issue?: No
- Time Frame: At 3 month
Secondary Measures
- Adverse events
- Time Frame: Throughout the study period
Safety Issue?: Yes
- Time Frame: Throughout the study period
- Systolic and Diastolic Blood Pressure
- Time Frame: At month 3 versus baseline
Safety Issue?: No
- Time Frame: At month 3 versus baseline
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Essential hypertensive patients
- Moderate to severe Patients with uncontrolled blood pressure (systolic blood pressure
- ≥160mmHg, diastolic blood pressure ≥100mmHg for untreated, systolic blood pressure
- ≥150mmHg, diastolic blood pressure ≥95mmHg for treated on monotherapy).
- Patients are willing to discontinue previous antihypertensive medicine
Exclusion Criteria:
- Pregnant or lactating women, or women of child bearing potential without contraceptive method.
- Hypersensitivity to any component of the products or other sulfonamide derived substances.
- Secondary hypertension.
- Severe renal impairment (Creatinine Clearance ≤30ml/min)
- Severe hepatic impairment, biliary cirrhosis and cholestasis.
- Refractory hypokalemia, hypercalcaemia.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Sanofi-Aventis
Overall Clinical Trial Officials and Contacts
Mei Mao Study Director Sanofi-Aventis
Overall Contact: Public Registry GMA publicregistryGMA@sanofi-aventis.com
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00670566
Study ID Number: IRBEH_L_03170
ClinicalTrials.gov Identifier: NCT00670566
Health Authority: China: State Food and Drug Administration
Clinical Trials Authorship and Review
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