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Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: April 30, 2008
Last updated: September 14, 2009
Last verified: September 2009

The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive patients.

The secondary objective is to get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive patients.

Condition Intervention Phase
Drug: irbesartan/hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with controlled blood pressure [ Time Frame: At month 3 ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Throughout the study period ]
  • Systolic and Diastolic Blood Pressure [ Time Frame: At month 3 versus baseline ]

Enrollment: 503
Study Start Date: April 2008
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: irbesartan/hydrochlorothiazide
50/12.5mg for 4 weeks follow 300/12.5mg for 4 weeks and proceed to 300/25mg for 4 weeks
Other Name: CoAprovel


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00670566

Sanofi-Aventis Administrative Office
Shanghai, China
Sponsors and Collaborators
Study Director: Mei Mao Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, Sanofi-aventis Identifier: NCT00670566     History of Changes
Other Study ID Numbers: IRBEH_L_03170
Study First Received: April 30, 2008
Last Updated: September 14, 2009

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on April 28, 2017