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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00670566
Recruitment Status : Completed
First Posted : May 2, 2008
Last Update Posted : September 15, 2009
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Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension Drug: irbesartan/hydrochlorothiazide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 503 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Study Start Date : April 2008
Actual Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00670566

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

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Responsible Party: Medical Affairs Study Director, Sanofi-aventis Identifier: NCT00670566     History of Changes
Other Study ID Numbers: IRBEH_L_03170
First Posted: May 2, 2008    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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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