Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00670566
First received: April 30, 2008
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  Purpose

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
Hypertension
 Drug: irbesartan/hydrochlorothiazide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with controlled blood pressure [ Time Frame: At month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Throughout the study period ] [ Designated as safety issue: Yes ]
  • Systolic and Diastolic Blood Pressure [ Time Frame: At month 3 versus baseline ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670566

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

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00670566     History of Changes
Other Study ID Numbers: IRBEH_L_03170
Study First Received: April 30, 2008
Last Updated: September 14, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Irbesartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 17, 2013