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Clinical Trials/NCT00670566
NCT00670566CompletedPhase 4

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

Sanofi1 site in 1 country503 target enrollmentStarted: April 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Sanofi
Enrollment
503
Locations
1
Primary Endpoint
Number of patients with controlled blood pressure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
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.

Arms & Interventions

1

Experimental

Intervention: irbesartan/hydrochlorothiazide (Drug)

Outcomes

Primary Outcomes

Number of patients with controlled blood pressure

Time Frame: At month 3

Secondary Outcomes

  • Adverse events(Throughout the study period)
  • Systolic and Diastolic Blood Pressure(At month 3 versus baseline)

Investigators

Sponsor
Sanofi
Sponsor Class
Industry

Study Sites (1)

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