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Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension

NCT00500604 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1617

Last updated 2010-07-19

No results posted yet for this study

Summary

The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.

The secondary objectives are:

* To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24
* To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24
* To compare the difference in mean SBP evaluated by HBPM at week 16
* To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24
* To determine the incidence and severity of adverse events

Conditions

Interventions

DRUG

Irbesartan/hydrochlorothiazide

150/12.5mg tablet and 300/12.5mg tablet

DRUG

Valsartan/hydrochlorothiazide

80/12.5mg tablet and 160/12.5mg tablet

DRUG

Hydrochlorothiazide

12.5 mg administered orally, once daily in the morning

Sponsors & Collaborators

Principal Investigators

  • Benedict Blayney · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Egypt
  • Hong Kong
  • India
  • Indonesia
  • Malaysia
  • Morocco
  • Pakistan
  • Philippines
  • Singapore
  • South Korea
  • Taiwan
  • Thailand
  • Tunisia
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00500604 on ClinicalTrials.gov