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ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

NCT00708344 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 832

Last updated 2010-07-16

No results posted yet for this study

Summary

To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.

Conditions

Interventions

DRUG

Irbesartan - Hydrochlorothiazide

150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Duration of treatment : 10 weeks

DRUG

Irbesartan - Hydrochlorothiazide

150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Treatment duration : 10 weeks

Sponsors & Collaborators

Principal Investigators

  • Nathalie - GENES, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Algeria
  • Argentina
  • Brazil
  • Colombia
  • Ecuador
  • Egypt
  • Guatemala
  • Lebanon
  • Mexico
  • Morocco
  • Panama
  • Peru
  • Saudi Arabia
  • Tunisia
  • United Arab Emirates
  • Venezuela

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 NCT00708344 on ClinicalTrials.gov