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Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults

NCT00439738 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2017-05-16

Study results available
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Summary

The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure \[MSSBP\] \>150 mmHg) patients.

Conditions

Interventions

DRUG

HCTZ + Amlodipine

* 12.5 mg HCTZ capsules * 25 mg HCTZ capsules * 5 mg amlodipine capsules * 10 mg amlodipine capsules

DRUG

Valsartan/HCTZ

* 160 mg film-coated valsartan tablets * 320 mg film-coated valsartan tablets * 12.5 mg HCTZ capsules * 25 mg HCTZ capsules

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-11-30

Countries

  • United States

Study Locations

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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 NCT00439738 on ClinicalTrials.gov