A 28-week, Multicenter Study to Evaluate the Effects of Valsartan/Hydrochlorothiazide (160/12.5 mg) in Comparison With Hydrochlorothiazide (25 mg) Monotherapy, for the Treatment of Patients With Hypertension, Uncontrolled by Hydrochlorothiazide (12.5 mg) Monotherapy

Novartis1 site in 1 country300 target enrollmentNovember 2005

ConditionsHypertension

InterventionsValsartan/Hydrochlorothiazide HCTZ

DrugsValsartan/Hydrochlorothiazide HCTZ

Overview

Phase: Phase 4
Intervention: Valsartan/Hydrochlorothiazide
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 300
Locations: 1
Primary Endpoint: Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

November 2005

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•Male or female 18 years of age and older
•Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but \< 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and \<110 mm Hg

Exclusion Criteria

•- Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
•Diabetes with fasting glucose \> 126 mg/dl or on existing anti-diabetic medication
•History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure.
•Other protocol-defined inclusion/exclusion criteria may apply.