Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

NCT ID: NCT00277472

Last Updated: 2011-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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valsartan HCTZ

Group Type EXPERIMENTAL

Valsartan/Hydrochlorothiazide

Intervention Type DRUG

160/12.5 mg taken once daily orally

HCTZ

Group Type ACTIVE_COMPARATOR

HCTZ

Intervention Type DRUG

25 mg taken once daily orally

Interventions

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Valsartan/Hydrochlorothiazide

160/12.5 mg taken once daily orally

Intervention Type DRUG

HCTZ

25 mg taken once daily orally

Intervention Type DRUG

Other Intervention Names

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Co-Diovan, Diovan HCT hydrochlorothiazice, water pill

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharma

Principal Investigators

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Novartis 862-778-8300 Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CVAH631BUS04

Identifier Type: -

Identifier Source: org_study_id

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