A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

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

PHASE3

Total Enrollment

3790 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-01-31

Brief Summary

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The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of blood pressure reduction in a patient population of mild to moderate hypertensives

Detailed Description

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Conditions

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Hypertension

Keywords

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hypertension valsartan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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valsartan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* • Male or female age between 18-80 years of age, inclusive

* Diagnosed at enrollment (visits 2) to be mild to moderate hypertensive with a MSDBP \>= 95 and =\< 109 mmHg for non treated patients.
* Previously treated patients should have a MSDBP =\< 109 mmHg at visit 1 and a MSDBP \>= 95 and =\< 109 mmHg at visit 2.
* Written informed consent to participate in the study prior to any study procedures
* Ability to communicate and comply with all study requirements

Exclusion Criteria

* Severe hypertension (grade 3 of WHO classification; \>= 110 mmHg diastolic and/or \>= 180 mmHg systolic).
* Malignant hypertension
* Inability to discontinue all prior anti-hypertensive medications safely for a period of 2 weeks, as required by the protocol.
* Known history of proteinuria (greater than 0.3 gram per day)
* Female patients who are not either post-menopausal for one year or surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use is not allowed.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 1.
* Transient ischemic cerebral attack during the last 12 months prior to Visit 1.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceutical

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Investigative Centers, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CVAL489H2301

Identifier Type: -

Identifier Source: org_study_id