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

Novartis

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: valsartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00241137

CVAL489H2301

Details and patient eligibility

About

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

Enrollment

3,790 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.