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

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis
• Treatments: Valsartan

Criteria

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.