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

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceutical, Study Director, Affiliation: Novartis

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

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Primary outcome: Change from baseline diastolic blood pressure after 4 weeks

Secondary outcome:

Change from baseline systolic blood pressure after 4 weeks

Change from baseline diastolic and systolic blood pressure in patients with a diastolic blood pressure greater than or equal to 90 mmHg at randomization after 4 weeks

Adverse events and serious adverse events at each study visit for 4 weeks

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Investigative Centers, Germany

Last updated: November 13, 2006