Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug)

Phase: Phase 4

Status: No longer recruiting

Sponsored by: Novartis

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

The purpose of this study is compare treatment with valsartan with the possible addition of a diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment on the stiffness of the blood vessels will be studied.

Official title: A Randomized, Double-Blind, Parallel Group, Active-Controlled, 38-Week Study to Evaluate the Efficacy of Valsartan Versus Amlodipine on the Arterial Properties of Postmenopausal Women With Mild to Moderate Hypertension

Study design: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in blood measures of hypertension after 38 weeks

Secondary outcome:

Change from baseline in vascular sensitivity indices after 12 and 38 weeks

Change from baseline in heart size and function after 38 weeks

Minimum age: 50 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Postmenopausal women

- Mild to moderate hypertension

- Statin therapy or LDL≤ 4. 1 mmol/L

Exclusion Criteria:

- Severe hypertension

- LDL > 4. 1 mmol/L if not taking anti-hyperlipidemic medication

- Certain hormonal therapy

- History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm

- Liver, kidney, or pancreas disease

- Diabetes

- Raynaud’s disease or any other significant peripheral vascular disease

- Allergy to certain medications used to treat high blood pressure

Other protocol-defined inclusion/exclusion criteria may apply.

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: September 2003
Last updated: February 9, 2007