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

Condition(s) targeted: Hypertension

Intervention: Valsartan 320 mg (Drug); Amlodipine 10 mg (Drug); Hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

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

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)

Secondary outcome:

Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12

Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)

Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12

Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at End-point (Week 38)

Changes in Mean Left Carotid Distensibility at Week 12

Changes in Mean Left Carotid Distensibility at Week 38

Changes in Mean Right Carotid Distensibility at Week 12

Changes in Mean Right Carotid Distensibility at Week 38

Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12

Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38

Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38

Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38

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: June 2, 2011