Clinical trial NCT00171054: Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension
postmenopausal
valsartan
amlodipine
hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 125
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)
timeFrame: Baseline and Week 38
Secondary outcomes:
measure: Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)
timeFrame: Week 38
measure: Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12
timeFrame: Baseline and Week 12
measure: 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)
timeFrame: Baseline and Week 38
measure: Changes in Mean Left Carotid Distensibility at Week 12
timeFrame: Baseline and Week 12
measure: Changes in Mean Left Carotid Distensibility at Week 38
timeFrame: Baseline and Week 38
measure: Changes in Mean Right Carotid Distensibility at Week 12
timeFrame: Baseline and Week 12
measure: Changes in Mean Right Carotid Distensibility at Week 38
timeFrame: Baseline and Week 38
measure: Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38
timeFrame: Baseline and Week 38
measure: Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38
timeFrame: Baseline and Week 38
measure: Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38
timeFrame: Baseline, Week 12 and Week 38
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: