Phase 4
Completed N=125
Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension
Source: ClinicalTrials.gov NCT00171054 ↗Enrolled (actual)
125
Serious AEs
3.2%
Results posted
May 2011
Primary outcomePrimary: Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV) — -1.9; -1.7 m/s
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV) |
-1.9; -1.7 | — |
| SECONDARY Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12 |
25.4; -105.6 | — |
| SECONDARY Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38) |
-9.7; -94.6 | — |
| SECONDARY Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12 |
-8.7; -8.6 | — |
| SECONDARY 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) |
-8.1; -8.2 | — |
| SECONDARY Changes in Mean Left Carotid Distensibility at Week 12 |
0.0; 0.0 | — |
| SECONDARY Changes in Mean Left Carotid Distensibility at Week 38 |
0.0; 0.1 | — |
| SECONDARY Changes in Mean Right Carotid Distensibility at Week 12 |
-0.4; 0.1 | — |
| SECONDARY Changes in Mean Right Carotid Distensibility at Week 38 |
-0.2; 0.0 | — |
| SECONDARY Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12 |
1.5; -1.5 | — |
| SECONDARY Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38 |
-2.0; 0.1 | — |
| SECONDARY Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38 |
-4.8; -6.2 | — |
| SECONDARY Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38 |
-9.1; -14.2; -11.1; -13.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00171054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.