At a glance
ClinicalIndex Comparison Record- ✓Postmenopausal women
- ✓Mild to moderate hypertension
- ✓LDL ≤4.1 mmol/L or on statin therapy
- ✕Severe hypertension
- ✕LDL >4.1 mmol/L without anti-hyperlipidemic medication
- ✕History of stroke, myocardial infarction, heart failure, chest pain, or abnormal heart rhythm
- ✕Liver, kidney, or pancreatic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Valsartan 320 mg, Amlodipine 10 mg, and 1 other intervention for Hypertension. Completed, enrolled 125 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Patients received 160 mg valsartan for 4 weeks. Patients were then up-titrated to receive either 320 mg valsartan for the following 8 weeks.
Patients received 5 mg amlodipine for four weeks. Patients were then up-titrated to receive 10 mg amlodipine for the following 8 weeks.
At Week 12, patients who did not meet target Blood Pressure for both Systolic Blood Pressure \< 140 mmHg and Diastolic Blood Pressure \< 90 mmHg were eligible to receive 12.5 mg open-label Hydrochlorothiazide for the following 26 weeks.