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

NCT00171054 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2011-06-06

Study results available
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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.

Conditions

Interventions

DRUG

Valsartan 320 mg

Patients received 160 mg valsartan for 4 weeks. Patients were then up-titrated to receive either 320 mg valsartan for the following 8 weeks.

DRUG

Amlodipine 10 mg

Patients received 5 mg amlodipine for four weeks. Patients were then up-titrated to receive 10 mg amlodipine for the following 8 weeks.

DRUG

Hydrochlorothiazide

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00171054 on ClinicalTrials.gov