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

NCT ID: NCT00171054

Last Updated: 2011-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2007-10-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Valsartan 320 mg

Group Type: EXPERIMENTAL

Valsartan 320 mg

Intervention Type: DRUG

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

Hydrochlorothiazide

Intervention Type: DRUG

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.

Amlodipine 10 mg

Group Type: EXPERIMENTAL

Amlodipine 10 mg

Intervention Type: DRUG

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

Hydrochlorothiazide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Pharmaceuticals

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

CVAL489A2418

Identifier Type: -

Identifier Source: org_study_id