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

NCT00171054 | Completed Phase 4 Results

• 1 other identifier: CVAL489A2418
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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

Keywords

hypertension; postmenopausal; valsartan; amlodipine; hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)

  PWV was determined from transcutaneous Doppler flow recordings and the foot-to-foot method triggered by the simultaneous ECG. Two simultaneous Doppler flow tracings were taken at the left common carotid and the right femoral artery in the groin with a linear array probe. The time delay (t) was measured between R wave of the ECG and the base of the flow waves recorded at these points, and averaged over 10 beats. The distance (D) traveled by the pulse wave was measured over body surface as the distance from the suprasternal notch to the carotid artery. PWV was calculated as PWV=D/t.

  Baseline and Week 38

Secondary Outcomes (12)

• Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12

  Baseline and Week 12

• Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)

  Week 38

• Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12

  Baseline and Week 12

• 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)

  Baseline and Week 38

• Changes in Mean Left Carotid Distensibility at Week 12

  Baseline and Week 12

Study Arms (2)

Valsartan 320 mg

EXPERIMENTAL

Drug: Valsartan 320 mg; Drug: Hydrochlorothiazide

Amlodipine 10 mg

EXPERIMENTAL

Drug: Amlodipine 10 mg; Drug: Hydrochlorothiazide

Interventions

Valsartan 320 mg 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.

Valsartan 320 mg

Amlodipine 10 mg DRUG

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

Amlodipine 10 mg

Hydrochlorothiazide 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; Valsartan 320 mg

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women
• Mild to moderate hypertension
• Statin therapy or LDL≤ 4.1 mmol/L

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

Basel, Switzerland

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Amlodipine; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Dihydropyridines; Pyridines; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2003
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: June 6, 2011
• Results First Posted: May 3, 2011

Record last verified: 2011-06

Locations

CH (1)