A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Amlodipine 5 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Monotherapy

Novartis12 sites in 1 country698 target enrollmentJanuary 2007

ConditionsHypertension

InterventionsValsartan/amlodipine 80/5 mg Amlodipine 5 mg

DrugsValsartan/amlodipine 80/5 mg Amlodipine 5 mg

Overview

Phase: Phase 3
Intervention: Valsartan/amlodipine 80/5 mg
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 698
Locations: 12
Primary Endpoint: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

November 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Valsartan/amlodipine 80/5 mg

Intervention: Valsartan/amlodipine 80/5 mg

Amlodipine 5 mg

Intervention: Amlodipine 5 mg

Outcomes

Primary Outcomes

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

Time Frame: Baseline to end of study (Week 8)

Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.

Secondary Outcomes

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)(Baseline to end of study (Week 8))
Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)(Baseline to end of study (Week 8))
Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)(Baseline to end of study (Week 8))
Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)(Baseline to end of study (Week 8))
Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)(Baseline to end of study (Week 8))