A Double-blind, Randomized, Multicenter Study to Evaluate the Effectiveness of the Combination of Valsartan & Amlodipine in Hypertensive Patients Not Controlled on Monotherapy

Novartis1 site in 1 country894 target enrollmentMarch 2006

ConditionsHypertension

Drugsvalsartan hydrochlorothiazide amlodipine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 894
Locations: 1
Primary Endpoint: Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 16 weeks
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

January 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 16 weeks

Secondary Outcomes

Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 8 weeks.
Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 4, 12, and 16 weeks.
Change from baseline diastolic and systolic blood pressure measurements after 4, 8, 12, and 16 weeks
Diastolic blood pressure less than 90 mmHg in non-diabetic patients and diastolic blood pressure less than 80 mmHg in diabetic patients after 4, 8, 12, and 16 weeks