A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00219193
• Lead Sponsor: Novartis

Brief Summary

To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Study Start: 2005-10
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 641

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in standing blood pressure after 4 weeks and 8 weeks
Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks
Achieve blood pressure control target of < 140/90 mmHg after 8 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States