A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients

Phase 3

Completed

• Conditions: Diabetes; Hypertension

• Registration Number: NCT00219102
• Lead Sponsor: Novartis

Brief Summary

To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2011-02
• Last Update Submitted: 2020-02-08
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

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 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in systolic blood pressure after 12 weeks
Change from baseline in systolic and diastolic blood pressure after 6 weeks
Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks
Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks

Trial Locations

Locations (2)

Investigative Site; 🇺🇦 Kiev, Ukraine

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland