Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria

Phase 2

Completed

• Conditions: Diabetic Nephropathy

• Registration Number: NCT00097955
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Study of the efficacy and safety of aliskiren when added to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders to monitor improvement in any of these conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2004-12-01
• Study First Submitted QC: 2004-12-01
• Study First Posted: 2004-12-02
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 496

Inclusion Criteria

• Hypertension
• Elevated urinary protein levels
• Confirmed type 2 diabetes

Exclusion Criteria

• Certain diseases
• Uncontrolled diabetes
• Type 1 diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in urinary albumin creatinine ratio after 24 weeks

Secondary Outcome Measures

Name	Time	Method
Equal/more than 50% reduction from baseline in urinary albumin creatinine ratio after 24 weeks
Change from baseline in urinary albumin excretion rate after 24 weeks

Trial Locations

Locations (2)

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

Investigative Site; 🇬🇧 London, United Kingdom