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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie aliskiren's renin inhibition in diabetic nephropathy?
How does aliskiren compare to other RAAS inhibitors in managing proteinuria in type 2 diabetes patients?
Which biomarkers correlate with aliskiren response in hypertension and diabetic kidney disease?
What adverse events were observed when combining aliskiren with losartan in NCT00097955?
Are there alternative renin-angiotensin pathway combinations to aliskiren for treating proteinuric diabetic nephropathy?
Trial Locations
- Locations (2)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States
Investigative Site
🇬🇧London, United Kingdom
Novartis Pharmaceuticals🇺🇸East Hanover, New Jersey, United States