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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00097955

Collaborator

(none)

496

Enrollment

Locations

Duration (Months)

41.3

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathy	Drug: aliskiren	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Apr 1, 2007

Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Change from baseline in urinary albumin creatinine ratio after 24 weeks []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hypertension
Elevated urinary protein levels
Confirmed type 2 diabetes

Exclusion Criteria:

Certain diseases
Uncontrolled diabetes
Type 1 diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	East Hanover	New Jersey	United States	07936
2	Investigative Site	Quebec		Canada
3	Investigative Site	Hillerod		Denmark
4	Investigative Site	Paris		France
5		Investigative Centers		Germany
6	Investigative Site	Athens		Greece
7	Investigative Site	Rome		Italy
8	Investigative Site	Rotterdam		Netherlands
9	Investigative Site	Bucharest		Romania
10	Investigative Site	Moscow		Russian Federation
11	Investigative Site	Madrid		Spain
12	Investigative Site	London		United Kingdom