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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 1, 2004

Last Updated Date

April 24, 2008

Start Date ^†

October 2004

Current Primary Outcome Measures ^†

Change from baseline in urinary albumin creatinine ratio after 24 weeks

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00097955 on ClinicalTrials.gov Archive Site

Current 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

Original 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

Descriptive Information

Brief Title ^†

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

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

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Diabetic Nephropathy

Intervention ^†

Drug: aliskiren

Study Arms / Comparison Groups

Publications *

Parving HH, Persson F, Lewis JB, Lewis EJ, Hollenberg NK; AVOID Study Investigators. Aliskiren combined with losartan in type 2 diabetes and nephropathy. N Engl J Med. 2008 Jun 5;358(23):2433-46.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

496

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Hypertension
Elevated urinary protein levels
Confirmed type 2 diabetes

Exclusion Criteria:

Certain diseases
Uncontrolled diabetes
Type 1 diabetes

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00097955

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.