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

This study has been completed.

First Received: December 1, 2004 Last Updated: April 24, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00097955

Purpose

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	Intervention	Phase
Diabetic Nephropathy	Drug: aliskiren	Phase II

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines Diabetes Diabetic Kidney Problems High Blood Pressure

Drug Information available for: Losartan Losartan potassium Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment:	496
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hypertension
Elevated urinary protein levels
Confirmed type 2 diabetes

Exclusion Criteria:

Certain diseases
Uncontrolled diabetes
Type 1 diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097955

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	CSPP100C2201
Study First Received:	December 1, 2004
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00097955 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

diabetes
nephropathy
hypertension
aliskiren
losartan

Study placed in the following topic categories:

Losartan
Diabetic Nephropathies
Metabolic Diseases
Urination Disorders
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers

Signs and Symptoms
Proteinuria
Urologic Diseases
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Endocrinopathy
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Disorder
Diabetes Complications
Hypertension

Additional relevant MeSH terms:

Losartan
Diabetic Nephropathies
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers

Signs and Symptoms
Urological Manifestations
Proteinuria
Urologic Diseases
Therapeutic Uses
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Anti-Arrhythmia Agents
Kidney Diseases
Glucose Metabolism Disorders
Diabetes Complications
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009