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.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00097955
First received: December 1, 2004
Last updated: February 24, 2011
Last verified: February 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:


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
Estimated Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Canada
Investigative Site
Quebec, Canada
Denmark
Investigative Site
Hillerod, Denmark
France
Investigative Site
Paris, France
Germany
Investigative Centers, Germany
Greece
Investigative Site
Athens, Greece
Italy
Investigative Site
Rome, Italy
Netherlands
Investigative Site
Rotterdam, Netherlands
Romania
Investigative Site
Bucharest, Romania
Russian Federation
Investigative Site
Moscow, Russian Federation
Spain
Investigative Site
Madrid, Spain
United Kingdom
Investigative Site
London, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00097955     History of Changes
Obsolete Identifiers: NCT00219206
Other Study ID Numbers: CSPP100C2201
Study First Received: December 1, 2004
Last Updated: February 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
diabetes
nephropathy
hypertension
aliskiren
losartan

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Hypertension
Kidney Diseases
Proteinuria
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Vascular Diseases
Cardiovascular Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Antihypertensive Agents
Losartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014