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

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
aliskiren
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetic Nephropathy focused on measuring diabetes, nephropathy, hypertension, aliskiren, losartan

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hypertension Elevated urinary protein levels Confirmed type 2 diabetes Exclusion Criteria: Certain diseases Uncontrolled diabetes Type 1 diabetes

Sites / Locations

  • Novartis Pharmaceuticals
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site

Outcomes

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

Full Information

First Posted
December 1, 2004
Last Updated
May 15, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00097955
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
diabetes, nephropathy, hypertension, aliskiren, losartan

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
496 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
aliskiren
Primary Outcome Measure Information:
Title
Change from baseline in urinary albumin creatinine ratio after 24 weeks
Secondary Outcome Measure Information:
Title
Equal/more than 50% reduction from baseline in urinary albumin creatinine ratio after 24 weeks
Title
Change from baseline in urinary albumin excretion rate after 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hypertension Elevated urinary protein levels Confirmed type 2 diabetes Exclusion Criteria: Certain diseases Uncontrolled diabetes Type 1 diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Facility Name
Investigative Site
City
Quebec
Country
Canada
Facility Name
Investigative Site
City
Hillerod
Country
Denmark
Facility Name
Investigative Site
City
Paris
Country
France
City
Investigative Centers
Country
Germany
Facility Name
Investigative Site
City
Athens
Country
Greece
Facility Name
Investigative Site
City
Rome
Country
Italy
Facility Name
Investigative Site
City
Rotterdam
Country
Netherlands
Facility Name
Investigative Site
City
Bucharest
Country
Romania
Facility Name
Investigative Site
City
Moscow
Country
Russian Federation
Facility Name
Investigative Site
City
Madrid
Country
Spain
Facility Name
Investigative Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20693353
Citation
Persson F, Lewis JB, Lewis EJ, Rossing P, Hollenberg NK, Parving HH; AVOID Study Investigators. Impact of baseline renal function on the efficacy and safety of aliskiren added to losartan in patients with type 2 diabetes and nephropathy. Diabetes Care. 2010 Nov;33(11):2304-9. doi: 10.2337/dc10-0833. Epub 2010 Aug 6.
Results Reference
derived
PubMed Identifier
18525041
Citation
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. doi: 10.1056/NEJMoa0708379.
Results Reference
derived

Learn more about this trial

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

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