Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria
1 other identifier
interventional
496
12 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2004
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 1, 2004
CompletedFirst Posted
Study publicly available on registry
December 2, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMay 17, 2017
May 1, 2017
2.5 years
December 1, 2004
May 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in urinary albumin creatinine ratio after 24 weeks
Secondary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- Hypertension
- Elevated urinary protein levels
- Confirmed type 2 diabetes
You may not qualify if:
- Certain diseases
- Uncontrolled diabetes
- Type 1 diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Investigative Site
Québec, Canada
Investigative Site
Hillerød, Denmark
Investigative Site
Paris, France
Unknown Facility
Investigative Centers, Germany
Investigative Site
Athens, Greece
Investigative Site
Rome, Italy
Investigative Site
Rotterdam, Netherlands
Investigative Site
Bucharest, Romania
Investigative Site
Moscow, Russia
Investigative Site
Madrid, Spain
Investigative Site
London, United Kingdom
Related Publications (2)
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.
PMID: 20693353DERIVEDParving 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.
PMID: 18525041DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 1, 2004
First Posted
December 2, 2004
Study Start
October 1, 2004
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
May 17, 2017
Record last verified: 2017-05