Back to resultsEffect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus
Primary Purpose
PROTEINURIA, Hypertension, Type 2 Diabetes
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
valsartan
Sponsored by
About this trial
This is an interventional treatment trial for PROTEINURIA focused on measuring proteinuria, hypertension, valsartan, type 2 diabetes
Eligibility Criteria
Inclusion Criteria: - Mild to moderate hypertension, Mild renal dysfunction, Type 2 diabetes, Exclusion Criteria: Pregnant or breast feeding, Type 1 diabetes Other protocol criteria apply
Sites / Locations
Outcomes
Primary Outcome Measures
Change from baseline in urinary protein excretion after 30 weeks
Secondary Outcome Measures
Change from baseline in circulating markers of blood vessel inflammation, insulin resistance, serum creatinine, diabetic control, and proportion of patients who return to normalization of protein excretion after 30 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00241085
Brief Title
Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus
Official Title
A Multi-center, Double Blind, Randomized, Parallel Group Study to Evaluate the Effects of Valsartan on Proteinuria in Hypertensive Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PROTEINURIA, Hypertension, Type 2 Diabetes
Keywords
proteinuria, hypertension, valsartan, type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
392 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valsartan
Primary Outcome Measure Information:
Title
Change from baseline in urinary protein excretion after 30 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in circulating markers of blood vessel inflammation, insulin resistance, serum creatinine, diabetic control, and proportion of patients who return to normalization of protein excretion after 30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate hypertension, Mild renal dysfunction, Type 2 diabetes,
Exclusion Criteria:
Pregnant or breast feeding, Type 1 diabetes
Other protocol criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19809363
Citation
Weir MR, Hollenberg NK, Zappe DH, Meng X, Parving HH, Viberti G, Remuzzi G. Antihypertensive effects of double the maximum dose of valsartan in African-American patients with type 2 diabetes mellitus and albuminuria. J Hypertens. 2010 Jan;28(1):186-93. doi: 10.1097/HJH.0b013e328332bd61.
Results Reference
derived
Learn more about this trial
Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus
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