Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus
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
1 other identifier
interventional
392
0 countries
N/A
Brief Summary
This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2002
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedNovember 8, 2011
June 1, 2006
2.8 years
October 14, 2005
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in urinary protein excretion after 30 weeks
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- \- Mild to moderate hypertension, Mild renal dysfunction, Type 2 diabetes,
You may not qualify if:
- Pregnant or breast feeding, Type 1 diabetes
- Other protocol criteria apply
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Related Publications (2)
Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
PMID: 38682786DERIVEDWeir 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.
PMID: 19809363DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 18, 2005
Study Start
November 1, 2002
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
November 8, 2011
Record last verified: 2006-06