Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus
Information source: Novartis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Proteinuria; Hypertension; Type 2 Diabetes
Intervention: valsartan (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
Summary
This is a study of whether valsartan affects levels of proteinuria in patients with type 2
diabetes and hypertension.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: Change from baseline in urinary protein excretion after 30 weeks
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Last updated: June 1, 2006
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