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NCT00241085 Clinical Trial

Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00241085
Other study ID # CVAL489A2417
Secondary ID
Status Completed
Phase Phase 4
First received October 14, 2005
Last updated November 7, 2011
Start date November 2002
Est. completion date August 2005

Study information
Verified date June 2006
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 392
Est. completion date August 2005
Est. primary completion date August 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• valsartan

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in urinary protein excretion after 30 weeks
Secondary 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
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