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

Phase 4CompletedNCT00241085

Novartis392 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

392

Conditions

PROTEINURIA Hypertension Type 2 Diabetes

Interventions

valsartanDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in urinary protein excretion after 30 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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