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

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

Completed

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Key information

Conditions

Proteinuria Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsartan

Drug

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2005
First posted: Oct 18, 2005
Registry last updated: Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed