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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00241085

Enrollment

392

Registered

2005-10-18

Start date

2002-11-30

Completion date

2005-08-31

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, PROTEINURIA, Type 2 Diabetes

Keywords

proteinuria, hypertension, valsartan, type 2 diabetes

Brief summary

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

Interventions

DRUGvalsartan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in urinary protein excretion after 30 weeks	—

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026