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

NCT ID: NCT00241085

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-08-31

Brief Summary

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

Detailed Description

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Conditions

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PROTEINURIA Hypertension Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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valsartan

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

References

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Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

Reference Type DERIVED
PMID: 38682786 (View on PubMed)

Weir MR, Hollenberg NK, Zappe DH, Meng X, Parving HH, Viberti G, Remuzzi G. Antihypertensive effects of double the maximum dose of valsartan in African-American patients with type 2 diabetes mellitus and albuminuria. J Hypertens. 2010 Jan;28(1):186-93. doi: 10.1097/HJH.0b013e328332bd61.

Reference Type DERIVED
PMID: 19809363 (View on PubMed)

Other Identifiers

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CVAL489A2417

Identifier Type: -

Identifier Source: org_study_id