To Assess the Effects of Valsartan on Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus

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

509 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-11-30

Brief Summary

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This study is designed to assess the efficacy of the different dosage forms of Valsartan\[80, 160, and 320 mg\] in reducing microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes.

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Detailed Description

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Conditions

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Microalbuminuria Proteinuria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

valsartan

Group Type EXPERIMENTAL

valsartan

Intervention Type DRUG

Interventions

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valsartan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females aged 35 to 75.
* Type 2 diabetes mellitus (DM) patients coupled with hypertension \[sitting systolic blood pressure (SSBP) 140-179 mm Hg and/or SDBP 90-109 mm Hg\].
* Urinary albumin creatinine Ratio (UACR)) indicating microalbuminuria/proteinuria \[30-1000 mg/g or 2.5-25 mg/mmol\]
* Body mass index (BMI) \<40 kg/m2
* Patients who will sign an informed consent.

Exclusion Criteria

* Type 1 DM
* All causes of secondary diabetes mellitus
* Women of childbearing potential who refuse to use contraception.
* Pregnant or lactating females.
* Severe hypertension \[SSBP\> 180 mmHg, sitting diastolic blood pressure (SDBP) \> 110 mmHg \]
* Patients who are on combo therapy to control BP
* Patients who are already on Valsartan.
* Hypersensitivity to Valsartan.
* Renal artery stenosis \[ unilateral or bilateral\]
* Patients taking β blockers, (Angiotensin Converting Enzyme Inhibitor (ACEI) or spironolactone
* Heart Failure
* History of myocardial infarction, Percutaneous Transluminal Coronary Angioplasty(PTCA) or cerebrovascular accident within the preceding 3 months.
* Creatinine levels \> 1.4 mg/dl \[ 0.07mmol/l\]. Liver enzymes \> 2 times Upper Limit of the Normal Range(ULN). Diabetic keto-acidosis (DKA) within the last 6 months. Presence of diabetic neuropathy or retinopathy. Diabetic foot complications. Presence of infection at time of screening. Hyperkalemia (serum K+ \> 5.5 mmol/L)

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No