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

Study Overview
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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.

Official Title
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A 24 Week, Multi-centre, Open Label, Non Controlled Study to Assess the Efficacy of Valsartan in Reducing Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus

Conditions
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Microalbuminuria, Proteinuria

Intervention / Treatment
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* Drug: valsartan


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>valsartan | Drug: valsartan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks. |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction of (BP) at 24 weeks compared to baseline level. Percent of patients whose BP is controlled at 24 weeks (< 130/80) |  | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microalbuminuria/proteinuria, hypertensive patients with type 2 diabetes, Valsartan, microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes