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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Valsartan

Criteria

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)