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

Novartis

Status and phase

Completed

Phase 4

Conditions

Proteinuria

Microalbuminuria

Treatments

Drug: valsartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00550095

CVAL489AEG03

Details and patient eligibility

About

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.

Enrollment

509 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)