To Assess the Effects of Valsartan on Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT00550095
- Lead Sponsor
- Novartis
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 509
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)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 valsartan valsartan
- Primary Outcome Measures
Name Time Method Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks. Week 24
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Investigative Site ,
🇪🇬Cairo, Egypt