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

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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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

509 participants in 1 patient group

1
Experimental group
Description:
valsartan
Treatment:
Drug: valsartan

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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