Status:
TERMINATED
A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Diabetic Nephropathy
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.
Eligibility Criteria
Inclusion
- male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria
- patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry
- patients who give written, signed, informed consent.
- patients with/without mild /moderate hypertension.
- patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment.
- patients without any accompanying systemic disease
Exclusion
- pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception
- patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00171119
Start Date
January 1 2004
Last Update
December 17 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Pharmaceuticals
Basel, Switzerland