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A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171119
First received: September 10, 2005
Last updated: December 16, 2008
Last verified: December 2008
History of Changes

September 10, 2005
December 16, 2008
January 2004
March 2005   (final data collection date for primary outcome measure)
Change from baseline in urine albumin excretion rate after 24 weeks
  • - To compare the short-term effects of valsartan,
  • benazepril and valsartan + benazepril on urinary
  • albumin excretion rate (UAER) in patients with type 2
  • diabetes and microalbuminuria.
Complete list of historical versions of study NCT00171119 on ClinicalTrials.gov Archive Site
  • Change from baseline in urine albumin excretion rate after 24 weeks in those patients with blood pressure greater than 140/90, or who had previously taken blood pressure medicine, at study entry
  • Percent of patients returning to normal urine albumin excretion rate after 24 weeks
  • - To compare the short-term effects of valsartan,
  • benazepril, and benazepril + od valsartan on UAER in
  • the hypertensive subset of patients.
  • - To compare the numbers of patients in each group who
  • returned to normoalbuminuric status after 24 weeks of
  • treatment.
  • - To assess patient compliance, safety, withdrawal rate
  • and reasons for withdrawal.
Not Provided
Not Provided
 
A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril
A 24-Week Study to Assess Blood Pressure Independent Effects of Valsartan Treatment, Benazepril Treatment and Combination of Both Valsartan and Benazepril Treatment on Urinary Albumin Excretion Rate With Type II Diabetes Mellitus and Microalbuminuria

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Diabetic Nephropathy
Drug: valsartan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
81
Not Provided
March 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
35 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00171119
CVAL489ATR05
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP