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
1 other identifier
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedDecember 17, 2008
December 1, 2008
1.2 years
September 10, 2005
December 16, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in urine albumin excretion rate after 24 weeks
Secondary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Pharmaceuticals
Basel, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 15, 2005
Study Start
January 1, 2004
Primary Completion
March 1, 2005
Last Updated
December 17, 2008
Record last verified: 2008-12