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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00171119 |
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Date of registration:
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10/09/2005 |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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81 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00171119 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
35 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetic Nephropathy
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Hypertension
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Intervention(s)
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Drug: valsartan
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Primary Outcome(s)
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Change from baseline in urine albumin excretion rate after 24 weeks
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Secondary Outcome(s)
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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
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Percent of patients returning to normal urine albumin excretion rate after 24 weeks
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Secondary ID(s)
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CVAL489ATR05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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