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Main
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Note: This record shows only 22 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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16 December 2017 |
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Main ID: |
NCT00097955 |
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Date of registration:
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01/12/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria
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Scientific title:
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Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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496 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00097955 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double.
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Denmark
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France
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Germany
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Greece
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Italy
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Netherlands
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Romania
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Russian Federation
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Spain
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United Kingdom
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United States
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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:
- Hypertension
- Elevated urinary protein levels
- Confirmed type 2 diabetes
Exclusion Criteria:
- Certain diseases
- Uncontrolled diabetes
- Type 1 diabetes
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetic Nephropathy
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Intervention(s)
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Drug: aliskiren
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Primary Outcome(s)
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Change from baseline in urinary albumin creatinine ratio after 24 weeks
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Secondary Outcome(s)
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Change from baseline in urinary albumin excretion rate after 24 weeks
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Equal/more than 50% reduction from baseline in urinary albumin creatinine ratio after 24 weeks
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Secondary ID(s)
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CSPP100C2201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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