| Trial ID: | L1163 |
| Source ID: | NCT01893242
|
| Associated Drug: |
Aleglitazar
|
| Title: |
A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)
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| Acronym: |
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| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2, Kidney Disease, Chronic
|
| Interventions: |
DRUG: Aleglitazar|DRUG: Placebo
|
| Outcome Measures: |
Primary: Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death, Approximately 5 years | Secondary: Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke), Approximately 5 years|Time to the first occurrence of any component of macrovascular composite (CV death, non fatal myocardial infarction, hospitalization for unstable angina, non fatal stroke), Approximately 5 years|Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality, Approximately 5 years
|
| Sponsor/Collaborators: |
Sponsor: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-12
|
| Completion Date: |
2019-01
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-02
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| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT01893242
|