| Trial ID: | L5858 |
| Source ID: | NCT00464776
|
| Associated Drug: |
Aliskiren
|
| Title: |
Study to Assess the Optimal Renoprotective Dose of Aliskiren in Hypertensive Patients With Type 2 Diabetes and Incipient or Overt Nephropathy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Aliskiren|DRUG: Aliskiren|DRUG: Aliskiren|DRUG: Aliskiren
|
| Outcome Measures: |
Primary: Investigate the antiproteinuric effect of increasing doses of Aliskiren compared to matching placebo., End of study | Secondary: Assess the effect on Glomerular Filtration Rate (GFR) of multiple dose administration of Aliskiren., End of study|Assess the effect on blood pressure of multiple dose administration of Aliskiren., End of study|To investigate whether there is a change in biomarkers of inflammation and cardiovascular risk., End of study
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
26
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-10
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2011-02-04
|
| Locations: |
Novartis, Gentofte, 2820, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT00464776
|
