| Trial ID: | L5370 |
| Source ID: | NCT00185159
|
| Associated Drug: |
Olmesartan Medoxomil
|
| Title: |
Olmesartan Medoxomil in Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Cardiovascular Disease|Kidney Disease
|
| Interventions: |
DRUG: Olmesartan medoxomil|DRUG: Placebo Tablets
|
| Outcome Measures: |
Primary: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine, Time to the first occurrence | Secondary: Incidence of cardiovascular mortality and morbidity, Time to occurence|Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis), Time to occurrence|Occurrence and progression of retinopathy, Time to occurence|Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease, Time to occurrence|Safety and tolerability, Throughout entire study
|
| Sponsor/Collaborators: |
Sponsor: Sankyo Pharma Gmbh
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
4449
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2004-10
|
| Completion Date: |
2009-07
|
| Results First Posted: |
|
| Last Update Posted: |
2010-01-20
|
| Locations: |
Darmstadt, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00185159
|
