| Trial ID: | L7131 |
| Source ID: | NCT00141453
|
| Associated Drug: |
Olmesartan Medoxomil
|
| Title: |
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00141453/results
|
| Conditions: |
Diabetic Nephropathy|Type 2 Diabetes Mellitus|Proteinuria
|
| Interventions: |
DRUG: olmesartan medoxomil|DRUG: Placebo Tablets
|
| Outcome Measures: |
Primary: Renal Composite Outcomes, first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease, Randomization to 5 years | Secondary: Number of Participants Experiencing Cardiovascular Composite Outcomes, Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization., Within 5 years|The Change in Proteinuria, The median percentage change from baseline value in urinary protein:creatinine ratio, Randomization to 5 years|Reciprocal (1/Serum Creatinine) of Serum Creatinine, The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study., Randomization to 5 years
|
| Sponsor/Collaborators: |
Sponsor: Daiichi Sankyo Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
577
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2003-04
|
| Completion Date: |
2009-01
|
| Results First Posted: |
2011-05-10
|
| Last Update Posted: |
2011-05-10
|
| Locations: |
Hong Kong, China|Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00141453
|
