At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 577 enrolled
Drug / intervention
olmesartan medoxomil +1 moredrug
Likely dose
Olmesartan medoxomil 10-40 mg orally once dailyAI-extracted
Key inclusion· 4
- ✓Clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes
- ✓Albumin-to-creatinine ratio ≥300 mg/g creatinine in first morning urinalysis (overt proteinuria)
- ✓Serum creatinine 1.0-2.5 mg/dL in women
- ✓Serum creatinine 1.2-2.5 mg/dL in men
Key exclusion· 12
- ✕Type 1 diabetes
- ✕Non-diabetic nephropathy
- ✕Myocardial infarction or coronary artery bypass grafting within 3 months
- ✕Percutaneous coronary intervention (PCI) within 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CS-866DM Phase 3 Clinical Study: A Double-Blind Controlled Trial in Patients With Diabetic Nephropathy and Overt Proteinuria Secondary to Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating olmesartan medoxomil and Placebo Tablets for Diabetic Nephropathy and 2 related conditions. Completed, enrolled 577 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Nephropathy, Type 2 Diabetes Mellitus, Proteinuria
CountriesChina, Japan
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2003
First PostedSep 2005
Primary CompletionAug 2008
Study CompletionJan 2009
TodayJul 2026
First PostedSep 1, 2005
Enrollment StartApr 1, 2003
Primary CompletionAug 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.8 years ago
Interventions
olmesartan medoxomildrug
Tablets 10, 20, or 40 mg
Placebo Tabletsdrug
Matching placebo tablets