NCT00141453CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Enrollment
- 577
- Primary Endpoint
- Renal Composite Outcomes
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes
- •albumin-to-creatinine ratio >= 300 mg/g creatinine in first morning urinalysis
- •serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men
Exclusion Criteria
- •type 1 diabetes
- •non-diabetic nephropathy
- •history of myocardial infarction
- •history of cardiac bypass grafting within 3 months
- •history of percutaneous coronary intervention (PCI) within 6 months
- •history of carotid artery or peripheral artery revascularization within 6 months
- •stroke or transient ischemic attack (TIA) within 1 year
- •unstable angina pectoris
- •heart failure of NYHA functional classes III or IV
- •rapid progression of kidney disease within 3 months
- •severe orthostatic hypotension
- •serum potassium level =<3.5 mEq(mmol)/L or =>5.5 mEq(mmol)L
- •history of rapid elevation of the serum creatinine level after starting treatment with AII receptor antagonists or ACE inhibitors
- •poor glycemic control: HbA1c level =>11%
- •history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months
Arms & Interventions
1
Experimental
Olmesartan medoxomil tablets 10mg to 40 mg
Intervention: olmesartan medoxomil (Drug)
2
Placebo Comparator
Matching placebo tablets
Intervention: Placebo Tablets (Drug)
Outcomes
Primary Outcomes
Renal Composite Outcomes
Time Frame: Randomization to 5 years
first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease
Secondary Outcomes
- Number of Participants Experiencing Cardiovascular Composite Outcomes(Within 5 years)
- The Change in Proteinuria(Randomization to 5 years)
- Reciprocal (1/Serum Creatinine) of Serum Creatinine(Randomization to 5 years)
Investigators
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