Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and Albuminuria

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Mineralocorticoid Receptor Antagonists

Criteria

Inclusion Criteria:

• Male and female subjects aged 20 to 80 years at informed consent

• Subjects with type 2 diabetes and albuminuria (urine albumin-to-creatinine ratio ≥ 30, < 1000 mg/g/Cr)

• Subjects with hypertension (Sitting SBP ≥ 140 mmHg, <180 mmHg and Sitting DBP ≥ 80 mmHg, <110 mmHg

• Treatment with an ARB or ACE inhibitor

• eGFR ≥ 30 mL/min/1.73m^2

Exclusion Criteria:

• Secondary hypertension or malignant hypertension

• Type 1 diabetes

• Secondary glucose intolerance

• Diagnosed with non-diabetic nephropathy

• Serum potassium level < 3.5 or ≥ 4.8 mEq/L