Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

• Status: Completed
• Trial end date: 2017-05-15
• 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 moderate renal impairment.

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

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Mineralocorticoid Receptor Antagonists

Criteria

Inclusion Criteria:

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

• 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/1.73 m2 and < 60 mL/min/1.73 m2

Exclusion Criteria:

• Secondary hypertension or malignant hypertension

• Diabetes mellitus with albuminuria

• Subjects under Insulin treatment

• Subjects under or pre-planned for hemodialysis

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