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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Hypertension With Moderate Renal Impairment

Treatments: Drug: CS-3150

Study type: Interventional

Funder types: Industry

Identifiers

NCT02807987

CS3150-A-J305

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

CS-3150

Experimental group

Description:

CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks

Treatment:

Drug: CS-3150