A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: CS-3150

Study type: Interventional

Funder types: Industry

Identifiers

NCT02448628

CS3150-A-J206

Details and patient eligibility

About

This study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.

Enrollment: 33 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women Aged 20 years or older and 80 years or younger at informed consent
• Subjects with hypertension (Sitting systolic blood pressure SBP >= 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP >= 80 mmHg and < 110 mmHg)
• estimated glomerular filtration rate 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
• Serum potassium level < 3.5 or >= 5.1 mEq/L
• Subjects under Insulin treatment
• Subjects under or pre-planned for hemodialysis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

CS-3150

Experimental group

Description:

CS-3150 1.25 to 5.0 mg , orally, once daily after breakfast for 12 weeks

Treatment:

Drug: CS-3150