A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Essential Hypertension

Treatments: Drug: placebo; Drug: eplerenone; Drug: CS-3150

Study type: Interventional

Funder types: Industry

Identifiers

NCT02345044

CS3150-A-J203

Details and patient eligibility

About

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.

Enrollment: 426 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects aged 20 years or older at informed consent
• Subjects with essential hypertension (Sitting SBP ≥ 140 mmHg and < 180 mmHg, Sitting DBP ≥ 90 mmHg and < 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)

Exclusion criteria

• Secondary hypertension or malignant hypertension
• Diabetes mellitus with albuminuria
• Serum potassium level < 3.5 or ≥ 5.1 mEq/L
• Reversed day-night life cycle including overnight workers
• eGFR < 60 mL/min/1.73 m^2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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426 participants in 5 patient groups, including a placebo group

CS-3150 1.25 mg

Experimental group

Description:

One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.

Treatment:

Drug: placebo

Drug: CS-3150

CS-3150 2.5 mg

Experimental group

Description:

Two CS-3150 1.25 mg tablets administered orally, once daily after breakfast.

Treatment:

Drug: CS-3150

CS-3150 5 mg

Experimental group

Description:

Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast.

Treatment:

Drug: CS-3150

Placebo

Placebo Comparator group

Description:

Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.

Treatment:

Drug: placebo

Eplerenone, 50-100 mg (Open Label)

Active Comparator group

Description:

One or two 50mg eplerenone tablet(s) administered orally, once daily after breakfast.

Treatment:

Drug: eplerenone