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

Phase 2

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: CS-3150; Drug: placebo; Drug: eplerenone

• Registration Number: NCT02345044
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-26
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CS-3150 1.25 mg	CS-3150	One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Placebo	placebo	Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.
CS-3150 1.25 mg	placebo	One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
CS-3150 5 mg	CS-3150	Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast.
CS-3150 2.5 mg	CS-3150	Two CS-3150 1.25 mg tablets administered orally, once daily after breakfast.
Eplerenone, 50-100 mg (Open Label)	eplerenone	One or two 50mg eplerenone tablet(s) administered orally, once daily after breakfast.

Primary Outcome Measures

Name	Time	Method
Change from baseline in sitting systolic and diastolic blood pressure	baseline to end week 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline in 24-hr blood pressure (ABPM)	Baseline to end week 12