A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Hypertension
Overview
- Phase
- Phase 2
- Intervention
- CS-3150
- Conditions
- Essential Hypertension
- Sponsor
- Daiichi Sankyo
- Enrollment
- 426
- Primary Endpoint
- Change from baseline in sitting systolic and diastolic blood pressure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
CS-3150 1.25 mg
One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Intervention: CS-3150
CS-3150 1.25 mg
One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Intervention: placebo
CS-3150 2.5 mg
Two CS-3150 1.25 mg tablets administered orally, once daily after breakfast.
Intervention: CS-3150
CS-3150 5 mg
Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast.
Intervention: CS-3150
Placebo
Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.
Intervention: placebo
Eplerenone, 50-100 mg (Open Label)
One or two 50mg eplerenone tablet(s) administered orally, once daily after breakfast.
Intervention: eplerenone
Outcomes
Primary Outcomes
Change from baseline in sitting systolic and diastolic blood pressure
Time Frame: baseline to end week 12
Secondary Outcomes
- Change from baseline in 24-hr blood pressure (ABPM)(Baseline to end week 12)