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

Study 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.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: CS-3150
* Drug: placebo
* Drug: eplerenone


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS-3150 1.25 mg<br>One CS-3150 1.25 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast. | Drug: CS-3150<br> <br> Drug: placebo<br> <br> |
| Experimental: CS-3150 2.5 mg<br>Two CS-3150 1.25 mg tablets administered orally, once daily after breakfast. | Drug: CS-3150<br> <br> |
| Experimental: CS-3150 5 mg<br>Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast. | Drug: CS-3150<br> <br> |
| Placebo Comparator: Placebo<br>Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast. | Drug: placebo<br> <br> |
| Active Comparator: Eplerenone, 50-100 mg (Open Label)<br>One or two 50mg eplerenone tablet(s) administered orally, once daily after breakfast. | Drug: eplerenone<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting systolic and diastolic blood pressure |  | baseline to end week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 24-hr blood pressure (ABPM) |  | Baseline to end week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential hypertension, mineralocorticoid receptor antagonist, CS-3150, Japanese