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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02345044

Enrollment

426

Registered

2015-01-26

Start date

2015-01-31

Completion date

2015-10-31

Last updated

2019-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

Essential hypertension, mineralocorticoid receptor antagonist, CS-3150, Japanese

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.

Interventions

DRUGCS-3150

DRUGplacebo

DRUGeplerenone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in sitting systolic and diastolic blood pressure	baseline to end week 12

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026