A Long-term Study of CS-3150 as monotherapy or in combination with other antihypertensive drug in Japanese Patients with Essential Hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223121

Enrollment

360

Registered

2016-03-01

Start date

2016-03-14

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Essential hypertension

Interventions

investigational material(s) Generic name etc : CS-3150 INN of investigational material : Esaxerenone Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational mat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Male and female subjects aged 20 years or older at informed consent 2) Subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, ACE inhibitor, or ARB during run-in period (Sitting SBP >= 140 mmHg and = 90 mmHg and = 130 and DBP >= 80 mmHg)

Exclusion criteria

Exclusion criteria: 1)Secondary hypertension or malignant hypertension 2)Diabetes mellitus with albuminuria 3)Serum potassium level = 5.1 mEq/L (>= 4.8 mEq/L if receive ACE inhibitor, or ARB) 4)Reversed day-night life cycle including overnight workers 5)eGFR < 60 mL/min/1.73 m^2.

Design outcomes

Primary

Measure	Time frame
efficacy safety -Change from baseline in sitting systolic and diastolic blood pressure (Baseline to end of Week 12, 28, 52) -Adverse events, laboratory abnormalities, vital signs	—

Secondary

Measure	Time frame
efficacy Change from baseline in 24-hr blood pressure (ABPM) (Baseline to end of Week 12, 28, 52)	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026