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A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN study)

A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN study)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223293
Enrollment
930
Registered
2016-08-17
Start date
2016-09-23
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

Sponsors

DAIICHI SANKYO Co.,Ltd.
Lead Sponsor

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 and satisfied the following blood pressure criteria during run-in period; -Sitting BP: SBP >= 140 mmHg and = 90 mmHg and = 130 and DBP >= 80 mmHg

Exclusion criteria

Exclusion criteria: 1)Secondary hypertension or malignant hypertension 2)Diabetic nephropathy or diabetes mellitus with albuminuria 3)Serum potassium level = 5.1 mEq/L 4)Reversed day-night life cycle including overnight workers 5)eGFR < 60 mL/min/1.73 m^2.

Design outcomes

Primary

MeasureTime frame
efficacy safety - Change from baseline in sitting systolic and diastolic blood pressure - Adverse events

Secondary

MeasureTime frame
efficacy Change from baseline in 24 hr systolic and diastolic blood pressure

Countries

Japan

Outcome results

None listed

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