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Clinical Trials/JPRN-jRCT2080223293
JPRN-jRCT2080223293CompletedPhase 3

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

DAIICHI SANKYO Co.,Ltd.0 sites1,001 target enrollmentStarted: August 17, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,001
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

CS-3150 was administrated once daily for 12 weeks to patients with essential hypertension. The change in sitting blood pressure as the primary efficacy endpoint, was evaluated. The non-inferiority of CS-3150 2.5 mg to eplerenone 50 mg was verified, and the antihypertensive effect of CS-3150 5 mg was statistically significantly superior to that of 2. 5 mg. The incidence of adverse events was similar between 2.5 mg and 5 mg of CS-3150 and 50-mg of eplerenone.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to ot applicable (—)
Sex
All

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 < 180 mmHg, DBP >= 90 mmHg and < 110 mmHg
  • •-Mean 24 hr BP: SBP >= 130 and DBP >= 80 mmHg

Exclusion Criteria

  • •1)Secondary hypertension or malignant hypertension
  • •2)Diabetic nephropathy or diabetes mellitus with albuminuria
  • •3)Serum potassium level < 3.5 or >= 5.1 mEq/L
  • •4)Reversed day-night life cycle including overnight workers
  • •5)eGFR < 60 mL/min/1.73 m^2.

Investigators

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