Study of CS-3150 in Patients With Essential Hypertension

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: CS-3150; Drug: Eplerenone

• Registration Number: NCT02890173
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.

Detailed Description

Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.

Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-31
• Study Start: 2016-09
• Study First Posted: 2016-09-07
• Primary Completion: 2017-07-11
• Study Completion: 2017-07-11
• Status Verified: 2017-08
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1001

Inclusion Criteria

• Male and female subjects aged 20 years or older at informed consent

• Subjects with essential hypertension satisfying the following blood pressure criteria;

  • Sitting SBP: ≥ 140 mmHg and < 180 mmHg
  • Sitting DBP: ≥ 90 mmHg and < 110 mmHg
  • Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg

Exclusion Criteria

• Secondary hypertension or malignant hypertension
• Diabetic nephropathy or 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CS-3150 5.0 mg	CS-3150	CS-3150 5 mg, orally, once daily after breakfast for 12 weeks
CS-3150 2.5 mg	CS-3150	CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks
Eplerenone	Eplerenone	Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in sitting blood pressure	Baseline to end of Week 12	Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in 24 hour average blood pressure	Baseline to end of Week 12	Change from baseline in 24 hour average systolic and diastolic blood pressure.