Study of CS-3150 in Patients With Essential Hypertension

Essential Hypertension Clinical Trial

— ESAX-HTN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890173
• Other study ID #: CS3150-A-J301
• Status: Completed
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: July 11, 2017

Study information

• Verified date: August 2017
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1001
• Est. completion date: July 11, 2017
• Est. primary completion date: July 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• CS-3150

• Eplerenone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in sitting blood pressure	Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).	Baseline to end of Week 12
Secondary	Change from baseline in 24 hour average blood pressure	Change from baseline in 24 hour average systolic and diastolic blood pressure.	Baseline to end of Week 12