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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02890173
Other study ID # CS3150-A-J301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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