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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02885662
Other study ID # CS3150-A-J307
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date July 20, 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 examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date July 20, 2017
Est. primary completion date July 20, 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

- Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing

- Patients satisfying following blood pressure;

- sitting systolic blood pressure (SBP) = 140 mmHg and <180 mmHg

- sitting diastolic blood pressure (DBP) = 90 mmHg and <110 mmHg

Exclusion Criteria:

- Secondary hypertension except primary aldosteronism or hypertensive emergency

- Patients diagnosed diabetic nephropathy

- Patients with type 1 diabetes

- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2

- Serum potassium level < 3.0 or = 5.1 milliequivalent (mEq)/L

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CS-3150
CS-3150 2.5 to 5.0 mg , orally.

Locations

Country Name City State
Japan Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital Yokohama Kanagawa

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 and diastolic blood pressure Baseline to end of Week 12
Secondary Time course of sitting blood pressure Time course of sitting systolic and diastolic blood pressure Baseline to end of Week 12
Secondary Proportion of patients achieving sitting blood pressure goal Baseline to end of Week 12
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