Study of CS-3150 in Patients With Primary Aldosteronism

Primary Aldosteronism Clinical Trial

Official title:

A Study of CS-3150 to Evaluate Efficacy and Safety in Patients With Primary Aldosteronism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885662
• Other study ID #: CS3150-A-J307
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

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