Study of CS-3150 in Patients With Primary Aldosteronism

• Sponsor: Daiichi Sankyo Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02885662
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arm: 1
• Duration (Months): 10.6
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.

Condition or Disease	Intervention/Treatment	Phase
Primary Aldosteronism	Drug: CS-3150	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of CS-3150 to Evaluate Efficacy and Safety in Patients With Primary Aldosteronism
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jul 20, 2017
• Actual Study Completion Date: Jul 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CS-3150 CS-3150 2.5 to 5.0 mg , orally, once daily after breakfast for 12 weeks.	Drug: CS-3150; CS-3150 2.5 to 5.0 mg , orally.

Outcome Measures

Primary Outcome Measures

1. Change from baseline in sitting blood pressure [Baseline to end of Week 12]

   Change from baseline in sitting systolic and diastolic blood pressure

Secondary Outcome Measures

1. Time course of sitting blood pressure [Baseline to end of Week 12]

   Time course of sitting systolic and diastolic blood pressure

2. Proportion of patients achieving sitting blood pressure goal [Baseline to end of Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital	Yokohama	Kanagawa	Japan	222-0036

Sponsors and Collaborators

• Daiichi Sankyo Co., Ltd.

Investigators

• Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02885662
• Other Study ID Numbers: CS3150-A-J307
• First Posted: Aug 31, 2016
• Last Update Posted: Dec 21, 2018
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Daiichi Sankyo Co., Ltd.: Primary aldosteronism; Hypertension; mineralocorticoid receptor antagonist; Developmental Phase III
• Additional relevant MeSH terms: Hyperaldosteronism

Study Results

No Results Posted as of Dec 21, 2018