Study of CS-3150 in Patients With Primary Aldosteronism

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

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

Study Overview

• Status: Completed
• Conditions: Primary Aldosteronism
• Intervention / Treatment: Drug: CS-3150

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 222-0036
      • Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in sitting blood pressure	Change from baseline in sitting systolic and diastolic blood pressure	Baseline to end of Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time course of sitting blood pressure	Time course of sitting systolic and diastolic blood pressure	Baseline to end of Week 12
Proportion of patients achieving sitting blood pressure goal		Baseline to end of Week 12

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): July 20, 2017

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Hypertension; mineralocorticoid receptor antagonist; Primary aldosteronism; Developmental Phase III
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: CS3150-A-J307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code