search
Back to results

Study of CS-3150 in Patients With Primary Aldosteronism

Primary Purpose

Primary Aldosteronism

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
CS-3150
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Aldosteronism focused on measuring Primary aldosteronism, Hypertension, mineralocorticoid receptor antagonist, Developmental Phase III

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CS-3150

Arm Description

CS-3150 2.5 to 5.0 mg , orally, once daily after breakfast for 12 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in sitting blood pressure
Change from baseline in sitting systolic and diastolic blood pressure

Secondary Outcome Measures

Time course of sitting blood pressure
Time course of sitting systolic and diastolic blood pressure
Proportion of patients achieving sitting blood pressure goal

Full Information

First Posted
August 26, 2016
Last Updated
December 19, 2018
Sponsor
Daiichi Sankyo Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02885662
Brief Title
Study of CS-3150 in Patients With Primary Aldosteronism
Official Title
A Study of CS-3150 to Evaluate Efficacy and Safety in Patients With Primary Aldosteronism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism
Keywords
Primary aldosteronism, Hypertension, mineralocorticoid receptor antagonist, Developmental Phase III

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CS-3150
Arm Type
Experimental
Arm Description
CS-3150 2.5 to 5.0 mg , orally, once daily after breakfast for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
CS-3150
Intervention Description
CS-3150 2.5 to 5.0 mg , orally.
Primary Outcome Measure Information:
Title
Change from baseline in sitting blood pressure
Description
Change from baseline in sitting systolic and diastolic blood pressure
Time Frame
Baseline to end of Week 12
Secondary Outcome Measure Information:
Title
Time course of sitting blood pressure
Description
Time course of sitting systolic and diastolic blood pressure
Time Frame
Baseline to end of Week 12
Title
Proportion of patients achieving sitting blood pressure goal
Time Frame
Baseline to end of Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

Study of CS-3150 in Patients With Primary Aldosteronism

We'll reach out to this number within 24 hrs