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Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

Primary Purpose

Hypertension With Moderate Renal Impairment

Status
Completed
Phase
Phase 3
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 Hypertension With Moderate Renal Impairment focused on measuring Mineralocorticoid receptor antagonist, Moderate renal impairment, Hypertension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects aged 20 or order to 80 or younger years at informed consent
  • Subjects with hypertension (Sitting SBP ≥ 140 mmHg, <180 mmHg and Sitting DBP ≥ 80 mmHg, <110 mmHg
  • Treatment with an ARB or ACE inhibitor
  • eGFR ≥ 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2

Exclusion Criteria:

  • Secondary hypertension or malignant hypertension
  • Diabetes mellitus with albuminuria
  • Subjects under Insulin treatment
  • Subjects under or pre-planned for hemodialysis
  • Serum potassium level < 3.5 or ≥ 4.8 mEq/L

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CS-3150

Arm Description

CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time course of systolic and diastolic blood pressure
Time course of systolic and diastolic blood pressure
Proportion of patients achieving blood pressure control
Proportion of patients achieving blood pressure control

Full Information

First Posted
June 17, 2016
Last Updated
December 19, 2018
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02807987
Brief Title
Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment
Official Title
A Study of CS-3150 to Evaluate Efficacy and Safety in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
May 15, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension With Moderate Renal Impairment
Keywords
Mineralocorticoid receptor antagonist, Moderate renal impairment, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CS-3150
Arm Type
Experimental
Arm Description
CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CS-3150
Intervention Description
CS-3150 1.25 to 2.5, 5mg, orally
Primary Outcome Measure Information:
Title
Change from baseline in sitting systolic and diastolic 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 systolic and diastolic blood pressure
Description
Time course of systolic and diastolic blood pressure
Time Frame
Baseline to end of Week 12
Title
Proportion of patients achieving blood pressure control
Description
Proportion of patients achieving blood pressure control
Time Frame
Baseline to end of Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects aged 20 or order to 80 or younger years at informed consent Subjects with hypertension (Sitting SBP ≥ 140 mmHg, <180 mmHg and Sitting DBP ≥ 80 mmHg, <110 mmHg Treatment with an ARB or ACE inhibitor eGFR ≥ 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2 Exclusion Criteria: Secondary hypertension or malignant hypertension Diabetes mellitus with albuminuria Subjects under Insulin treatment Subjects under or pre-planned for hemodialysis Serum potassium level < 3.5 or ≥ 4.8 mEq/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Nagano
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 Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

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