Back to resultsA Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
CS-3150
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, moderate renal impairment, mineralocorticoid receptor antagonist, CS-3150, Japanese
Eligibility Criteria
Inclusion Criteria:
- Men and women Aged 20 years or older and 80 years or younger at informed consent
- Subjects with hypertension (Sitting systolic blood pressure SBP >= 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP >= 80 mmHg and < 110 mmHg)
- estimated glomerular filtration rate 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
- Serum potassium level < 3.5 or >= 5.1 mEq/L
- Subjects under Insulin treatment
- Subjects under or pre-planned for hemodialysis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CS-3150
Arm Description
CS-3150 1.25 to 5.0 mg , orally, once daily after breakfast for 12 weeks
Outcomes
Primary Outcome Measures
Change from baseline in sitting systolic and diastolic blood pressure
Secondary Outcome Measures
Change from baseline in UACR
Urine Albumin Creatinine Ratio (UACR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02448628
Brief Title
A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment
Official Title
A Multi-center, Open Label, Dose Titration, Exploratory Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, moderate renal impairment, mineralocorticoid receptor antagonist, CS-3150, Japanese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CS-3150
Arm Type
Experimental
Arm Description
CS-3150 1.25 to 5.0 mg , orally, once daily after breakfast for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CS-3150
Primary Outcome Measure Information:
Title
Change from baseline in sitting systolic and diastolic blood pressure
Time Frame
Baseline to end of Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in UACR
Description
Urine Albumin Creatinine Ratio (UACR)
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:
Men and women Aged 20 years or older and 80 years or younger at informed consent
Subjects with hypertension (Sitting systolic blood pressure SBP >= 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP >= 80 mmHg and < 110 mmHg)
estimated glomerular filtration rate 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
Serum potassium level < 3.5 or >= 5.1 mEq/L
Subjects under Insulin treatment
Subjects under or pre-planned for hemodialysis
Facility Information:
City
Osaka
ZIP/Postal Code
530-0001
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
A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment
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