Back to resultsA Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
Primary Purpose
Cardiac Edema (CHF)
Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
OPC 131461 10mg group
OPC 131461 5mg group
OPC 131461 2mg group
OPC 131461 1mg group
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Edema (CHF)
Eligibility Criteria
Inclusion Criteria: Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload. Subjects undergoing any of the following diuretic therapies Loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule Concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses Concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses Subjects who were currently hospitalized or who are able to be hospitalized Exclusion Criteria: Subjects with acute heart failure Subjects with an assisted circulation device Subjects who cannot sense thirst or who have difficulty in ingesting water
Sites / Locations
- Harasanshin HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
OPC 131461 10mg group
OPC 131461 5mg group
OPC 131461 2mg group
OPC 131461 1mg group
Placebo
Arm Description
OPC-131461 5 mg tablet ｘ 2
OPC-131461 5 mg tablet and placebo tablet
OPC-131461 1 mg tablet ｘ 2
OPC-131461 1 mg tablet and placebo tablet
Placebo tablet
Outcomes
Primary Outcome Measures
Change in body weight from baseline to last assessment time point (the day after investigational medicinal product [IMP] administration) by Day 8
The primary endpoint is the change in body weight from baseline (before IMP administration on Day 1) to last assessment time point (the day after IMP administration) by Day 8.
Secondary Outcome Measures
Full Information
NCT ID
NCT05615363
First Posted
November 7, 2022
Last Updated
March 3, 2023
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05615363
Brief Title
A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Doseranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical 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 investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF with volume overload despite having received diuretics other than vasopressin antagonists
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Edema (CHF)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OPC 131461 10mg group
Arm Type
Experimental
Arm Description
OPC-131461 5 mg tablet ｘ 2
Arm Title
OPC 131461 5mg group
Arm Type
Experimental
Arm Description
OPC-131461 5 mg tablet and placebo tablet
Arm Title
OPC 131461 2mg group
Arm Type
Experimental
Arm Description
OPC-131461 1 mg tablet ｘ 2
Arm Title
OPC 131461 1mg group
Arm Type
Experimental
Arm Description
OPC-131461 1 mg tablet and placebo tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet
Intervention Type
Drug
Intervention Name(s)
OPC 131461 10mg group
Intervention Description
OPC-131461 5 mg tablet x 2，once-daily oral administration for 14 days
Intervention Type
Drug
Intervention Name(s)
OPC 131461 5mg group
Intervention Description
OPC-131461 5 mg tablet and placebo tablet，once-daily oral administration for 14 days
Intervention Type
Drug
Intervention Name(s)
OPC 131461 2mg group
Intervention Description
OPC-131461 1 mg tablet x 2，once-daily oral administration for 14 days
Intervention Type
Drug
Intervention Name(s)
OPC 131461 1mg group
Intervention Description
OPC-131461 1 mg tablet and placebo tablet，once-daily oral administration for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet，once-daily oral administration for 14 days
Primary Outcome Measure Information:
Title
Change in body weight from baseline to last assessment time point (the day after investigational medicinal product [IMP] administration) by Day 8
Description
The primary endpoint is the change in body weight from baseline (before IMP administration on Day 1) to last assessment time point (the day after IMP administration) by Day 8.
Time Frame
From baseline (before IMP administration on Day 1) to last assessment time point (the day after IMP administration) by Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload.
Subjects undergoing any of the following diuretic therapies
Loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule
Concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses
Concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses
Subjects who were currently hospitalized or who are able to be hospitalized
Exclusion Criteria:
Subjects with acute heart failure
Subjects with an assisted circulation device
Subjects who cannot sense thirst or who have difficulty in ingesting water
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Drug Information Center
Phone
+81-3-6361-7314
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehisa Matsumaru
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Harasanshin Hospital
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
Learn more about this trial
A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
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