- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05615363
A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
January 29, 2024 updated by: Otsuka Pharmaceutical Co., Ltd.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Doseranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
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
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
155
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Drug Information Center
- Phone Number: +81-3-6361-7314
Study Locations
-
-
-
Fukuoka, Japan
- Recruiting
- Harasanshin hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo tablet
|
Placebo tablet,once-daily oral administration for 14 days
|
Experimental: OPC 131461 10mg group
OPC-131461 5 mg tablet x 2
|
OPC-131461 5 mg tablet x 2,once-daily oral administration for 14 days
|
Experimental: OPC 131461 5mg group
OPC-131461 5 mg tablet and placebo tablet
|
OPC-131461 5 mg tablet and placebo tablet,once-daily oral administration for 14 days
|
Experimental: OPC 131461 2mg group
OPC-131461 1 mg tablet x 2
|
OPC-131461 1 mg tablet x 2,once-daily oral administration for 14 days
|
Experimental: OPC 131461 1mg group
OPC-131461 1 mg tablet and placebo tablet
|
OPC-131461 1 mg tablet and placebo tablet,once-daily oral administration for 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body weight from baseline to last assessment time point (the day after investigational medicinal product [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
|
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.
|
From baseline (before IMP administration on Day 1) to last assessment time point (the day after IMP administration) by Day 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Takehisa Matsumaru, Otsuka Pharmaceutical Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2023
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
November 7, 2022
First Submitted That Met QC Criteria
November 7, 2022
First Posted (Actual)
November 14, 2022
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 351-102-00004
- jRCT (Registry Identifier: jRCT2071220069)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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