Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

July 8, 2021 updated by: Otsuka Pharmaceutical Co., Ltd.

A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group Comparison Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects who are currently on treatment with any of the following diuretics

    • Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
    • Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
    • Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
  2. Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
  3. Subjects who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion Criteria:

  1. Subjects with acute heart failure
  2. Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
  3. Subjects who are unable to sense thirst or who have difficulty with fluid intake

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
Experimental: OPC-61815 injection 2mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
Drug: OPC-61815 injection 2mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
Experimental: OPC-61815 injection 4mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
Drug: OPC-61815 injection 4mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
Experimental: OPC-61815 injection 8mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
Drug: OPC-61815 injection 8mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
Experimental: OPC-61815 injection 16mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
Drug: OPC-61815 injection 16mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
Active Comparator: Tolvaptan tablet 15mg
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
Drug: Tolvaptan tablet 15mg
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1
Time Frame: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1
Time Frame: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Hiroaki Ono, 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)

November 6, 2017

Primary Completion (Actual)

April 14, 2018

Study Completion (Actual)

April 24, 2018

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 263-102-00001
  • JapicCTI-173676 (Other Identifier: Japic)

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
  • Statistical Analysis Plan (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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