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

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
OPC-61815 injection 2mg
OPC-61815 injection 4mg
OPC-61815 injection 8mg
OPC-61815 injection 16mg
Tolvaptan tablet 15mg
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

OPC-61815 injection 2mg

OPC-61815 injection 4mg

OPC-61815 injection 8mg

OPC-61815 injection 16mg

Tolvaptan tablet 15mg

Arm Description

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.

Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1
Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1

Secondary Outcome Measures

Full Information

First Posted
August 16, 2017
Last Updated
July 8, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03254108
Brief Title
Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
April 14, 2018 (Actual)
Study Completion Date
April 24, 2018 (Actual)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPC-61815 injection 2mg
Arm Type
Experimental
Arm Description
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
Arm Title
OPC-61815 injection 4mg
Arm Type
Experimental
Arm Description
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
Arm Title
OPC-61815 injection 8mg
Arm Type
Experimental
Arm Description
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
Arm Title
OPC-61815 injection 16mg
Arm Type
Experimental
Arm Description
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
Arm Title
Tolvaptan tablet 15mg
Arm Type
Active Comparator
Arm Description
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
Intervention Type
Drug
Intervention Name(s)
OPC-61815 injection 2mg
Intervention Description
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
Intervention Type
Drug
Intervention Name(s)
OPC-61815 injection 4mg
Intervention Description
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
Intervention Type
Drug
Intervention Name(s)
OPC-61815 injection 8mg
Intervention Description
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
Intervention Type
Drug
Intervention Name(s)
OPC-61815 injection 16mg
Intervention Description
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
Intervention Type
Drug
Intervention Name(s)
Tolvaptan tablet 15mg
Intervention Description
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
Primary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present Subjects who are currently hospitalized or who are able to be hospitalized during the trial Exclusion Criteria: Subjects with acute heart failure Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan Subjects who are unable to sense thirst or who have difficulty with fluid intake
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Ono
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Kanto
Country
Japan

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

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

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