Congestive Heart FailureNCT03254108

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

A study testing OPC-61815 injection 2mg, OPC-61815 injection 4mg and OPC-61815 injection 8mg in people with Congestive Heart Failure, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 85 years
Conditions the study is for: Congestive Heart Failure
What is being tested?: OPC-61815 injection 2mg, OPC-61815 injection 4mg and OPC-61815 injection 8mg
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteJapan
Study dates: 6 Nov 2017to 24 Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kanto

Other trials in Japan

About this study

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

Conditions: Congestive Heart Failure
Being tested: OPC-61815 injection 2mg, OPC-61815 injection 4mg, OPC-61815 injection 8mg, OPC-61815 injection 16mg, Tolvaptan tablet 15mg
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03254108
Study group	Role	What they receive
OPC-61815 injection 2mg	Experimental	Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg. Receives: Drug: OPC-61815 injection 2mg
OPC-61815 injection 4mg	Experimental	Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg. Receives: Drug: OPC-61815 injection 4mg
OPC-61815 injection 8mg	Experimental	Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg. Receives: Drug: OPC-61815 injection 8mg
OPC-61815 injection 16mg	Experimental	Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg. Receives: Drug: OPC-61815 injection 16mg
Tolvaptan tablet 15mg	Active comparator	Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo. Receives: Drug: Tolvaptan tablet 15mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1
Measured: 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
Measured: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Nov 201724 Apr 2018

First posted18 Aug 2017
Study start6 Nov 2017
Primary completion14 Apr 2018
Study completion24 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03254108
Sponsor's protocol ID: 263-102-00001
Other IDs: JapicCTI-173676
Status last verified: Jul 2021
First submitted: 16 Aug 2017
Last updated: 28 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Congestive Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03254108
Acronym / sponsor ID: 263-102-00001
Conditions: Congestive Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 6 Nov 2017 (actual)
Primary completion: 14 Apr 2018 (actual)
Study completion: 24 Apr 2018 (actual)
First posted: 18 Aug 2017 (actual)
Results: Posted 28 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

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

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPC-61815 injection 2mgOnce 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
OPC-61815 injection 4mgOnce 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
OPC-61815 injection 8mgOnce 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
OPC-61815 injection 16mgOnce 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
Tolvaptan tablet 15mgOnce 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

Primary outcome

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
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

Results and safety

Results posted to the registry on 28 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPC-61815 Injection 2mg	13	13
OPC-61815 Injection 4mg	12	10
OPC-61815 Injection 8mg	12	12
OPC-61815 Injection 16mg	12	11
Tolvaptan Tablet 15mg	12	9

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	OPC-61815 Injection 2mg n = 11	OPC-61815 Injection 4mg n = 12	OPC-61815 Injection 8mg n = 12	OPC-61815 Injection 16mg n = 11	Tolvaptan Tablet 15mg n = 12
Value	41.4 (11.4)	98.6 (43.7)	149 (61.7)	282 (96.0)	325 (194)

Population analysed: Subjects treated with the IMP at least once and had at least 1 data of primary endpoint after IMP administration

Primary outcome: 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. Mean (Standard Deviation). Unit: ng*h/mL

Measure	OPC-61815 Injection 2mg n = 11	OPC-61815 Injection 4mg n = 12	OPC-61815 Injection 8mg n = 12	OPC-61815 Injection 16mg n = 11	Tolvaptan Tablet 15mg n = 12
Value	356 (157)	983 (563)	1340 (522)	2400 (1030)	2850 (1580)

Population analysed: Subjects treated with the IMP at least once and had at least 1 data of primary endpoint after IMP administration

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-61815 Injection 2mg	0 of 13 (0%)	7 of 13 (53.8%)	0 of 13
OPC-61815 Injection 4mg	1 of 12 (8.3%)	7 of 12 (58.3%)	0 of 12
OPC-61815 Injection 8mg	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
OPC-61815 Injection 16mg	0 of 11 (0%)	8 of 11 (72.7%)	0 of 11
Tolvaptan Tablet 15mg	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Congestive Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hiroaki Ono study director

Otsuka Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing OPC-61815 injection 2mg, OPC-61815 injection 4mg and OPC-61815 injection 8mg in people with Congestive Heart Failure, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03254108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.