Trial · NCT03254108
Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
NCT03254108, Not applicable, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2021-07-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure. Trials, record NCT03254108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03254108
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
- NCT number
- NCT03254108
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 61 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Congestive Heart Failure
- Interventions
- OPC-61815 injection 2mg, OPC-61815 injection 4mg, OPC-61815 injection 8mg, OPC-61815 injection 16mg, Tolvaptan tablet 15mg
- First posted
- 2017-08-18
- Last updated
- 2021-07-28
- Results first posted
- 2021-07-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1 | Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug | |
| Primary | Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1 | Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1 | Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug | Subjects treated with the IMP at least once and had at least 1 data of primary endpoint after IMP administration | ng/mL | MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1 | Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug | Subjects treated with the IMP at least once and had at least 1 data of primary endpoint after IMP administration | ng*h/mL | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1 | OPC-61815 Injection 2mg | 41.4 | Standard Deviation 11.4 | ng/mL | |
| Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1 | OPC-61815 Injection 4mg | 98.6 | Standard Deviation 43.7 | ng/mL | |
| Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1 | OPC-61815 Injection 8mg | 149 | Standard Deviation 61.7 | ng/mL | |
| Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1 | OPC-61815 Injection 16mg | 282 | Standard Deviation 96.0 | ng/mL | |
| Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1 | Tolvaptan Tablet 15mg | 325 | Standard Deviation 194 | ng/mL | |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1 | OPC-61815 Injection 2mg | 356 | Standard Deviation 157 | ng*h/mL | |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1 | OPC-61815 Injection 4mg | 983 | Standard Deviation 563 | ng*h/mL | |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1 | OPC-61815 Injection 8mg | 1340 | Standard Deviation 522 | ng*h/mL | |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1 | OPC-61815 Injection 16mg | 2400 | Standard Deviation 1030 | ng*h/mL | |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1 | Tolvaptan Tablet 15mg | 2850 | Standard Deviation 1580 | ng*h/mL |
Source ClinicalTrials.gov
Participant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OPC-61815 Injection 2mg | 13 | |
| Overall Study | STARTED | OPC-61815 Injection 4mg | 12 | |
| Overall Study | STARTED | OPC-61815 Injection 8mg | 12 | |
| Overall Study | STARTED | OPC-61815 Injection 16mg | 12 | |
| Overall Study | STARTED | Tolvaptan Tablet 15mg | 12 | |
| Overall Study | Received Treatment | OPC-61815 Injection 2mg | 13 | |
| Overall Study | Received Treatment | OPC-61815 Injection 4mg | 12 | |
| Overall Study | Received Treatment | OPC-61815 Injection 8mg | 12 | |
| Overall Study | Received Treatment | OPC-61815 Injection 16mg | 11 | |
| Overall Study | Received Treatment | Tolvaptan Tablet 15mg | 12 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events270
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cardiac failure congestive | Cardiac disorders | OPC-61815 Injection 2mg | 1 | 13 | |
| other | Cardiac failure congestive | Cardiac disorders | OPC-61815 Injection 4mg | 0 | 12 | |
| other | Cardiac failure congestive | Cardiac disorders | OPC-61815 Injection 8mg | 0 | 12 | |
| other | Cardiac failure congestive | Cardiac disorders | OPC-61815 Injection 16mg | 0 | 11 | |
| other | Cardiac failure congestive | Cardiac disorders | Tolvaptan Tablet 15mg | 0 | 12 | |
| other | Ventricular tachycardia | Cardiac disorders | OPC-61815 Injection 2mg | 0 | 13 | |
| other | Ventricular tachycardia | Cardiac disorders | OPC-61815 Injection 4mg | 0 | 12 | |
| other | Ventricular tachycardia | Cardiac disorders | OPC-61815 Injection 8mg | 1 | 12 | |
| other | Ventricular tachycardia | Cardiac disorders | OPC-61815 Injection 16mg | 0 | 11 | |
| other | Ventricular tachycardia | Cardiac disorders | Tolvaptan Tablet 15mg | 0 | 12 |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OPC-61815 Injection 2mg | 0 | 13 |
| Total, all-cause mortality | OPC-61815 Injection 4mg | 0 | 12 |
| Total, all-cause mortality | OPC-61815 Injection 8mg | 0 | 12 |
| Total, all-cause mortality | OPC-61815 Injection 16mg | 0 | 11 |
| Total, all-cause mortality | Tolvaptan Tablet 15mg | 0 | 12 |
| Total, other adverse events | OPC-61815 Injection 2mg | 7 | 13 |
| Total, other adverse events | OPC-61815 Injection 4mg | 7 | 12 |
| Total, other adverse events | OPC-61815 Injection 8mg | 4 | 12 |
| Total, other adverse events | OPC-61815 Injection 16mg | 8 | 11 |
| Total, other adverse events | Tolvaptan Tablet 15mg | 10 | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03254108
GET https://conductscience.org/api/trials/v1/NCT03254108/events?page=2