Trial · NCT00544869

A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)

NCT00544869, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2014-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure). Trials, record NCT00544869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00544869

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)
NCT number: NCT00544869
Status: Completed
Phases: Phase 3
Enrollment: 52 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Cardiac Edema
Interventions: OPC-41061 （Tolvaptan)
First posted: 2007-10-16
Last updated: 2014-01-30
Results first posted: 2014-01-30

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Body Weight	Baseline, Day 14 or at the time of final drug administration	The change of body weight from baseline at final observation

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Body Weight	Baseline, Day 14 or at the time of final drug administration		Kg	MEAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Body Weight	Stopped at End of Treatment Period 1	-2.05	Standard Deviation 1.86	Kg
Body Weight	Continued at 15 mg/Day	-1.31	Standard Deviation 2.95	Kg
Body Weight	Dose Escalated to 30 mg/Day	-2.9	Standard Deviation 2.69	Kg

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Stopped at End of Treatment Period 1	36
Overall Study	STARTED	Continued at 15 mg/Day	14
Overall Study	STARTED	Dose Escalated to 30 mg/Day	2
Overall Study	COMPLETED	Stopped at End of Treatment Period 1	24
Overall Study	COMPLETED	Continued at 15 mg/Day	12
Overall Study	COMPLETED	Dose Escalated to 30 mg/Day	2
Overall Study	NOT COMPLETED	Stopped at End of Treatment Period 1	12
Overall Study	NOT COMPLETED	Continued at 15 mg/Day	2
Overall Study	NOT COMPLETED	Dose Escalated to 30 mg/Day	0

Source ClinicalTrials.gov

Adverse events120

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	Anaemia	Blood and lymphatic system disorders	Stopped at End of Treatment Period 1	0	36	0
other	Anaemia	Blood and lymphatic system disorders	Continued at 15 mg/Day	1	13	1
other	Anaemia	Blood and lymphatic system disorders	Dose Escalated to 30 mg/Day	0	2	0
other	Cardiac Failure	Cardiac disorders	Stopped at End of Treatment Period 1	0	36	0
other	Cardiac Failure	Cardiac disorders	Continued at 15 mg/Day	1	13	1
other	Cardiac Failure	Cardiac disorders	Dose Escalated to 30 mg/Day	0	2	0
other	Ventricular Extrasystoles	Cardiac disorders	Stopped at End of Treatment Period 1	0	36	0
other	Ventricular Extrasystoles	Cardiac disorders	Continued at 15 mg/Day	2	13	2
other	Ventricular Extrasystoles	Cardiac disorders	Dose Escalated to 30 mg/Day	0	2	0
other	Ventricular Tachycardia	Cardiac disorders	Stopped at End of Treatment Period 1	4	36	4

1 to 10 of 120Source ClinicalTrials.gov

See all 120 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Stopped at End of Treatment Period 1
Total, all-cause mortality	Continued at 15 mg/Day
Total, all-cause mortality	Dose Escalated to 30 mg/Day
Total, other adverse events	Stopped at End of Treatment Period 1	30	36
Total, other adverse events	Continued at 15 mg/Day	12	13
Total, other adverse events	Dose Escalated to 30 mg/Day	2	2
Total, serious adverse events	Stopped at End of Treatment Period 1	3	36
Total, serious adverse events	Continued at 15 mg/Day	1	13
Total, serious adverse events	Dose Escalated to 30 mg/Day	0	2

Source ClinicalTrials.gov

Papers0

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00544869

GET https://conductscience.org/api/trials/v1/NCT00544869/events?page=2

API reference For AI assistants