Trial · NCT00462670

A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

NCT00462670, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2014-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure). Trials, record NCT00462670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00462670

On this page

Trial

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

Title: A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
NCT number: NCT00462670
Status: Completed
Phases: Phase 3
Enrollment: 110 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Edema, Cardiac
Interventions: OPC-41061(Tolvaptan)
First posted: 2007-04-19
Last updated: 2014-02-04
Results first posted: 2014-02-04

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Body Weight (Amount of Change)	baseline, Day 7 or at the time of final trial drug administration	Change in body weight from baseline at the time of final trial drug administration
Secondary	Body Weight (Percent Change)	baseline, Day 7 or at the time of final trial drug administration	Percent change in body weight from baseline at the time of final trial drug administration

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	Body Weight (Amount of Change)	baseline, Day 7 or at the time of final trial drug administration		Kg	MEAN
SECONDARY	Body Weight (Percent Change)	baseline, Day 7 or at the time of final trial drug administration		percentage of body weight (Kg)	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Body Weight (Amount of Change)	Placebo	-0.45	Standard Deviation 0.93	Kg
Body Weight (Amount of Change)	OPC-41061 15mg	-1.54	Standard Deviation 1.61	Kg
Body Weight (Percent Change)	Placebo	-0.77	Standard Deviation 1.65	percentage of body weight (Kg)
Body Weight (Percent Change)	OPC-41061 15mg	-2.50	Standard Deviation 2.55	percentage of body weight (Kg)

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	57
Overall Study	STARTED	OPC-41061 15mg	53
Overall Study	COMPLETED	Placebo	52
Overall Study	COMPLETED	OPC-41061 15mg	46
Overall Study	NOT COMPLETED	Placebo	5
Overall Study	NOT COMPLETED	OPC-41061 15mg	7

Source ClinicalTrials.gov

Adverse events56

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	Ventricular Extrasystoles	Cardiac disorders	Placebo	2	57	2
other	Ventricular Extrasystoles	Cardiac disorders	OPC-41061 15mg	0	53	0
other	Constipation	Gastrointestinal disorders	Placebo	3	57	3
other	Constipation	Gastrointestinal disorders	OPC-41061 15mg	9	53	10
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	57	2
other	Diarrhoea	Gastrointestinal disorders	OPC-41061 15mg	2	53	2
other	Nausea	Gastrointestinal disorders	Placebo	0	57	0
other	Nausea	Gastrointestinal disorders	OPC-41061 15mg	3	53	3
other	Face Oedema	General disorders	Placebo	2	57	2
other	Face Oedema	General disorders	OPC-41061 15mg	0	53	0

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	OPC-41061 15mg
Total, other adverse events	Placebo	31	57
Total, other adverse events	OPC-41061 15mg	28	53
Total, serious adverse events	Placebo	7	57
Total, serious adverse events	OPC-41061 15mg	2	53

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
OPC-41061 15mg vs Placebo: serious adverse events

Source Trial comparisons

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/NCT00462670

GET https://conductscience.org/api/trials/v1/NCT00462670/events?page=2

API reference For AI assistants