Trial · NCT00479336

A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema

NCT00479336, Phase 2, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2014-03-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema. Trials, record NCT00479336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00479336

On this page

Trial

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

Title: A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema
NCT number: NCT00479336
Status: Completed
Phases: Phase 2
Enrollment: 104 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Cirrhosis
Interventions: OPC-41061 7.5mg, OPC-41061 placebo, OPC-41061 15mg, OPC-41601 30mg
First posted: 2007-05-28
Last updated: 2014-03-14
Results first posted: 2014-03-14

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 discontied of treatment	Changes in body wight from baseline at the final timepoint (LOCF). A linear regression model using changes in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset.
Secondary	Abdominal Circumference	Baseline, Day 7 or at the discontied of treatment	Change in abdominal circumference from baseline (LOCF)

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 discontied of treatment	Full Analysis Set; LOCF	Kg	MEAN
SECONDARY	Abdominal Circumference	Baseline, Day 7 or at the discontied of treatment	Full Analysis Set; LOCF	cm	MEAN

Source ClinicalTrials.gov

Results by group8

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	-0.68	Standard Deviation 2.50	Kg
Body Weight (Amount of Change)	OPC-41061 7.5 mg	-2.31	Standard Deviation 2.35	Kg
Body Weight (Amount of Change)	OPC-41061 15 mg	-1.88	Standard Deviation 2.45	Kg
Body Weight (Amount of Change)	OPC-41061 30 mg	-1.67	Standard Deviation 1.46	Kg
Abdominal Circumference	Placebo	-1.39	Standard Deviation 3.16	cm
Abdominal Circumference	OPC-41061 7.5 mg	-2.98	Standard Deviation 3.22	cm
Abdominal Circumference	OPC-41061 15 mg	-2.42	Standard Deviation 3.96	cm
Abdominal Circumference	OPC-41061 30 mg	-2.62	Standard Deviation 2.83	cm

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	27
Overall Study	STARTED	OPC-41061 7.5 mg	26
Overall Study	STARTED	OPC-41061 15 mg	25
Overall Study	STARTED	OPC-41061 30 mg	26
Overall Study	COMPLETED	Placebo	23
Overall Study	COMPLETED	OPC-41061 7.5 mg	20
Overall Study	COMPLETED	OPC-41061 15 mg	24
Overall Study	COMPLETED	OPC-41061 30 mg	21
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	OPC-41061 7.5 mg	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events172

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	Placebo	1	26	1
other	Anaemia	Blood and lymphatic system disorders	OPC-41061 7.5 mg	0	25	0
other	Anaemia	Blood and lymphatic system disorders	OPC-41061 15 mg	0	25	0
other	Anaemia	Blood and lymphatic system disorders	OPC-41061 30 mg	2	25	2
other	Supraventricular Extrasystoles	Cardiac disorders	Placebo	0	26	0
other	Supraventricular Extrasystoles	Cardiac disorders	OPC-41061 7.5 mg	2	25	2
other	Supraventricular Extrasystoles	Cardiac disorders	OPC-41061 15 mg	0	25	0
other	Supraventricular Extrasystoles	Cardiac disorders	OPC-41061 30 mg	1	25	1
other	Constipation	Gastrointestinal disorders	Placebo	2	26	2
other	Constipation	Gastrointestinal disorders	OPC-41061 7.5 mg	1	25	1

1 to 10 of 172Source ClinicalTrials.gov

See all 172 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	OPC-41061 7.5 mg
Total, all-cause mortality	OPC-41061 15 mg
Total, all-cause mortality	OPC-41061 30 mg
Total, other adverse events	Placebo	18	26
Total, other adverse events	OPC-41061 7.5 mg	20	25
Total, other adverse events	OPC-41061 15 mg	19	25
Total, other adverse events	OPC-41061 30 mg	24	25
Total, serious adverse events	Placebo	5	26
Total, serious adverse events	OPC-41061 7.5 mg	0	25

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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/NCT00479336

GET https://conductscience.org/api/trials/v1/NCT00479336/events?page=2

API reference For AI assistants