Trial · NCT01439009

Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients

NCT01439009, Phase 4, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2019-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients. Trials, record NCT01439009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01439009

On this page

Trial

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

Title: Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients
NCT number: NCT01439009
Status: Completed
Phases: Phase 4
Enrollment: 100 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Heart Failure
Interventions: Tolvaptan, Placebo of tolvaptan
First posted: 2011-09-22
Last updated: 2019-10-22
Results first posted: 2019-10-22

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Cummulative Incidence of Events at Week 26	Week 26	From start day of IMP administration to final day of follow up period, 1) and 2) below were defined as event 1. Death from cardiovascular events 2. Worsening of heart failure * The day of re-hospitalization due to worsening of heart failure * The day of medication below due to worsening of heart failure Phosphodiesterase III inhibitors (Injection), Catecholamine preparations (Injection), Colforsin preparations (Injection), Diuretics (Injection), Human atrial natriuretic peptide preparations (Injection)：Calperitide (Injection)
Primary	Mortality （Number of Death）	Week26	Statistical comparison was not done.
Primary	Body Weight	Day15	The comparison of the average of amount of change from baseline. Statistical comparison was not done.
Primary	Number of Subjects Whose Lower Limb Edema Severity Grading Improved by One or More Grade	Day15	Of the subjects who had lower limb edema at baseline, the number of subjects whose lower limb edema severity grading. Statistical comparison was not done.
Primary	Jugular Venous Distension	Day15	The comparison of the average of amount of change from baseline. Statistical comparison was not done.
Primary	Change in Liver Size From Baseline	Day15	The comparison of the average of amount of change from baseline. Statistical comparison was not done．
Primary	Pulmonary Rales	Day15	Of the subjects who had pulmonary rales at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done.
Primary	Third Heart Sound	Day15	Of the subjects who had third heart sound at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done.
Primary	Cardiothoracic Ratio	Day15	Investigator majored Thoracic length and Cardiac length from chest X-ray. Cardiothoracic Ratio was calculated from Cardiac length/Thoracic length\*100. Lowering of Cardiothoracic Ratio suggests recovery from heart congestion. The comparison of the average of amount of change from baseline. Statistical comparison was not done.
Primary	Pulmonary Congestion	Day15	Of the subjects who had pulmonary congestion at baseline, the number of subjects whose pulmonary congestion severity grading showed an improvement of one grade or more (eg, moderate to mild) at completion of treatment. Statistical comparison was not done.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Cummulative Incidence of Events at Week 26	Week 26	Percentage of events at 26 weeks	NUMBER
PRIMARY	Mortality （Number of Death）	Week26	participants	NUMBER
PRIMARY	Body Weight	Day15	kg	MEAN
PRIMARY	Number of Subjects Whose Lower Limb Edema Severity Grading Improved by One or More Grade	Day15	participants	NUMBER
PRIMARY	Jugular Venous Distension	Day15	cm	MEAN
PRIMARY	Change in Liver Size From Baseline	Day15	cm	MEAN
PRIMARY	Pulmonary Rales	Day15	participants	NUMBER
PRIMARY	Third Heart Sound	Day15	participants	NUMBER
PRIMARY	Cardiothoracic Ratio	Day15	Percentage	MEAN
PRIMARY	Pulmonary Congestion	Day15	participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group26

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

Outcome	Group	Value	Spread	Units
Cummulative Incidence of Events at Week 26	Tolvaptan	35.6		Percentage of events at 26 weeks
Cummulative Incidence of Events at Week 26	Placebo	43.8		Percentage of events at 26 weeks
Mortality （Number of Death）	Tolvaptan	2		participants
Mortality （Number of Death）	Placebo	3		participants
Body Weight	Tolvaptan	-1.99	Standard Deviation 1.61	kg
Body Weight	Placebo	-1.20	Standard Deviation 1.97	kg
Number of Subjects Whose Lower Limb Edema Severity Grading Improved by One or More Grade	Tolvaptan	27		participants
Number of Subjects Whose Lower Limb Edema Severity Grading Improved by One or More Grade	Placebo	16		participants
Jugular Venous Distension	Tolvaptan	-0.94	Standard Deviation 2.07	cm
Jugular Venous Distension	Placebo	-1.23	Standard Deviation 2.78	cm

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Tolvaptan	50
Overall Study	STARTED	Placebo	50
Overall Study	COMPLETED	Tolvaptan	42
Overall Study	COMPLETED	Placebo	47
Overall Study	NOT COMPLETED	Tolvaptan	8
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events52

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
other	Constipation	Gastrointestinal disorders	Tolvaptan	6	50
other	Constipation	Gastrointestinal disorders	Placebo	2	50
other	Thirst	General disorders	Tolvaptan	10	50
other	Thirst	General disorders	Placebo	1	50
other	Contusion	Injury, poisoning and procedural complications	Tolvaptan	1	50
other	Contusion	Injury, poisoning and procedural complications	Placebo	3	50
other	Blood potassium increased	Investigations	Tolvaptan	3	50
other	Blood potassium increased	Investigations	Placebo	1	50
other	Blood sodium increased	Investigations	Tolvaptan	8	50
other	Blood sodium increased	Investigations	Placebo	0	50

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tolvaptan
Total, all-cause mortality	Placebo
Total, other adverse events	Tolvaptan	31	50
Total, other adverse events	Placebo	7	50
Total, serious adverse events	Tolvaptan	24	50
Total, serious adverse events	Placebo	22	50

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 comparisons8

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

Comparison	Source
Tolvaptan vs Placebo: Number of Subjects Whose New York Heart Association (NYHA) Classification Improved by One More Grade From Baseline	Trial comparisons
Tolvaptan vs Placebo: Mortality （Number of Death）	Trial comparisons
Tolvaptan vs Placebo: Dypnea	Trial comparisons
Tolvaptan vs Placebo: Pulmonary Congestion	Trial comparisons
Tolvaptan vs Placebo: Pulmonary Rales	Trial comparisons
Tolvaptan vs Placebo: Number of Subjects Whose Lower Limb Edema Severity Grading Improved by One or More Grade	Trial comparisons
Tolvaptan vs Placebo: Third Heart Sound	Trial comparisons
Tolvaptan vs Placebo: serious adverse events	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.

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