Trial · NCT00592475

A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients

NCT00592475, Phase 2, Completed, Cumberland Pharmaceuticals; results first posted 2010-09-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients. Trials, record NCT00592475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00592475

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Trial

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

Title: A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients
NCT number: NCT00592475
Status: Completed
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Cumberland Pharmaceuticals
Conditions: Liver Cirrhosis
Interventions: conivaptan, Placebo
First posted: 2008-01-14
Last updated: 2014-05-15
Other registries' IDs: eudract:2007-001661-15
Results first posted: 2010-09-28
Limitations and caveats: Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Baseline and 0.5, 1, and 1.5 hours post dose	Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Primary	Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose	Baseline and 0.5, 1, and 1.5 hours post dose	Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Primary	Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose	Baseline and 0.5, 1, and 1.5 hours post dose	Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Primary	Change From Baseline in Blood Pressure at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose	Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose	Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Primary	Change From Baseline in Heart Rate at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose	Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose	Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Secondary	Change From Baseline in Serum Sodium Levels at 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 Hours and on Day 8 Post Dose	Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose	Baseline serum sodium value is the last measurement prior to dosing. Change from baseline is calculated as time point minus baseline.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Baseline and 0.5, 1, and 1.5 hours post dose	Participants Analyzed represents Full Analysis Set (FAS): All randomized patients who had at least 1 dose of study drug \& who had hepatic venous pressure gradient data at baseline.~The number of participants per arm is consistent for all categories of the data table.	mmHg	MEAN
PRIMARY	Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose	Baseline and 0.5, 1, and 1.5 hours post dose	Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug \& who had hepatic venous pressure gradient data at baseline. (Note: 2 patients were not included in the analysis due to protocol deviations.) The number of participants included in the calculation for each timepoint is noted in the category title.	mL/min	MEAN
PRIMARY	Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose	Baseline and 0.5, 1, and 1.5 hours post dose	Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug \& who had hepatic venous pressure gradient data at baseline.~The number of participants included in the calculation for each timepoint is noted in the category title.	mmHg	MEAN
PRIMARY	Change From Baseline in Blood Pressure at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose	Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose	Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication.~The number of participants per arm is consistent for all categories of the data table.	mmHg	MEAN
PRIMARY	Change From Baseline in Heart Rate at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose	Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose	Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication.~The number of participants per arm is consistent for all categories of the data table.	bpm	MEAN
SECONDARY	Change From Baseline in Serum Sodium Levels at 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 Hours and on Day 8 Post Dose	Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose	Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug \& who had hepatic venous pressure gradient data at baseline.~The number of participants included in the calculation for each timepoint is noted in the category title.	mEq/L	MEAN

Source ClinicalTrials.gov

Results by group183

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Regimen 1 Conivaptan 12.5 mg	Baseline	16.58	Standard Deviation 4.375	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Regimen 2 Conivaptan 25 mg	Baseline	18.33	Standard Deviation 4.750	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Regimen 3 Placebo	Baseline	15.80	Standard Deviation 6.601	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Regimen 1 Conivaptan 12.5 mg	Change at 0.5 Hours	0.33	Standard Deviation 1.080	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Regimen 2 Conivaptan 25 mg	Change at 0.5 Hours	0.11	Standard Deviation 1.318	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Regimen 3 Placebo	Change at 0.5 Hours	-0.10	Standard Deviation 0.224	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Regimen 1 Conivaptan 12.5 mg	Change at 1 Hour	0.50	Standard Deviation 1.844	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Regimen 2 Conivaptan 25 mg	Change at 1 Hour	0.56	Standard Deviation 1.357	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Regimen 3 Placebo	Change at 1 Hour	-0.60	Standard Deviation 0.418	mmHg
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose	Regimen 1 Conivaptan 12.5 mg	Change at 1.5 Hours	0.83	Standard Deviation 2.113	mmHg

1 to 10 of 183Source ClinicalTrials.gov

See all 183 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Regimen 1 Conivaptan 12.5 mg	6
Overall Study	STARTED	Regimen 2 Conivaptan 25 mg	9
Overall Study	STARTED	Regimen 3 Placebo	5
Overall Study	COMPLETED	Regimen 1 Conivaptan 12.5 mg	6
Overall Study	COMPLETED	Regimen 2 Conivaptan 25 mg	9
Overall Study	COMPLETED	Regimen 3 Placebo	5
Overall Study	NOT COMPLETED	Regimen 1 Conivaptan 12.5 mg	0
Overall Study	NOT COMPLETED	Regimen 2 Conivaptan 25 mg	0
Overall Study	NOT COMPLETED	Regimen 3 Placebo	0

Source ClinicalTrials.gov

Adverse events36

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	Atrial flutter	Cardiac disorders	Regimen 1 Conivaptan 12.5 mg	0	6
other	Atrial flutter	Cardiac disorders	Regimen 2 Conivaptan 25 mg	1	9
other	Atrial flutter	Cardiac disorders	Regimen 3 Placebo	0	5
other	Nausea	Gastrointestinal disorders	Regimen 1 Conivaptan 12.5 mg	0	6
other	Nausea	Gastrointestinal disorders	Regimen 2 Conivaptan 25 mg	1	9
other	Nausea	Gastrointestinal disorders	Regimen 3 Placebo	0	5
other	Vomiting	Gastrointestinal disorders	Regimen 1 Conivaptan 12.5 mg	0	6
other	Vomiting	Gastrointestinal disorders	Regimen 2 Conivaptan 25 mg	1	9
other	Vomiting	Gastrointestinal disorders	Regimen 3 Placebo	0	5
other	Polydipsia	Metabolism and nutrition disorders	Regimen 1 Conivaptan 12.5 mg	0	6

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regimen 1 Conivaptan 12.5 mg
Total, all-cause mortality	Regimen 2 Conivaptan 25 mg
Total, all-cause mortality	Regimen 3 Placebo
Total, other adverse events	Regimen 1 Conivaptan 12.5 mg	1	6
Total, other adverse events	Regimen 2 Conivaptan 25 mg	6	9
Total, other adverse events	Regimen 3 Placebo	0	5
Total, serious adverse events	Regimen 1 Conivaptan 12.5 mg	0	6
Total, serious adverse events	Regimen 2 Conivaptan 25 mg	2	9
Total, serious adverse events	Regimen 3 Placebo	0	5

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.

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