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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001661-15 | EudraCT Number |
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To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic response in patients with cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen 1 Conivaptan 12.5 mg | Experimental | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours |
|
| Regimen 2 Conivaptan 25 mg | Experimental | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours |
|
| Regimen 3 Placebo | Placebo Comparator | Placebo continuous intravenous infusion over 6.5 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conivaptan | Drug | IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 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. | Baseline and 0.5, 1, and 1.5 hours post dose |
| Change From Baseline in Hepatic Blood Flow (HBF) at 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. | Baseline and 0.5, 1, and 1.5 hours post dose |
| Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 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. | Baseline and 0.5, 1, and 1.5 hours post dose |
| 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 | Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration. | 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 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 | Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 serum sodium value is the last measurement prior to dosing. Change from baseline is calculated as time point minus baseline. | Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Art Wheeler, MD | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barcelona | Spain |
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| Label | URL |
|---|---|
| (Link to Prescribing Information) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Regimen 1 Conivaptan 12.5 mg | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours |
| FG001 | Regimen 2 Conivaptan 25 mg | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours |
| FG002 | Regimen 3 Placebo | Placebo continuous intravenous infusion over 6.5 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regimen 1 Conivaptan 12.5 mg | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours |
| BG001 | Regimen 2 Conivaptan 25 mg | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and 0.5, 1, and 1.5 hours post dose |
|
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Treatment-Emergent Adverse Event (TEAE) is an event that occurred after the first dose of study drug through 24 hours after the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regimen 1 Conivaptan 12.5 mg | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial tachycardia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Director, Medical Affairs | Astellas Pharma Global Development | clinicaltrials@us.astellas.com |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C106389 | conivaptan |
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| Placebo |
| Drug |
IV |
|
| BG002 | Regimen 3 Placebo | Placebo continuous intravenous infusion over 6.5 hours |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
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| Underlying Cause of Hyponatremia | Patients in the "Not hyponatremia" categories had serum sodium levels of 135-140mEq/L. Patients in the "Other" categories had Diuretic treatment. | Number | Participants |
|
Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours |
| OG002 | Regimen 3 Placebo | Placebo continuous intravenous infusion over 6.5 hours |
|
|
| Primary | Change From Baseline in Hepatic Blood Flow (HBF) at 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. | 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. | Posted | Mean | Standard Deviation | mL/min | Baseline and 0.5, 1, and 1.5 hours post dose |
|
|
|
| Primary | Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and 0.5, 1, and 1.5 hours post dose |
|
|
|
| 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 | Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration. | 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. | Posted | Mean | Standard Deviation | mmHg | 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 |
|
|
|
| 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 | Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration. | 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. | Posted | Mean | Standard Deviation | bpm | 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 |
|
|
|
| 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 serum sodium value is the last measurement prior to dosing. Change from baseline is calculated as time point minus baseline. | 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. | Posted | Mean | Standard Deviation | mEq/L | Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Regimen 2 Conivaptan 25 mg | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours | 2 | 9 | 6 | 9 |
| EG002 | Regimen 3 Placebo | Placebo continuous intravenous infusion over 6.5 hours | 0 | 5 | 0 | 5 |
| Urinary tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
Institute and/or Principal Investigator may publish trial data generated from the Study. Sponsor must receive the manuscript 60 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
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| Change at 1 Hour (N= 4; 9; 4) |
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| Change at 1.5 Hours (N= 4; 9; 5) |
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| Change at 1.0 Hour (N= 6; 9; 5) |
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| Change at 1.5 Hours (N= 6; 9; 5) |
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| Systolic Blood Pressure- Change at 1 Hour |
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| Systolic Blood Pressure- Change at 1.5 Hours |
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| Systolic Blood Pressure- Change at 2.5 Hours |
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| Systolic Blood Pressure- Change at 3.5 Hours |
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| Systolic Blood Pressure- Change at 4.5 Hours |
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| Systolic Blood Pressure- Change at 5.5 Hours |
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| Systolic Blood Pressure- Change at 6.5 Hours |
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| Systolic Blood Pressure- Change at 9 Hours |
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| Systolic Blood Pressure- Change at 12 Hours |
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| Systolic Blood Pressure- Change at 24 Hours |
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| Systolic Blood Pressure- Change at 8 Days |
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| Diastolic Blood Pressure- Baseline |
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| Diastolic Blood Pressure- Change at 0.5 Hours |
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| Diastolic Blood Pressure- Change at 1 Hour |
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| Diastolic Blood Pressure- Change at 1.5 Hours |
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| Diastolic Blood Pressure- Change at 2.5 Hours |
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| Diastolic Blood Pressure- Change at 3.5 Hours |
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| Diastolic Blood Pressure- Change at 4.5 Hours |
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| Diastolic Blood Pressure- Change at 5.5 Hours |
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| Diastolic Blood Pressure- Change at 6.5 Hours |
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| Diastolic Blood Pressure- Change at 9 Hours |
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| Diastolic Blood Pressure- Change at 12 Hours |
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| Diastolic Blood Pressure- Change at 24 Hours |
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| Diastolic Blood Pressure- Change at 8 Days |
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| Change at 1 Hour |
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| Change at 1.5 Hours |
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| Change at 2.5 Hours |
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| Change at 3.5 Hours |
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| Change at 4.5 Hours |
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| Change at 5.5 Hours |
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| Change at 6.5 Hours |
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| Change at 9 Hours |
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| Change at 12 Hours |
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| Change at 24 Hours |
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| Change at 8 Days |
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| Change at 1 Hour (N= 6; 9; 5) |
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| Change at 2.5 Hours (N= 6; 9; 5) |
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| Change at 4 Hours (N= 6; 9; 5) |
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| Change at 6.5 Hours (N= 6; 9; 5) |
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| Change at 9 Hours (N= 5; 9; 5) |
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| Change at 12 Hours (N= 6; 9; 5) |
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| Change at 24 Hours (N= 6; 9; 5) |
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| Change at 8 Days (N= 6; 9; 5) |
|