A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients
Sponsor
Cumberland Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00592475
Collaborator
(none)
20
1
3
11
1.8
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double Blind, Placebo Controlled, Dose Escalation Study to Assess the Safety and Effects of Intravenous Conivaptan on the Hepatic Hemodynamic Response in Stable Euvolemic or Hypervolemic Cirrhotic Patients
Study Start Date
:
Dec 1, 2007
Actual Primary Completion Date
:
Nov 1, 2008
Actual Study Completion Date
:
Nov 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Regimen 1 Conivaptan 12.5 mg Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours |
Drug: conivaptan
IV
|
| Experimental: Regimen 2 Conivaptan 25 mg Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours |
Drug: conivaptan
IV
|
| Placebo Comparator: Regimen 3 Placebo Placebo continuous intravenous infusion over 6.5 hours |
Drug: Placebo
IV
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and appropriate privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable)
-
Subject is euvolemic or hypervolemic (edematous) secondary to cirrhosis
-
Subject has clinical evidence of portal hypertension by the presence of esophageal varices, ascites or both
Exclusion Criteria:
-
Clinical evidence of volume depletion or dehydration
-
Subject has a history of bleeding from esophageal varices within three months before the start of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barcelona | Spain |
Sponsors and Collaborators
- Cumberland Pharmaceuticals
Investigators
- Study Director: Art Wheeler, MD, Cumberland Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00592475
Other Study ID Numbers:
- 087-CL-089
- 2007-001661-15
First Posted:
Jan 14, 2008
Last Update Posted:
May 15, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Cumberland Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo |
|---|---|---|---|
| Arm/Group Description | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours | Placebo continuous intravenous infusion over 6.5 hours |
| Period Title: Overall Study | |||
| STARTED | 6 | 9 | 5 |
| COMPLETED | 6 | 9 | 5 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours | Placebo continuous intravenous infusion over 6.5 hours | Total of all reporting groups |
| Overall Participants | 6 | 9 | 5 | 20 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
63.7
(8.52)
|
60.0
(9.72)
|
55.2
(7.19)
|
59.9
(8.95)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
3
50%
|
2
22.2%
|
0
0%
|
5
25%
|
| Male |
3
50%
|
7
77.8%
|
5
100%
|
15
75%
|
| Race/Ethnicity, Customized (Number) [Number] | ||||
| White |
6
100%
|
9
100%
|
5
100%
|
20
100%
|
| Underlying Cause of Hyponatremia (Number) [Number] | ||||
| Euvolemic - Cirrhosis |
1
16.7%
|
1
11.1%
|
1
20%
|
3
15%
|
| Euvolemic - Not Hyponatremia |
2
33.3%
|
1
11.1%
|
1
20%
|
4
20%
|
| Euvolemic - Other |
1
16.7%
|
0
0%
|
0
0%
|
1
5%
|
| Hypervolemic - Cirrhosis |
2
33.3%
|
3
33.3%
|
3
60%
|
8
40%
|
| Hypervolemic - Not Hyponatremia |
0
0%
|
3
33.3%
|
0
0%
|
3
15%
|
| Hypervolemic - Other |
0
0%
|
1
11.1%
|
0
0%
|
1
5%
|
Outcome Measures
| Title | Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose |
|---|---|
| Description | Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration. |
| Time Frame | Baseline and 0.5, 1, and 1.5 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo |
|---|---|---|---|
| Arm/Group Description | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours | Placebo continuous intravenous infusion over 6.5 hours |
| Measure Participants | 6 | 9 | 5 |
| Baseline |
16.58
(4.375)
|
18.33
(4.750)
|
15.80
(6.601)
|
| Change at 0.5 Hours |
0.33
(1.080)
|
0.11
(1.318)
|
-0.10
(0.224)
|
| Change at 1 Hour |
0.50
(1.844)
|
0.56
(1.357)
|
-0.60
(0.418)
|
| Change at 1.5 Hours |
0.83
(2.113)
|
0.83
(1.732)
|
-0.10
(1.294)
|
| Title | Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose |
|---|---|
| Description | Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration. |
| Time Frame | Baseline and 0.5, 1, and 1.5 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo |
|---|---|---|---|
| Arm/Group Description | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours | Placebo continuous intravenous infusion over 6.5 hours |
| Measure Participants | 6 | 9 | 5 |
| Baseline (N= 4; 9; 5) |
581.0
(77.49)
|
1182.2
(530.56)
|
649.6
(300.44)
|
| Change at 0.5 Hours (N= 4; 9; 5) |
53.5
(161.30)
|
-74.1
(558.58)
|
73.8
(196.75)
|
| Change at 1 Hour (N= 4; 9; 4) |
1.3
(160.23)
|
-70.0
(318.35)
|
-67.5
(270.27)
|
| Change at 1.5 Hours (N= 4; 9; 5) |
15.8
(60.26)
|
-96.0
(390.96)
|
40.8
(154.33)
|
| Title | Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose |
|---|---|
| Description | Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration. |
| Time Frame | Baseline and 0.5, 1, and 1.5 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo |
|---|---|---|---|
| Arm/Group Description | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours | Placebo continuous intravenous infusion over 6.5 hours |
| Measure Participants | 6 | 9 | 5 |
| Baseline (N= 6; 9; 5) |
88.3
(11.89)
|
90.3
(7.79)
|
84.6
(13.63)
|
| Change at 0.5 Hours (N= 6; 8; 5) |
-6.2
(9.66)
|
3.6
(9.97)
|
2.6
(4.72)
|
| Change at 1.0 Hour (N= 6; 9; 5) |
-4.2
(9.28)
|
5.7
(13.18)
|
7.8
(10.92)
|
| Change at 1.5 Hours (N= 6; 9; 5) |
0
(7.77)
|
8.8
(11.39)
|
3.4
(6.31)
|
| Title | 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 |
|---|---|
| Description | Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo |
|---|---|---|---|
| Arm/Group Description | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours | Placebo continuous intravenous infusion over 6.5 hours |
| Measure Participants | 6 | 9 | 5 |
| Systolic Blood Pressure- Baseline |
112.2
(13.73)
|
115.0
(14.42)
|
112.8
(12.03)
|
| Systolic Blood Pressure- Change at 0.5 Hours |
5.3
(13.29)
|
5.2
(9.86)
|
12.8
(17.54)
|
| Systolic Blood Pressure- Change at 1 Hour |
5.5
(17.62)
|
13.9
(14.12)
|
6.8
(21.39)
|
| Systolic Blood Pressure- Change at 1.5 Hours |
7.8
(20.90)
|
7.2
(12.59)
|
1.2
(16.27)
|
| Systolic Blood Pressure- Change at 2.5 Hours |
-2.5
(9.65)
|
-3.8
(8.15)
|
-2.6
(18.69)
|
| Systolic Blood Pressure- Change at 3.5 Hours |
-6.0
(8.94)
|
-6.3
(14.83)
|
-11.4
(10.36)
|
| Systolic Blood Pressure- Change at 4.5 Hours |
-6.2
(12.91)
|
-17.1
(11.54)
|
-8.2
(2.95)
|
| Systolic Blood Pressure- Change at 5.5 Hours |
-6.3
(7.20)
|
-8.7
(14.94)
|
-7.6
(2.30)
|
| Systolic Blood Pressure- Change at 6.5 Hours |
-8.8
(10.65)
|
-9.7
(7.73)
|
-9.4
(15.47)
|
| Systolic Blood Pressure- Change at 9 Hours |
-5.5
(15.35)
|
1.9
(11.46)
|
-7.2
(12.38)
|
| Systolic Blood Pressure- Change at 12 Hours |
-14.0
(21.48)
|
-7.8
(15.97)
|
-5.8
(19.41)
|
| Systolic Blood Pressure- Change at 24 Hours |
-10.8
(15.21)
|
-7.8
(12.53)
|
-11.0
(5.00)
|
| Systolic Blood Pressure- Change at 8 Days |
-11.5
(7.87)
|
-7.8
(10.87)
|
-5.4
(8.41)
|
| Diastolic Blood Pressure- Baseline |
60.3
(10.65)
|
66.3
(9.10)
|
71.6
(8.11)
|
| Diastolic Blood Pressure- Change at 0.5 Hours |
4.5
(3.27)
|
4.9
(6.83)
|
1.8
(6.10)
|
| Diastolic Blood Pressure- Change at 1 Hour |
7.3
(5.57)
|
5.1
(6.45)
|
3.6
(9.84)
|
| Diastolic Blood Pressure- Change at 1.5 Hours |
9.2
(5.04)
|
5.7
(7.04)
|
4.0
(11.98)
|
| Diastolic Blood Pressure- Change at 2.5 Hours |
2.2
(4.83)
|
-2.1
(6.21)
|
-3.2
(12.26)
|
| Diastolic Blood Pressure- Change at 3.5 Hours |
1.0
(2.28)
|
-0.9
(12.00)
|
-6.8
(5.54)
|
| Diastolic Blood Pressure- Change at 4.5 Hours |
-2.5
(3.27)
|
-6.3
(7.45)
|
-6.4
(7.54)
|
| Diastolic Blood Pressure- Change at 5.5 Hours |
2.7
(3.93)
|
-4.2
(7.79)
|
-9.8
(10.03)
|
| Diastolic Blood Pressure- Change at 6.5 Hours |
-1.0
(7.13)
|
-4.7
(6.20)
|
-7.6
(11.01)
|
| Diastolic Blood Pressure- Change at 9 Hours |
5.0
(5.62)
|
0.3
(4.82)
|
-4.4
(10.01)
|
| Diastolic Blood Pressure- Change at 12 Hours |
0.0
(12.68)
|
-3.3
(6.42)
|
-6.0
(13.06)
|
| Diastolic Blood Pressure- Change at 24 Hours |
-0.5
(7.34)
|
-5.1
(5.56)
|
-11.4
(10.14)
|
| Diastolic Blood Pressure- Change at 8 Days |
-3.0
(6.72)
|
-5.0
(9.55)
|
-7.6
(7.37)
|
| Title | 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 |
|---|---|
| Description | Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo |
|---|---|---|---|
| Arm/Group Description | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours | Placebo continuous intravenous infusion over 6.5 hours |
| Measure Participants | 6 | 9 | 5 |
| Baseline |
69.0
(19.30)
|
77.3
(22.86)
|
72.0
(25.52)
|
| Change at 0.5 Hours |
0.7
(8.33)
|
-6.0
(11.88)
|
-2.0
(8.22)
|
| Change at 1 Hour |
3.0
(7.92)
|
-5.4
(9.25)
|
-2.4
(7.30)
|
| Change at 1.5 Hours |
2.3
(8.66)
|
-4.0
(9.73)
|
-3.2
(8.29)
|
| Change at 2.5 Hours |
-0.3
(3.27)
|
-8.6
(11.17)
|
0.4
(9.10)
|
| Change at 3.5 Hours |
1.3
(7.66)
|
-1.4
(14.34)
|
2.8
(7.56)
|
| Change at 4.5 Hours |
3.3
(5.65)
|
-1.2
(15.81)
|
4.0
(7.35)
|
| Change at 5.5 Hours |
4.3
(5.35)
|
-2.9
(14.14)
|
3.6
(5.18)
|
| Change at 6.5 Hours |
8.0
(4.56)
|
-4.0
(13.08)
|
3.4
(7.23)
|
| Change at 9 Hours |
4.8
(10.21)
|
-0.9
(12.32)
|
1.8
(11.48)
|
| Change at 12 Hours |
1.8
(8.84)
|
9.0
(21.46)
|
3.8
(15.16)
|
| Change at 24 Hours |
1.2
(6.01)
|
2.7
(17.00)
|
3.6
(7.37)
|
| Change at 8 Days |
0.7
(10.31)
|
-7.1
(20.87)
|
-0.8
(9.18)
|
| Title | 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 |
|---|---|
| Description | Baseline serum sodium value is the last measurement prior to dosing. Change from baseline is calculated as time point minus baseline. |
| Time Frame | Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo |
|---|---|---|---|
| Arm/Group Description | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours | Placebo continuous intravenous infusion over 6.5 hours |
| Measure Participants | 6 | 9 | 5 |
| Baseline (N= 6; 9; 5) |
137.3
(3.08)
|
137.1
(2.80)
|
131.2
(6.30)
|
| Change at 0.5 Hours (N= 6; 9; 5) |
-1.3
(3.01)
|
-1.1
(2.71)
|
-0.8
(1.64)
|
| Change at 1 Hour (N= 6; 9; 5) |
-0.3
(3.72)
|
0.9
(2.80)
|
-1.8
(1.30)
|
| Change at 2.5 Hours (N= 6; 9; 5) |
1.8
(2.56)
|
0.2
(1.72)
|
0.0
(3.61)
|
| Change at 4 Hours (N= 6; 9; 5) |
-2.2
(5.19)
|
-1.0
(1.87)
|
-3.6
(1.67)
|
| Change at 6.5 Hours (N= 6; 9; 5) |
-1.2
(2.32)
|
1.3
(4.33)
|
-2.4
(2.07)
|
| Change at 9 Hours (N= 5; 9; 5) |
-2.6
(3.05)
|
0.8
(3.46)
|
-2.4
(2.97)
|
| Change at 12 Hours (N= 6; 9; 5) |
-3.7
(2.66)
|
0.1
(3.06)
|
-2.2
(2.28)
|
| Change at 24 Hours (N= 6; 9; 5) |
-1.5
(2.88)
|
0.1
(1.76)
|
-2.0
(3.16)
|
| Change at 8 Days (N= 6; 9; 5) |
-2.3
(3.20)
|
0.1
(3.59)
|
2.0
(1.00)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo | |||
| Arm/Group Description | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours | Placebo continuous intravenous infusion over 6.5 hours | |||
All Cause Mortality |
||||||
| Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 2/9 (22.2%) | 0/5 (0%) | |||
| Cardiac disorders | ||||||
| Atrial tachycardia | 0/6 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Infections and infestations | ||||||
| Urinary tract infection | 0/6 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Nervous system disorders | ||||||
| Hepatic encephalopathy | 0/6 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Regimen 1 Conivaptan 12.5 mg | Regimen 2 Conivaptan 25 mg | Regimen 3 Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/6 (16.7%) | 6/9 (66.7%) | 0/5 (0%) | |||
| Cardiac disorders | ||||||
| Atrial flutter | 0/6 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 0/6 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Vomiting | 0/6 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Polydipsia | 0/6 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back Pain | 0/6 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Nervous system disorders | ||||||
| Dizziness | 1/6 (16.7%) | 0/9 (0%) | 0/5 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Productive cough | 0/6 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dry skin | 0/6 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Vascular disorders | ||||||
| Phlebitis | 0/6 (0%) | 2/9 (22.2%) | 0/5 (0%) | |||
Limitations/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.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Senior Medical Director, Medical Affairs |
|---|---|
| Organization | Astellas Pharma Global Development |
| Phone | |
| clinicaltrials@us.astellas.com |
Responsible Party:
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00592475
Other Study ID Numbers:
- 087-CL-089
- 2007-001661-15
First Posted:
Jan 14, 2008
Last Update Posted:
May 15, 2014
Last Verified:
Apr 1, 2014