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

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ClinicalTrials.gov Identifier: NCT00592475
Recruitment Status : Completed
First Posted : January 14, 2008
Results First Posted : September 28, 2010
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

January 2, 2008
January 14, 2008
May 24, 2010
September 28, 2010
May 15, 2014
December 2007
November 2008   (Final data collection date for primary outcome measure)
  • Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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 ]

    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 [ 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 ]

    Change from baseline is calculated as time point minus baseline.

    Baseline procedures were performed prior to study drug administration.

Hemodynamic parameters including hepatic venous pressure gradient (HVPG), hepatic blood flow (HBF), mean arterial pressure (MAP), Heartrate, Blood pressure, Serum sodium and safety (physical exam, ECG, lab measurements, urinalysis and adverse events) [ Time Frame: Baseline to 8 days ]
Complete list of historical versions of study NCT00592475 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 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.

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Not Provided
Not Provided
 
A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Liver Cirrhosis
  • Drug: conivaptan
    IV
  • Drug: Placebo
    IV
  • Experimental: Regimen 1 Conivaptan 12.5 mg
    Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
    Intervention: Drug: conivaptan
  • Experimental: Regimen 2 Conivaptan 25 mg
    Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
    Intervention: Drug: conivaptan
  • Placebo Comparator: Regimen 3 Placebo
    Placebo continuous intravenous infusion over 6.5 hours
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
November 2008
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00592475
087-CL-089
2007-001661-15 ( EudraCT Number )
No
Not Provided
Not Provided
Cumberland Pharmaceuticals
Cumberland Pharmaceuticals
Not Provided
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc.
Cumberland Pharmaceuticals
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP