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conivaptan

Phase 3

Hyponatremia | Small molecule | Nephrology |Cumberland Pharmaceuticals Inc.|Last Updated: May 15, 2014

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment301
FDA Designations
No designations recorded
Clinical trial landscape

conivaptan · 7 trials · 5 indications

Phase 3 2Phase 2 2Phase 1 3
NCT00478192Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic HyponatremiaHyponatremia
COMPLETED50 Analytics
NCT00379847An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic HyponatremiaHyponatremia
COMPLETED251 Analytics
PHASE3COMPLETED
Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Hyponatremia
NCT0047819250
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PHASE3COMPLETED
An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
Hyponatremia
NCT00379847251
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Study Endpoints
Primary Endpoints
Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.
Baseline and 48 hours

Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1. Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment. Change is calculated as Hour 48 - Baseline.

Baseline-adjusted change in AUC for serum sodium
96 Hours
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.

Change from baseline in respiratory Visual analog Scale (VAS)
48 hours
Assess the effect of severe hepatic impairment on the plasma drug concentration of conivaptan through analysis of blood samples
5 days
Measure PK and protein binding of conivaptan
5 days
Secondary Endpoints
Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment
Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48
Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium
48 Hours
Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours
48 Hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Regimen 1 Conivaptan QDEXPERIMENTAL20 mg conivaptan once a day
Regimen 2 Conivaptan BIDEXPERIMENTAL20 mg conivaptan two times a day
Regimen 3 PlaceboPLACEBO_COMPARATOR -
1EXPERIMENTALLower dose
2EXPERIMENTALHigher dose
Regimen 1 Conivaptan 12.5 mgEXPERIMENTALConivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
Regimen 2 Conivaptan 25 mgEXPERIMENTALConivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
3EXPERIMENTALMiddle dose
4EXPERIMENTALHigh dose
Subjects with severe hepatic impairmentEXPERIMENTAL -
Subjects with normal hepatic functionACTIVE_COMPARATOR -
1. Mild Renal Function Impaired SubjectsEXPERIMENTAL -
2. Moderate Renal Function Impaired SubjectsEXPERIMENTAL -
3. Subjects with Normal Renal FunctionEXPERIMENTAL -
1. Mildly Hepatic Impaired SubjectsEXPERIMENTAL -
2. Moderately Hepatic Impaired SubjectsEXPERIMENTAL -
3. Subjects with Normal Hepatic FunctionEXPERIMENTAL -
Interventions
NameTypeDescription
ConivaptanDRUGpremix bag
PlaceboDRUGpremix bag
conivaptan hydrochlorideDRUGIntravenous
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Euvolemic or hypervolemic (edematous) based on clinical presentation * Serum sodium between 115 and 130mEq/L at baseline Exclusion Criteria: * Clinical presentation of volume depletion or dehydration

Countries:United StatesIndiaIsraelSouth AfricaSpain
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