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conivaptan

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment301
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00478192Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic HyponatremiaPHASE3 COMPLETED 50 — — Apr 1, 2007Aug 1, 2008May 15, 201426 United States, India
NCT00379847An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic HyponatremiaPHASE3 COMPLETED 251 — — Feb 1, 2004Jun 1, 2005May 2, 201428 United States, Israel +1
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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
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
Interventions
NameTypeDescription
ConivaptanDRUGpremix bag
PlaceboDRUGpremix bag
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Eligibility Criteria
Age Range18 Years — 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 Africa
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