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Vasopressin V2 Receptor Antagonist

Phase 2

Chronic Heart Failure | Small molecule | Cardiovascular |Sanofi|Last Updated: Jun 17, 2008

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment338
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00032747Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).PHASE2 COMPLETED 338Aug 1, 2001Feb 1, 2003Jun 17, 20089 United States, Canada +1
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Study Endpoints
Primary Endpoints
Clinical status at day 120.
Secondary Endpoints
NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Vasopressin V2 Receptor AntagonistDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites9

* Men or women with chronic heart failure (NYHA Class IIIB and IV). * Women must be post-menopausal or surgically sterilized; they cannot be pregnant or nursing. * Age 21 to 80 years. * Chronic heart failure of at least 3 months duration. For 2 months prior to screening, patients must have had sympt...

Countries:United StatesCanadaUnited Kingdom
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