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dalteparin

Phase 2

Venous Thromboembolism | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Apr 16, 2019

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
UNCONTROLLED
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00952380Fragmin for the Treatment of Acute VTE in Pediatric Cancer PatientsPHASE2 COMPLETED 38 — — Aug 1, 2009Mar 1, 2018Apr 16, 201926 United States, Norway +3
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Study Endpoints
Primary Endpoints
Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level
4 hours post-dose at each Day 1 to 7 in dose adjustment phase

Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported.

Secondary Endpoints
Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels
Day 1 to 7 in dose adjustment phase
Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)
Baseline up to 28 days after the last dose of study drug (up to Day 132)
Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
Baseline up to 28 days after the last dose of study drug (up to Day 132)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single ArmOTHERSingle arm open-label
Interventions
NameTypeDescription
dalteparinDRUGdalteparin subcutaneous injection
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Eligibility Criteria
Age RangeN/A — 18 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: \- Exclusion Criteria: \-

Countries:United StatesNorwayRussiaSloveniaSpain
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