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dalteparin

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

dalteparin · 1 trial · 1 indication

Phase 2 1
NCT00952380Fragmin for the Treatment of Acute VTE in Pediatric Cancer PatientsVenous Thromboembolism
COMPLETED38 Analytics
PHASE2COMPLETED
Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
Venous Thromboembolism
NCT0095238038
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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 to 18 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: \- Exclusion Criteria: \-

Countries:United StatesNorwayRussiaSloveniaSpain
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Frequently asked questions about dalteparin

What is dalteparin used for?

Dalteparin is used for the treatment of venous thromboembolism (VTE), specifically in pediatric cancer patients with acute VTE. It is being investigated as a therapeutic option for this condition, with clinical development currently in Phase 2.

Who makes dalteparin?

Dalteparin is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical development for the treatment of venous thromboembolism.

What phase is dalteparin in?

Dalteparin is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied for the treatment of venous thromboembolism in pediatric cancer patients.

What clinical trials is dalteparin in?

Dalteparin has one completed clinical trial, NCT00952380, titled 'Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients.' This Phase 2 study enrolled 38 participants with venous thromboembolism and was conducted in the United States, Norway, Russia, Slovenia, and Spain.

Is dalteparin the same as Fragmin?

Yes, dalteparin is also known as Fragmin. The clinical trial NCT00952380 uses the name Fragmin in its title, confirming that these names refer to the same drug being developed by Pfizer for venous thromboembolism.