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Odiparcil

Phase 2

Deep Vein Thrombosis | Small molecule | Cardiovascular |GSK plc|Last Updated: May 2, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment961

FDA Designations

No designations recorded

Clinical trial landscape

Odiparcil · 1 trial · 4 indications

Phase 2 1
NCT00244725Odiparcil For The Prevention Of Venous ThromboembolismDeep Vein Thrombosis
COMPLETED961 Analytics
PHASE2COMPLETED
Odiparcil For The Prevention Of Venous Thromboembolism
Deep Vein ThrombosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment
Up to Visit 7 (10 ± 2 days of treatment)

Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment.

Secondary Endpoints

Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment
Up to 12 days
Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment
Up to 12 days
Percentage of Participants With PE Over 10 ± 2 Days of Treatment
Up to 12 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposePREVENTION

Interventions

NameTypeDescription
OdiparcilDRUG -
WarfarinDRUG -
CoumadinDRUG -
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Eligibility Criteria

Age Range35 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites101

Inclusion Criteria: * Women must be unable to have children. * Will have a total knee replacement. Exclusion Criteria: * Allergic to any X-ray dye. * Allergies or reactions to warfarin or coumadin. * Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT). * On anticoagulation therapy...

Countries:United StatesAustraliaBrazilCanadaIndiaIsraelLatviaLithuaniaPolandRussiaSouth AfricaUkraineUnited Kingdom
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Frequently asked questions about Odiparcil

What is Odiparcil used for?

Odiparcil is an investigational small molecule being studied for the prevention of venous thromboembolism, including deep vein thrombosis and pulmonary embolism. It is also being evaluated in patients with atrial fibrillation. The drug is in Phase 2 clinical development and is not approved for any use.

Who makes Odiparcil?

Odiparcil is being developed by GSK plc, a global biopharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The company is conducting clinical research to evaluate the drug's safety and efficacy in preventing venous thromboembolism.

What phase is Odiparcil in?

Odiparcil is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to assess its potential in preventing venous thromboembolism.

What clinical trials is Odiparcil in?

Odiparcil has one completed Phase 2 clinical trial registered as NCT00244725, titled 'Odiparcil For The Prevention Of Venous Thromboembolism.' The trial enrolled 961 participants across multiple countries, including the United States, Australia, Brazil, Canada, India, Israel, and the United Kingdom.

Is Odiparcil the same as any other drug?

No alternative names for Odiparcil have been reported. The drug is identified by its single name, Odiparcil, in clinical trial registries and research documentation.