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Polidocanol Endovenous Microfoam

Phase 1

Varicose Veins | Small molecule | Cardiovascular |Boston Scientific Corporation|Trials Updated: Apr 21, 2021

Polidocanol Endovenous Microfoam target and mechanism

ModalitySmall molecule

Also known as Polidocanol Endovenous Microfoam (PEM)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Polidocanol Endovenous Microfoam clinical trials

Polidocanol Endovenous Microfoam · 1 trial · 1 indication

Phase 1 1
NCT01428076Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)Varicose Veins
COMPLETED21 Analytics
PHASE1COMPLETED
Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)
Varicose VeinsUnlock trial analytics

Study Endpoints

Primary Endpoints

Weight-adjusted Polidocanol Cmax (Serum)
pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose

Cmax measured and adjusted for weight

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
High Dose Polidocanol Endovenous MicrofoamEXPERIMENTAL -
Medium Dose Polidocanol Endovenous MicrofoamEXPERIMENTAL -

Interventions

NameTypeDescription
Polidocanol Endovenous Microfoam (PEM)DRUGPharmacokinetic comparison of different doses of drug
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female; age 18 to 75 years * Superficial venous disease where SFJ incompetence is the predominant source of reflux (reflux \> 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein * Expected ...

Countries:United States
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Frequently asked questions about Polidocanol Endovenous Microfoam

What is Polidocanol Endovenous Microfoam used for?

Polidocanol Endovenous Microfoam is being studied for the treatment of varicose veins, a cardiovascular condition. It is an investigational small molecule therapy that has been evaluated in a Phase 1 clinical trial. It is not described as approved for any use.

Who is developing Polidocanol Endovenous Microfoam?

Polidocanol Endovenous Microfoam is being developed by Boston Scientific Corporation, which trades under the ticker BSX. The company is the sponsor behind the clinical development program for this varicose vein treatment candidate.

What phase is Polidocanol Endovenous Microfoam in?

Polidocanol Endovenous Microfoam is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. It is an investigational agent and has not been established as an approved therapy for varicose veins.

What clinical trials is Polidocanol Endovenous Microfoam in?

Polidocanol Endovenous Microfoam has been studied in one completed Phase 1 trial, NCT01428076, titled a pharmacokinetic study of Polidocanol Endovenous Microfoam. That randomized, controlled trial enrolled 21 participants with varicose veins in the United States and included adults aged 18 years and older.

Is Polidocanol Endovenous Microfoam the same as PEM?

Yes, Polidocanol Endovenous Microfoam is also known as PEM. PEM is simply the abbreviated form of the full drug name used in trial titles and references, so searches for either term refer to the same investigational varicose vein therapy developed by Boston Scientific Corporation.