Recent Updates
Recently added Catalysts

Polidocanol Endovenous Microfoam

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

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

Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Polidocanol Endovenous Microfoam

What is Polidocanol Endovenous Microfoam used for?

Polidocanol Endovenous Microfoam is used for the treatment of varicose veins. It is a small molecule therapy in the cardiovascular therapeutic area, administered as an endovenous microfoam. The drug is being developed by Boston Scientific Corporation for this vascular condition.

Who makes Polidocanol Endovenous Microfoam?

Boston Scientific Corporation (BSX) is the developer of Polidocanol Endovenous Microfoam. The company is conducting clinical research on this investigational drug for the treatment of varicose veins. Boston Scientific is responsible for the drug's development program.

What phase is Polidocanol Endovenous Microfoam in?

Polidocanol Endovenous Microfoam is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 study has been completed, with a total of 21 participants enrolled in the clinical trial.

What clinical trials is Polidocanol Endovenous Microfoam in?

Polidocanol Endovenous Microfoam has one completed clinical trial, identified as NCT01428076. This Phase 1 study was a pharmacokinetic trial of the drug in patients with varicose veins. The trial enrolled 21 participants in the United States and was a controlled, randomized study.

Is Polidocanol Endovenous Microfoam the same as polidocanol?

Polidocanol Endovenous Microfoam is a specific formulation of polidocanol, delivered as a microfoam for endovenous use. The drug is being studied for varicose veins, and the clinical trial NCT01428076 evaluates this particular microfoam formulation. The drug name reflects its unique delivery method.