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NCT01428076 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)
A Phase 1 study of Varicose Veins, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01428076: Completed Phase 1 study of Varicose Veins, sponsored by Boston Scientific Corporation.
NCT01428076 is a Phase 1 study of Varicose Veins that has completed, run by Boston Scientific Corporation. The registered enrollment target is 21 participants, below the 167-participant average among 6 other Varicose Veins trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01428076, a Phase 1 study of Varicose Veins, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the pharmacokinetic profile of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an investigational treatment for varicose veins.
Primary Outcome
Cmax measured and adjusted for weight
Conditions Studied
Interventions
- DRUG Polidocanol Endovenous Microfoam (PEM)
Study Locations (1)
Florida
- Cardiovascular and Vein Center of Florida - Bradenton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT01428076 record still lists
NCT01428076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 167-participant average among 6 other Varicose Veins trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Varicose Veins appearing as the primary indexed condition, and to 1 intervention - of which Polidocanol Endovenous Microfoam (PEM) is the first listed.
NCT01428076 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01428076 about?
NCT01428076 is a clinical study titled "Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)". Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the pharmacokinetic profile of two different doses of an ...
What is the current status of trial NCT01428076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2011-08. Estimated completion is 2012-01.
What conditions does trial NCT01428076 study?
This clinical trial studies the following conditions: Varicose Veins.
What interventions are being tested in trial NCT01428076?
The interventions under investigation include: Polidocanol Endovenous Microfoam (PEM) (DRUG).
Who is sponsoring clinical trial NCT01428076?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01428076 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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