Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01428076 | Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM) | PHASE1 | COMPLETED | 21 | — | — | Aug 1, 2011 | Jan 1, 2012 | Apr 21, 2021 | 1 | United States |
Cmax measured and adjusted for weight
| Arm | Type | Description |
|---|---|---|
| High Dose Polidocanol Endovenous Microfoam | EXPERIMENTAL | - |
| Medium Dose Polidocanol Endovenous Microfoam | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Polidocanol Endovenous Microfoam (PEM) | DRUG | Pharmacokinetic comparison of different doses of drug |
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 ...