Drugs / Semuloparin
Semuloparin
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT01567904 | May → Jul 2012 | — | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT00331838 | May 2006 → Jun 2007 | venous thromboembolism | Sanofi | Completed | No outcome recorded |
| Phase 37 trials · 3 met primary · 3 missed | ||||||
| Phase 3 | NCT00721760 | Jul 2008 → Oct 2009 | venous thromboembolism | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00718224 | Jul 2008 → May 2009 | venous thromboembolism | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00714597 | Jul 2008 → Mar 2009 | venous thromboembolism | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT00694382 | Jun 2008 → Nov 2010 | cancer, venous thromboembolism | Sanofi | Completed | Met primary |
| Phase 3 | NCT00697099 | Jun 2008 → Jun 2009 | venous thromboembolism | Sanofi | Completed | Met primary |
| Phase 3 | NCT00709904 | Jun 2008 → Jan 2010 | venous thromboembolism | Sanofi | Completed | Met primary |
| Phase 3 | NCT00679588 | Apr 2008 → Aug 2010 | venous thromboembolism | Sanofi | Completed | Missed primary |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Semuloparin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00714597 ↗ |
| Known as | AVE5026 | “AVE5026” NCT00714597 ↗ |
| Known as | Semuloparin sodium | “The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of...” NCT00679588 ↗7“Extension treatment with Semuloparin sodium 20 mg (10 mg if SRI) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days.” NCT00709904 ↗ “Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective knee replacement surgery.” NCT00718224 ↗ “Semuloparin sodium 5 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days” NCT00331838 ↗ “once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo” NCT00694382 ↗ “Semuloparin sodium (AVE5026)” NCT00714597 ↗ |
| Action | Inhibit | “with a novel anti-thrombotic profile resulting from high anti-factor (F)Xa activity and residual anti-FIIa activity” PMID 19187076 ↗ Jan 2009 |
| Modality | Other / unclassified | “AVE5026 is a new hemisynthetic ultra-low-molecular-weight heparin” PMID 19187076 ↗ Jan 2009 |
| Route | Subcutaneous | “Subcutaneous injection” NCT00331838 ↗ |