Trials / Completed
CompletedNCT03578809
A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 593 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction). The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MEDI6012 | MEDI6012 |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2018-06-05
- Primary completion
- 2021-01-18
- Completion
- 2021-01-18
- First posted
- 2018-07-06
- Last updated
- 2022-02-09
- Results posted
- 2022-02-09
Locations
37 sites across 10 countries: Brazil, Czechia, Hungary, Israel, Netherlands, Poland, Russia, Slovakia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03578809. Inclusion in this directory is not an endorsement.