A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of danegaptide in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention

Trial Profile

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of danegaptide in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention

Completed
Phase of Trial: Phase II

Latest Information Update: 02 Mar 2016

At a glance

  • Drugs Danegaptide (Primary)
  • Indications Cardiovascular disorders; Myocardial infarction; Myocardial reperfusion injury
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Zealand Pharma
  • Most Recent Events

    • 02 Mar 2016 According to a Zealand Pharma media release, the company announced top line results from this phase II Proof-of-Concept trial of danegaptide for the protection against cardiac reperfusion injuries in patients with an acute myocardial infarction.
    • 02 Mar 2016 Primary endpoint [Myocardial Salvage Index [ Time Frame: 3 months ] [ Designated as safety issue: No ] Myocardial Salvage Index as assessed by MRI and calculated as the difference between myocardial volume at risk and final infarct size in relation to myocardial volume at riskhas not been met. (Myocardial Salvage Index)] has not been met.
    • 14 Jan 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
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