Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by LG Life Sciences
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT02070471
First received: February 21, 2014
Last updated: March 13, 2014
Last verified: March 2014

February 21, 2014
March 13, 2014
January 2014
December 2014   (final data collection date for primary outcome measure)
AUC of CK-MB for 72 hours post PCI [ Time Frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02070471 on ClinicalTrials.gov Archive Site
  • AUC of Troponin I and CK for 72h post PCI [ Time Frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h ] [ Designated as safety issue: No ]
  • Infarct size and myocardial function assessed by CMR and Echocardiogram [ Time Frame: Day 4, 30 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intravenous Single Injection LC28-0126 Immediately Before PCI (Percutaneous Coronary Intervention) in Patients With STEMI(ST-segment Elevation Myocardial Infarction)

Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before PCI (Percutaneous Coronary Intervention) in Patients with STEMI (ST-segment Elevation Myocardial Infarction)

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
ST-segment Elevation Myocardial Infarction
  • Drug: Placebo
    Placebo
  • Drug: LC28-0126 Dose A
    LC28-0126 Dose A
  • Drug: LC28-0126 Dose B
    LC28-0126 Dose B
  • Drug: LC28-0126 Dose C
    LC28-0126 Dose C
  • Experimental: LC28-0126 Dose A
    LC28-0126 Dose A
    Intervention: Drug: LC28-0126 Dose A
  • Experimental: LC28-0126 Dose B
    LC28-0126 Dose B
    Intervention: Drug: LC28-0126 Dose B
  • Experimental: LC28-0126 Dose C
    LC28-0126 Dose C
    Intervention: Drug: LC28-0126 Dose C
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 20 and 75
  • Within 12 hours after the onset of chest pain
  • ST-segment elevation of more than 0.1 mV in two contiguous leads or new LBBB(left bundle-branch block) patients
  • Signed for written informed consent

Exclusion Criteria:

  • Left Main disease
  • Multi-vessel disease
Both
20 Years to 75 Years
No
Korea, Republic of
 
NCT02070471
LG-CYCL002
Not Provided
LG Life Sciences
LG Life Sciences
Not Provided
Not Provided
LG Life Sciences
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP