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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT02070471
First received: February 21, 2014
Last updated: May 8, 2016
Last verified: September 2015

February 21, 2014
May 8, 2016
January 2014
June 2015   (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.
 
Completed
60
Not Provided
June 2015   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT02070471
LG-CYCL002
Not Provided
Not Provided
Not Provided
LG Life Sciences
LG Life Sciences
Not Provided
Not Provided
LG Life Sciences
September 2015

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