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

May 8, 2016 updated by: LG Life Sciences

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: LC28-0126 Dose A
Drug: LC28-0126 Dose A
LC28-0126 Dose A
Experimental: LC28-0126 Dose B
Drug: LC28-0126 Dose B
LC28-0126 Dose B
Experimental: LC28-0126 Dose C
Drug: LC28-0126 Dose C
LC28-0126 Dose C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC of CK-MB for 72 hours post PCI
Time Frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC of Troponin I and CK for 72h post PCI
Time Frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Infarct size and myocardial function assessed by CMR and Echocardiogram
Time Frame: Day 4, 30
Day 4, 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

February 21, 2014

First Submitted That Met QC Criteria

February 21, 2014

First Posted (Estimate)

February 25, 2014

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 8, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-CYCL002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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