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

LG Life Sciences

Status and phase: Completed; Phase 2

Conditions: ST-segment Elevation Myocardial Infarction

Treatments: Drug: Placebo; Drug: LC28-0126 Dose A; Drug: LC28-0126 Dose B; Drug: LC28-0126 Dose C

Study type: Interventional

Funder types: Industry

Identifiers

NCT02070471

LG-CYCL002

Details and patient eligibility

About

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)

Enrollment: 60 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

LC28-0126 Dose A

Experimental group

Description:

LC28-0126 Dose A

Treatment:

Drug: LC28-0126 Dose A

LC28-0126 Dose B

Experimental group

Description:

LC28-0126 Dose B

Treatment:

Drug: LC28-0126 Dose B

LC28-0126 Dose C

Experimental group

Description:

LC28-0126 Dose C

Treatment:

Drug: LC28-0126 Dose C

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo