Phase 2 Study to Evaluate the Efficacy, Safety and PK of... | NCT02070471

Official Title

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)

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LC28-0126 Dose A	Experimental	LC28-0126 Dose A	Drug: LC28-0126 Dose A
LC28-0126 Dose B	Experimental	LC28-0126 Dose B	Drug: LC28-0126 Dose B
LC28-0126 Dose C	Experimental	LC28-0126 Dose C	Drug: LC28-0126 Dose C
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo	Placebo
LC28-0126 Dose A

Outcomes Module

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

Secondary Outcomes

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

Eligibility Module

Contacts/Locations Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis