CLINICAL TRIALS PROFILE FOR VARESPLADIB

Clinical Trials for Varespladib

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00434473 ↗	IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome	Completed	Anthera Pharmaceuticals	Phase 2	The study will be conducted at 15-20 US centers in a randomized, placebo-controlled, double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients at-risk for acute chest syndrome (ACS) based on the presence of vaso-occlusive crisis (VOC), fever (T ≥38.0°C) and serum sPLA2 concentration ≥50 ng/mL.
NCT00533039 ↗	sPLA2 Inhibition to Decrease Enzyme Release After PCI Trial	Completed	Anthera Pharmaceuticals	Phase 2	As evidence accumulates that atherogenesis or Coronary Artery Disease (CAD) may not be simply a disorder of lipid metabolism, but an inflammatory disease, the focus of treatment has shifted. A-002 or Varespladib is an anti-inflammatory drug for treatment of chronic and acute diseases. It acts by inhibiting secretory phospholipase A2 (sPLA2 ) - one of a family of enzymes leading to inflammation - which may be important in: 1) the development of atherosclerosis and 2) the increase in occurence of cardiovascular events after angioplasty. Previous studies have demonstrated that sPLA2: 1) facilitates the pro-atherogenic effects of low-density (LDL or bad cholesterol) and 2) increased levels post-angioplasty correlate with an increased risk of events at followup contact. Therefore this study proposes to investigate the ability of A-002 to prevent or reduce myocardial damage after angioplasty by inhibiting the cascade of inflammatory mediators. Substudy - Subjects who agree will also have a vascular ultrasound 24h post-PCI to assess endothelial function.
NCT00533039 ↗	sPLA2 Inhibition to Decrease Enzyme Release After PCI Trial	Completed	University Health Network, Toronto	Phase 2	As evidence accumulates that atherogenesis or Coronary Artery Disease (CAD) may not be simply a disorder of lipid metabolism, but an inflammatory disease, the focus of treatment has shifted. A-002 or Varespladib is an anti-inflammatory drug for treatment of chronic and acute diseases. It acts by inhibiting secretory phospholipase A2 (sPLA2 ) - one of a family of enzymes leading to inflammation - which may be important in: 1) the development of atherosclerosis and 2) the increase in occurence of cardiovascular events after angioplasty. Previous studies have demonstrated that sPLA2: 1) facilitates the pro-atherogenic effects of low-density (LDL or bad cholesterol) and 2) increased levels post-angioplasty correlate with an increased risk of events at followup contact. Therefore this study proposes to investigate the ability of A-002 to prevent or reduce myocardial damage after angioplasty by inhibiting the cascade of inflammatory mediators. Substudy - Subjects who agree will also have a vascular ultrasound 24h post-PCI to assess endothelial function.

Clinical Trial Conditions for Varespladib

Condition Name

Condition Name
Intervention	Trials
Acute Coronary Syndrome	2
Sickle Cell Disease	2
Vaso-occlusive Crisis	2

Condition MeSH

Condition MeSH
Intervention	Trials
Syndrome	4
Snake Bites	2
Anemia, Sickle Cell	2

Clinical Trial Locations for Varespladib

Trials by Country

Trials by Country
Location	Trials
United States	51
India	9
Hungary	9
Spain	8
Australia	8

Trials by US State

Trials by US State
Location	Trials
Georgia	3
Florida	3
California	3
North Carolina	3
District of Columbia	2

Clinical Trial Progress for Varespladib

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	8
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	4
Terminated	3
Recruiting	2

Clinical Trial Sponsors for Varespladib

Sponsor Name

Sponsor Name
Sponsor	Trials
Anthera Pharmaceuticals	7
Ophirex, Inc.	3
Premier Research International LLC	2

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	10
Other	5