PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will be conducted at up to 80 centers worldwide and will be a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease (CAD). Subjects will be randomized to receive either placebo tablets or one of 4 orally active doses of A-002. The duration of study drug therapy will be 8 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthera Pharmaceuticals
• Treatments: Varespladib methyl

Criteria

Inclusion Criteria:

Subjects are eligible for inclusion if they meet the following inclusion criteria:

• Men and women > 18 years of age

• Written informed consent from the subject

• Stable CAD

• Stable medical condition, will be compliant and able to comply with the requirements of the protocol

Exclusion Criteria:

• Subjects must NOT meet any of the following exclusion criteria:

• Planned CABG

• Hospitalization for acute coronary syndrome if troponin level is >0.1 ng/mL in the preceding 6 weeks

• Hospitalization for ST-segment acute myocardial infarction (STEMI) in the preceding 12 weeks

• Subjects with chronic inflammatory disease (e.g., RA), inflammatory bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring clinical intervention), or major surgery

• hs-CRP >15 mg/L repeated on at least 2 occasions >24 hours apart due to non-cardiovascular systemic inflammatory conditions (e.g., rheumatoid disease)

• Acute or chronic heart failure as defined by the NYHA classification as functional Class III or Class IV