Status:
COMPLETED
PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
Lead Sponsor:
Anthera Pharmaceuticals
Conditions:
Coronary Artery Disease (CAD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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). Subjec...
Detailed Description
A-002 represents a novel therapy for the treatment of atherosclerosis and coronary artery disease (CAD). Through the inhibition of activity A-002 may provide multifunctional activity directed against ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00455546
Start Date
April 1 2007
End Date
September 1 2007
Last Update
February 2 2010
Active Locations (36)
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1
Mobile Heart Specialists
Mobile, Alabama, United States, 36608
2
Sonoran Health Specialists
Scottsdale, Arizona, United States, 85260
3
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913
4
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316