PLASMA 2 Trial: Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by:
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00525954
First received: September 4, 2007
Last updated: January 3, 2008
Last verified: January 2008
  Purpose

The study will be conducted at up to 25 U.S. centers 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 2 orally active doses of A-002. The duration of study drug therapy will be 8 weeks.


Condition Intervention Phase
Coronary Artery Disease
Drug: A-002
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phospholipase Levels And Serological Markers of Atherosclerosis 2: An Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • The primary objective of this study is to determine the effect of once daily (QD) dosing of A-002 on sPLA2 levels and activity

Secondary Outcome Measures:
  • Determine the effect of QD dosing of A-002 on sPLA2 levels and activity at each time point (Weeks 2, 4, and 8)
  • Compare the effect of QD dosing of A-002 on sPLA2 enzyme levels and markers of inflammation
  • Determine plasma drug concentrations with QD dosing

Estimated Enrollment: 120
Study Start Date: September 2007
Estimated Study Completion Date: December 2007
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 key facets of the disease process, namely a) inflammation, b) atherogenic lipid profiles and c) the atherosclerotic process. Non-clinical and clinical data from recent studies have demonstrated the benefit of early and aggressive anti-inflammatory therapy to reduce cardiovascular risk. Recent clinical studies have provided a strong association between levels and cardiovascular event risk. The proposed Phase 2 clinical pharmacology study (Study No. AN-CVD-2222) will examine the effects of 2 different doses of A-002 compared with placebo, on enzyme levels and activity after 8 weeks of treatment. In addition, the effect of treatment on inflammatory markers of cardiovascular risk (C-reactive protein [CRP]), lipid levels and lipoprotein subclasses and other soluble biomarkers (e.g., ICAM-1, VCAM-1, TNF, MCP-1 etc) will also be assessed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. Men and women ≥18 years of age
  2. Written informed consent from the subject
  3. Stable CAD
  4. 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:

  1. Planned coronary artery bypass surgery (CABG)
  2. Acute or chronic heart failure as defined by the New York Heart Association (NYHA) classification as functional Class III or Class IV
  3. Hospitalization for acute coronary syndrome (ACS) if troponin >0.1 ng/mL in the preceding 6 weeks
  4. Hospitalization for ST-segment elevation acute myocardial infarction (STEMI) in the preceding 12 weeks
  5. Subjects with chronic inflammatory disease (e.g., rheumatoid arthritis), inflammatory bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring clinical intervention), or major surgery
  6. 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)
  7. Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening or prior experience with A-002.
  8. Subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision (e.g., chemotherapy), or radiation therapy
  9. Subjects who have received immunosuppressant therapy within 30 days prior to entry
  10. Subjects who have received anti-tumor necrosis factor (for example, infliximab) therapy within 6 months prior to entry
  11. The presence of severe liver disease with cirrhosis, recent active hepatitis, active chronic hepatitis, ALT or AST >3 x upper limit of normal, biliary obstruction with hyperbilirubinemia (total bilirubin >2 x upper limit of normal)
  12. Active cholecystitis, gall bladder symptoms, or potential hepato-biliary abnormalities
  13. The presence of moderate or severe renal impairment (CrCl <60 mL/min or creatinine >1.5 x upper limit of normal), nephrotic syndrome, or subjects undergoing dialysis
  14. Uncontrolled diabetes mellitus (known HbA1c >11% within the last 1 month prior to screening)
  15. Females who are nursing, pregnant, or intend to become pregnant during the time of the study, or subjects who have a positive serum pregnancy test at Visit 1 (if the subject is a female of child-bearing potential). Women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. A reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (IUD), contraceptive implants, tubal ligation, hysterectomy, a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom).
  16. Subjects who have a history of alcohol or drug abuse within 1 year of study entry
  17. Subject living too far from participating center or unable to return for follow-up visits
  18. Subjects who in the opinion of the Investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions
  19. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C Virus (HCV) infection
  20. Treatment with any systemic corticosteroid within the 30-day period prior to study entry or the use of inhaled steroids within the 14-day period prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525954

Locations
United States, Alabama
Mobile Heart Specialists
Mobile, Alabama, United States, 36608
United States, Arizona
Sonoran Health Specialists
Scottsdale, Arizona, United States, 85260
United States, Florida
Pasco Cardiology Center
Hudson, Florida, United States, 34667
Charlotte Cardiovascular Institute
Port Charlotte, Florida, United States, 33952
Florida Cardiovascular Research Institute
Tampa, Florida, United States, 33609
United States, Georgia
Augusta Cardiology Clinic
Augusta, Georgia, United States, 30901
United States, Kentucky
Louisville Cardiology Medical Group
Louisville, Kentucky, United States, 40207
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
United States, New York
United Medical Associates
Binghamton, New York, United States, 13901
Cardiology PC
Syracuse, New York, United States, 13210
United States, Texas
Austin Heart
Austin, Texas, United States, 78705
United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Wisconsin Heart, SC
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

No publications provided by Anthera Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00525954     History of Changes
Other Study ID Numbers: AN-CVD2222
Study First Received: September 4, 2007
Last Updated: January 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:
Coronary
Artery
Artheroschlerosis
Phospholipase
CAD
Coronary Artery Disease (CAD)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014