VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01130246
First received: April 19, 2010
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

The objective of this study is to evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS).


Condition Intervention Phase
Acute Coronary Syndrome
Drug: A-002, varespladib methyl
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: VISTA-16 Trial: Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes

Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • Primary Objective of the Study [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    To determine whether 16 weeks of treatment with A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the hazard of the first occurrence of the combined endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.


Secondary Outcome Measures:
  • Secondary Objective of the Study [ Time Frame: 2, 4, 8, 16 weeks and 6 months ] [ Designated as safety issue: No ]
    To determine whether A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the occurrence of the hazard of the combined endpoint of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or documented unstable angina with objective evidence of ischemia requiring hospitalization or multiple occurrences of the non-fatal components of the composite primary endpoint.


Enrollment: 5189
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A-002 500 mg
Once daily oral administration
Drug: A-002, varespladib methyl
A-002 administered once daily in addition to atorvastatin and standard of care
Placebo Comparator: Matched Placebo
Once daily oral administration
Drug: Placebo
Placebo administered once daily in addition to atorvastatin and standard of care

Detailed Description:

A double-blind randomized parallel group placebo controlled study in subjects presenting with an ACS. Up to 6500 subjects will be randomized to receive either A-002 500 mg once daily (QD) or placebo tablets in addition to atorvastatin QD and standard of care. Treatment will be 16 weeks in duration. The dose of atorvastatin shall be adjusted after 8 weeks if subject's LDL-C is ≥100 mg/dL, but otherwise must remain stable throughout the16-week duration of study. The survival status for all enrolled subjects will be ascertained 6 months after they complete the study.

Randomization must occur within ≤96 hours of hospitalization for the index ACS event, or if already hospitalized, within ≤96 hours of index event diagnosis. Follow-up visits will occur on Weeks 1, 2, 4, 8, and 16. A 6 month follow-up visit will also occur.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women ≥40 years of age
  2. Written informed consent from the subject
  3. A diagnosis of unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI)

    Unstable angina is defined as:

    • Chest pain symptomatic of ischemia or angina occurring at rest or on minimal exertion with a pattern of increasing frequency or severity, lasting >10 minutes and consistent with myocardial ischemia within 24 hours prior to hospitalization and
    • New or dynamic ST-segment depression or prominent T-wave inversion changes in at least 2 contiguous leads and
    • In addition subjects meeting the above criteria for unstable angina must also have either troponin I, troponin T or CKMB above the LLD but below the 99th percentile of the upper reference limit (URL) and not due to cardioversion or underlying cardiovascular (CHF, cardiomyopathy) or renal disease

    NSTEMI is defined as:

    • Chest pain symptomatic of ischemia
    • No electrocardiogram (ECG) changes, or ST-depression, or T wave changes(i.e., no new Q waves on serial ECGs)and
    • Increase in cardiac troponin > local limit for the definition of myocardial infarction or increase in CK-MB isoenzyme > URL

    STEMI is defined as:

    • Chest pain symptomatic of ischemia
    • ST segment elevation and associated T wave changes or ST-segment elevation of at least 2 mm in 2 contiguous leads, either of which persisting for longer than 15 minutes and
    • Increase in cardiac troponin > local limit for the definition of myocardial infarction or increase in CK-MB >URL
  4. All subjects must have the presence of at least one of the following risk factors:

    • Diabetes Mellitus or
    • Presence of any 3 of the following characteristics of metabolic syndrome

      • Waist circumference >102 cm in males, >88 cm in females
      • Serum triglycerides ≥150 mg/dL (≥1.7 mmol/L)
      • HDL-C <40 mg/dL (<1 mmol/L) in males, <50 mg/dL (<1.3 mmol/L) in females
      • Blood pressure ≥130/85 mmHg
      • Plasma glucose ≥110 mg/dL (≥6.1 mmol/L) or
    • history of cerebrovascular disease (stroke or TIA) or
    • history of peripheral vascular disease or
    • previous CABG or
    • previous documented myocardial infarction or
    • previous coronary revascularization
  5. Subjects must be randomized within ≤96 hours of hospital admission for the index event, or if already hospitalized, within ≤96 hours of index event diagnosis
  6. Revascularization, if required or planned, must occur prior to randomization

Exclusion Criteria:

  1. Subjects enrolled in another experimental (interventional)protocol within the past 30 days prior to Screening.
  2. 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 or radiation therapy (e.g. chemotherapy)
  3. The presence of any severe liver disease with cirrhosis, active hepatitis, active chronic hepatitis, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN, biliary obstruction with hyperbilirubinemia (total bilirubin >2 x ULN)
  4. Active cholecystitis, gall bladder symptoms, or any hepatobiliary abnormalities
  5. The presence of severe renal impairment (creatinine clearance [CrCl] <30 mL/min or creatinine >3 x ULN),nephrotic syndrome, or subjects undergoing dialysis
  6. Uncontrolled diabetes mellitus (known hemoglobin A1c [HbA1c] >11% within the last 1 month prior to Screening)
  7. Females who are nursing, pregnant, or intend to become pregnant during the time of the study, or females of childbearing potential who have a positive pregnancy test during screening evaluation. 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).
  8. Subjects who have a history of alcohol or drug abuse within 1 year of study entry
  9. Subjects living too far from participating center or unable to return for follow-up visits
  10. 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
  11. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection
  12. Acute bacterial, fungal or viral infection
  13. Subjects currently taking drugs that are potent inhibitors of cytochrome P450 unless they can be withdrawn
  14. Subjects with New York Heart Association (NYHA) Class III or IV heart failure, or if known, left ventricular ejection fraction (LVEF) <30
  15. Subjects with moderate or severe aortic stenosis, aortic regurgitation, mitral stenosis or mitral regurgitation
  16. Ventricular arrhythmias requiring chronic drug treatment or implantable cardioverter-defibrillator (ICD)
  17. Subjects with no stenosis or stenosis <50% on angiography, if known
  18. Subjects with a pacemaker or persistent left bundle branch block (LBBB)
  19. Fasting triglyceride levels of ≥400 mg/dL (4.5 mmol/L)
  20. Subjects who have a history of statin intolerance or a significant myopathy or rhabdomyolysis with any lipid altering drugs
  21. Subjects currently treated with the maximum labeled dose of a statin and not at LDL-C target for their level of risk as defined by NCEP ATP III
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130246

  Hide Study Locations
Locations
United States, Alabama
Investigator Site 1063
Birmingham, Alabama, United States, 35235
Investigator Site 1064
Birmingham, Alabama, United States, 35205
Investigator Site 1065
Birmingham, Alabama, United States, 35243
Investigator Site 1020
Huntsville, Alabama, United States, 35801
Investigator Site 1133
Mobile, Alabama, United States, 36608
United States, Arizona
Investigator Site 1019
Tucson, Arizona, United States, 85724
United States, California
Investigator Site 1132
Escondido, California, United States, 92025
Investigator Site 1087
Mission Viejo, California, United States, 92691
Investigator Site 1005
Torrance, California, United States, 90502
United States, Colorado
Investigator Site 1079
Aurora, Colorado, United States, 80012
Investigator Site 1006
Colorado Springs, Colorado, United States, 80909
Investigator Site 1045
Denver, Colorado, United States, 80220
Investigator Site 1050
Denver, Colorado, United States, 80218
Investigator Site 1061
Fort Collins, Colorado, United States, 80528
Investigator Site 1054
Littleton, Colorado, United States, 80120
Investigator Site 1140
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Investigator Site 1111
Hartford, Connecticut, United States, 06102
United States, Delaware
Investigator Site 1028
Newark, Delaware, United States, 19718
United States, District of Columbia
Investigator Site 1030
Washington, District of Columbia, United States, 20037
Inevestigator Site 1074
Washington, District of Columbia, United States, 20010
Investigator Site 1117
Washington, District of Columbia, United States, 20422
United States, Florida
Investigator Site 1051
Clearwater, Florida, United States, 33756
Investigator Site 1022
Clearwater, Florida, United States, 33756
Investigator Site 1112
Ft. Lauderdale, Florida, United States, 33316
Investigator Site 1049
Lakeland, Florida, United States, 33805
Investigator Site 1124
Miami Beach, Florida, United States, 33140
Investigator Site 1095
Tallahassee, Florida, United States, 32308
Investigator Site 1058
Tampa, Florida, United States, 33613
United States, Georgia
Investigator Site1110
Atlanta, Georgia, United States, 30342
Investigator Site 1011
Augusta, Georgia, United States, 30901
Investigator Site 1114
Macon, Georgia, United States, 31201
United States, Illinois
Investigator Site 1086
Naperville, Illinois, United States, 60540
Investigator Site 1125
Oak Lawn, Illinois, United States, 60453
United States, Louisiana
Investigator Site 1044
Covington, Louisiana, United States, 70433
Investigator Site 1069
New Orleans, Louisiana, United States, 70112
Investigator Site 1066
New Orleans, Louisiana, United States, 70115
Investigator Site 1144
Shreveport, Louisiana, United States, 71101
United States, Michigan
Investigator Site 1060
Flint, Michigan, United States, 48532
Investigator Site 1136
Novi, Michigan, United States, 48374
Investigator Site 1137
Petoskey, Michigan, United States, 49770
Investigator Site 1048
Traverse City, Michigan, United States, 49684
United States, Minnesota
Investigator Site 1034
Duluth, Minnesota, United States, 55807
Investigator Site 1046
Minneapolis, Minnesota, United States, 55407
Investigator Site 1033
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
Investigator Site 1016
Tupelo, Mississippi, United States, 38801
United States, Montana
Investigator Site 1027
Kalispell, Montana, United States, 59901
Investigator Site 1092
Missoula, Montana, United States, 59802
United States, Nebraska
Investigator Site 1032
Omaha, Nebraska, United States, 68131
United States, New Jersey
Investigator Site 1031
Ridgewood, New Jersey, United States, 07450
United States, New York
Investigator Site 1057
Johnson City, New York, United States, 13790
United States, North Carolina
Investigator Site 1101
Charlotte, North Carolina, United States, 28204
Investigator Site 1100
Gastonia, North Carolina, United States, 28054
Investigator Site 1088
Raleigh, North Carolina, United States, 27610
Investigator Site 1121
Raleigh, North Carolina, United States, 27609
Investigator Site 1123
Wilmington, North Carolina, United States, 28401
Investigator Site 1075
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Investigator Site 1108
Fargo, North Dakota, United States, 58122
United States, Ohio
Investigator Site 1024
Canton, Ohio, United States, 44710
Investigator Site 1143
Cleveland, Ohio, United States, 44106
Investigator 1141
Cleveland, Ohio, United States, 44109
Investigator Site 1131
Mansfield, Ohio, United States, 44901
United States, Oklahoma
Investigator Site 1026
Oklahoma City, Oklahoma, United States, 73112
Investigator Site 1004
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Investigator Site 1122
Portland, Oregon, United States, 97239
United States, Pennsylvania
Investigator Site 1107
Danville, Pennsylvania, United States, 17822
Investigator Site 1029
Doylestown, Pennsylvania, United States, 18901
Investigator Site 1134
Lancaster, Pennsylvania, United States, 17602
Investigator Site 1018
York, Pennsylvania, United States, 17405
United States, Rhode Island
Investigator Site 1072
Providence, Rhode Island, United States, 02906
United States, South Dakota
Investigator Site 1038
Rapid City, South Dakota, United States, 55701
Investigator Site 1138
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Investigator Site 1014
Jackson, Tennessee, United States, 38305
Investigator Site 1047
Knoxville, Tennessee, United States, 37917
United States, Texas
Investigator Site 1040
Dallas, Texas, United States, 75226
Investigator Site 1115
Dallas, Texas, United States, 75216
Investigator Site 1037
Houston, Texas, United States, 77030
Investigator Site 1130
Houston, Texas, United States, 77030
Investigator Site 1025
Tyler, Texas, United States, 75501
United States, Utah
Investigator Site 1139
Layton, Utah, United States, 84041
United States, Virginia
Investigator Site 1056
Harrisonburg, Virginia, United States, 22801
Investigator Site 1083
Norfolk, Virginia, United States, 23507
Investigator Site 1043
Richmond, Virginia, United States, 23249
United States, Wisconsin
Investigator Site 1042
Marshfield, Wisconsin, United States, 54449
Australia, Australian Capital Territory
Investigator Site 6106
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
Investigator Site 6114
Gosford, New South Wales, Australia, 2250
Investigator Site 6120
Kingswood, New South Wales, Australia, 2747
Australia, Queensland
Investigator Site 6113
Cairns, Queensland, Australia, 4870
Investigator Site 6112
Douglas, Queensland, Australia, 4814
Investigator Site 6123
Nambour, Queensland, Australia, 4560
Australia, South Australia
Investigator Site 6111
Adelaide, South Australia, Australia, 5000
Investigator Site 6124
Bedford Park, South Australia, Australia, 5042
Investigator Site 6103
Elizabeth Vale, South Australia, Australia, 5112
Australia, Tasmania
Investigator Site 6122
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Investigator Site 6129
Epping, Victoria, Australia, 3076
Investigator Site 6127
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Investigator Site 6125
Perth, Western Australia, Australia, 6000
Investigator Site 6130
Perth, Western Australia, Australia, 6000
Australia
Investigator Site 6118
Brisbane, Australia
Investigator Site 6126
Geelong, Australia
Investigator Site 6101
Kogarah, Australia, NSW2217
Investigator Site 6105
Melbourne, Australia, 3004
Investigator Site 6110
Nedlands, Australia, 6009
Investigator Site 6121
New Lambton, Australia, NSW2305
Investigator Site 6108
So Australia, Australia
Investigator Site 6119
South Port, Australia, 4215QLD
Canada, Alberta
Investigator Site 2069
Calgary, Alberta, Canada, T2N 2T9
Investigator Site 2065
Edmonton, Alberta, Canada, T6G 2B7
Investigator Site 2064
Edmonton, Alberta, Canada, T6L 5X8
Investigator Site 2073
Red Deer, Alberta, Canada, T4N 4E7
Canada, British Columbia
Investigator Site 2059
Kelowna, British Columbia, Canada, V1Y 1E4
Investigator Site 2068
New Westminister, British Columbia, Canada, v3L3W4
Investigator Site 2066
Surrey, British Columbia, Canada, V3V 1Z2
Investigator Site 2057
Vancouver, British Columbia, Canada, V6Z1Y6
Investigator Site 2063
Victoria, British Columbia, Canada, V8R4R2
Canada, Newfoundland and Labrador
Investigator Site 2070
Saint John, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Investigator Site 2048
Halifax, Nova Scotia, Canada, B3H 3A7
Investigator Site 2072
Sydney, Nova Scotia, Canada, B1P1P3
Canada, Ontario
Investigator Site 2067
Hamilton, Ontario, Canada, L8L2X2
Investigator Site 2075
Kitchener, Ontario, Canada, N2M 1B2
Investigator Site 2058
London, Ontario, Canada, N6A 5A5
Investigator Site 2004
Newmarket, Ontario, Canada, L3Y 8C3
Investigator Site 2008
Scarborough, Ontario, Canada, M1E4B9
Investigator Site 2030
Thunder Bay, Ontario, Canada, P7B7C7
Investigator Site 2011
Toronto, Ontario, Canada, J6V2H2
Investigator Site 2012
Toronto, Ontario, Canada, M5B1W8
Canada, Quebec
Investigator Site 2074
Laval, Quebec, Canada, H7M 3L9
Investigator Site 2020
Lévis, Quebec, Canada, G6V 4Z5
Investigator Site 2052
Montreal, Quebec, Canada, H2W1T8
Investigator Site 2009
Montreal, Quebec, Canada, H1T 2M4
Investigator Site 2001
Montreal, Quebec, Canada, H3H2R9
Investigator Site 2071
St. Jerome, Quebec, Canada, J7Z5T3
Investigator Site 2006
Terrebonne, Quebec, Canada, J6V2H2
Canada
Investigator Site 2007
Quebec, Canada, G1V4G5
Investigator Site 2053
Quebec, Canada, G1R 2J6
Investigator Site 2010
Saint John, Canada, NBE2L4L2
Czech Republic
Investigator Site 4212
Jihlavska, Brno, Czech Republic, 62500
Investigator Site 4201
Usti nad Labem, Labem, Czech Republic, 40113
Investigator Site 4216
Liberec, Stare Mesto, Czech Republic, 46063
Investigator Site 4210
Brno, Czech Republic, 656 91
Investigator Site 4206
Hradec Kralove, Czech Republic, 500 05
Investigator Site 4208
Jihlava, Czech Republic, 58633
Investigator Site 4214
Mlada Boleslav, Czech Republic, 29350
Investigator 4218
Nymburk, Czech Republic, 425/9
Investigator Site 4218
Nymburk, Czech Republic, 288 02
Investigator Site 4207
Olomouc, Czech Republic, 755 20
Investigator Site 4209
Ostrava, Czech Republic, 70852
Investigator Site 4205
Plzen, Czech Republic, 30599
Investigator Site 4220
Praha, Czech Republic, 6
Investigator Site 4213
Praha, Czech Republic, 10034
Investigator Site 4204
Praha 2, Czech Republic, 12802
Investigator Site 4217
Praha 5, Czech Republic, 150 06
Investigator Site 4202
Usti nad Labem, Czech Republic, 401 13
Investigator Site 4203
Znojmo, Czech Republic, 66902
Georgia
Investigator Site 9501
Tbilisi, Georgia, 0159
Investigator Site 9506
Tbilisi, Georgia, 0164
Investigator Site 9502
Tbilisi, Georgia, 0102
Investigator Site 9503
Tbilisi, Georgia, 0179
Investigator Site 9505
Tbilisi, Georgia, 0159
Investigator Site 9504
Tbilisi, Georgia, 0141
Investigator Site 9509
Tbilisi, Georgia, 0144
Investigator Site 9508
Tbilisi, Georgia, 0102
Investigator Site 9507
Tbilisi, Georgia, 0186
Investigator Site 9510
Tbilisi, Georgia, 0144
Germany
Investigator Site 4921
Warendorf, Am Krankenhaus, Germany, 48231
Investigator Site 4932
Bad Friedrichshall, Germany, 74177
Investigator Site 4930
Bad Nauheim, Germany, 61231
Investigator Site 4928
Berlin, Germany, 12559
Investigator Site 4904
Bielefeld, Germany, 336 04
Investigator Site 4905
Bonn, Germany, 53105
Investigator Site 4923
Dortmund, Germany, 44137
Investigator Site 4912
Erfurt, Germany, 99089
Investigator Site 4907
Goettingen, Germany, 37075
Investigator Site 4922
Hamburg, Germany, 21075
Investigator Site 4929
Kassel, Germany, 34121
Investigator Site 4911
Kiel, Germany, 24105
Investigator Site 4901
Limburg, Germany, 65549
Investigator Site 4927
Lubeck, Germany, 23538
Investigator Site 4908
Magdeburg, Germany, 39120
Investigator Site 4902
Mainz, Germany, 55131
Investigator Site 4917
Munchen, Germany
Investigator Site 4925
Nauen, Germany, 14641
Investigator Site 4915
Regensburg, Germany, 93053
Investigator Site 4906
Ulm, Germany, 89081
Hungary
Investigator Site 3626
Pecs, Baranya Megye, Hungary, H-7624
Investigator Site 3606
Szekesfehervar, Fejer Megye, Hungary, 8000
Investigator Site 3602
Budapest, Gaal Jozsef, Hungary
Investigator Site 3605
Debrecen, Hajdu-Bihar, Hungary, 4012
Investigator Site 3614
Semmelweis, Kistarcsa, Hungary, 2143
Investigator Site 3612
Budapest, Pest Megye, Hungary, 1097
Investigator Site 3616
Budapest, Pest Megye, Hungary, 1076
Investigator Site 3607
Szolnok, Szolnok Megye, Hungary, 5000
Investigator Site 3603
Zalaegerszeg, Zala Megye, Hungary, H-8900
Investigator Site 3625
Balatonfured, Hungary, 8203
Investigator Site 3622
Budapest, Hungary, 1106
Investigator Site 3604
Budapest, Hungary, 1096
Investigator Site 3619
Eger, Hungary, 3300
Investigator Site 3624
Hodmezovasarhely, Hungary, 6800
Investigator Site 3629
Sopron, Hungary, 9400
Investigator Site 3623
Szombathely, Hungary, 9700
India
Investigator Site 9110
Hyderabad, Andhra Pradesh, India, 500082
Investigator Site 9109
Secunderabad, Andhra Pradesh, India, 500003
Investigator Site 9119
Secunderabad, Andhra Pradesh, India, 500003
Investigator Site 9105
New Delhi, Delhi, India, 110076
Investigator Site 9104
Ahmedabad, Gujarat, India, 380 014
Investigator Site 9108
Ahmedabad, Gujarat, India, 380060
Investigator Site 9111
Ahmedabad, Gujarat, India, 380052
Investigator Site 9117
Surat, Gujarat, India, 395007
Investigator Site 9102
Vadodara, Gujarat, India, 390007
Investigator Site 9115
Vadodara, Gujarat, India, 390 015
Investigator Site 9114
Bangalore, Karanataka, India, 560 0034
Investigator Site 9121
Bangalore, Karnataka, India, 560 052
Investigator Site 9113
Indore, Madhya Pradesh, India, 452008
Investigator Site 9101
Nagpur, Maharashtra, India, 440012
Investigator Site 9103
Lucknow, Uttar Pradesh, India, 226003
Investigator Site 9107
Kolkata, West Bengal, India, 700027
Investigator Site 9118
Kolkata, West Bengal, India, 7000020
Italy
Investigator Site 3921
Brescia, Via L Bissolati, Italy, 57
Investigator Site 3908
Cecina, Italy, 57023
Investigator Site 3912
Colleferro, Italy, 00034
Investigator Site 3910
Ferrara, Italy, 44121
Investigator Site 3916
Massa, Italy, 54100
Investigator Site 3906
Milano, Italy, 20138
Investigator Site 3901
Monza, Italy, 20052
Investigator Site 3907
Napoli, Italy, 80131
Investigator Site 3920
Novara, Italy, 28100
Investigator Site 3918
Roma, Italy, 00135
Investigator Site 3909
Rome, Italy, 00189
Investigator Site 3902
Rome, Italy, 00168
Investigator Site 3903
Rozzano (MI), Italy, 20089
Investigator Site 3904
Siena, Italy, 53100
Korea, Republic of
Investigator Site 8205
Busan, Korea, Republic of, 602-715
Investigator Site 8206
Busan, Korea, Republic of, 602-739
Investigator Site 8202
Cheongju, Korea, Republic of, 361-711
Investigator Site 8214
Daegu, Korea, Republic of, 700-712
Investigator Site 8213
Daejeon, Korea, Republic of, 301-723
Investigator Site 8203
Gwangju, Korea, Republic of, 501-757
Investigator Site 8204
Gyeonggi-do, Korea, Republic of, 480-717
Investigator Site 8210
Kangwon-do, Korea, Republic of, 220-701
Investigator Site 8201
Seoul, Korea, Republic of, 152-703
Investigator Site 8207
Seoul, Korea, Republic of, 135-720
Investigator Site 8209
Seoul, Korea, Republic of, 130-702
Investigator Site 8212
Seoul, Korea, Republic of, 135-710
Investigator Site 8215
Seoul, Korea, Republic of, 130-709
Investigator Site 8208
Suwon, Korea, Republic of, 442-723
Investigator Site 8211
Suwon, Korea, Republic of, 443-721
Lebanon
Investigator Site 9603
Bir Hassan, Jnah, Lebanon
Investigator Site 9601
Beirut, Lebanon, BEI
Investigator Site 9603
Beirut, Lebanon
Netherlands
Investigator Site 3126
Nieuwegein, CM, Netherlands, 3435
Investigator Site 3129
Goes, RA, Netherlands, 4462
Investigator Site 3120
Amstelveen, Netherlands, 1186 AM
Investigator Site 3125
Amsterdam, Netherlands
Investigator Site 3128
Amsterdam, Netherlands, 1081 HV
Investigator Site 3117
Amsterdam, Netherlands, 1091 AC
Investigator Site 3136
Breda, Netherlands, 4818
Investigator Site 3130
Delft, Netherlands, 2625 AD
Investigator Site 3108
Den Helder, Netherlands, 1782 GZ
Investigator Site 3105
Deventer, Netherlands, 7416 SE
Investigator Site 3102
Ede, Netherlands, 6716RP
Investigator Site 3134
Heerlen, Netherlands, 6419 PC
Investigator Site 3109
Hoogeveen, Netherlands, 7909 AA
Investigator Site 3101
Leeuwarden, Netherlands
Investigator Site 3118
Leiden, Netherlands, 2333 ZA
Investigator Site 3112
Purmerend, Netherlands, 1447 TC
Investigator Site 3107
Roosendaal, Netherlands, 4708 AE
Investigator Site 3123
Rotterdam, Netherlands, 3075 EA
Investigator Site 3106
Rotterdam, Netherlands, 3045 PM
Investigator Site 3104
Rotterdam, Netherlands, 3011 TD
Investigator Site 3131
Schiedam, Netherlands, 3118 JH
Investigator Site 3135
Sneek, Netherlands, 8601 ZK
Investigator Site 3103
Tilburg, Netherlands, 5022 CG
Investigator Site 3116
Utrecht, Netherlands, 3584 CX
Investigator Site 3124
Venlo, Netherlands, 5912 BL
Investigator Site 3113
Zaandam, Netherlands, 1502 DV
New Zealand
Investigator Site 6402
Takapuna, Auckland, New Zealand, 0622
Investigator Site 6405
Christchurch, New Zealand, 8011
Investigator Site 6404
Dunedin, New Zealand, 9054
Investigator Site 6401
Hamilton, New Zealand, 3240
Investigator Site 6406
Wellington, New Zealand, 6021
Poland
Investigator Site 4825
Wroc³aw, Dolnoslaskie, Poland, 53-114
Investigator Site 4804
Inowroclaw, Kujawsko-pomorskie, Poland, 88-100
Investigator Site4819
Pulawy, Podkarpackie, Poland, 24-100
Investigator Site 4828
Gdansk, Pomorskie, Poland, 80-952
Investigator Site 4809
Bialystok, Poland, 15-276
Investigator Site 4813
Bialystok, Poland, 15-276
Investigator Site 4801
Bytom, Poland, 41-902
Investigator Site 4816
Stalowa Wola, Poland, 37-450
Investigator Site 4827
Szczecin, Poland, 70-111
Investigator Site 4823
Warszawa, Poland, 04-628
Investigator Site 4806
Warszawa, Poland, 02-507
Investigator Site 4812
Warszawa, Poland, 00-685
Investigator Site 4815
Warszawa, Poland, 01-809
Investigator Site 4824
Wroclaw, Poland, 50-367
Russian Federation
Investigator Site 7026
Barnaui, Russian Federation, 656099
Investigator Site 7021
Chelyabinsk, Russian Federation
Investigator Site 7001
Ekaterinburg, Russian Federation, 620109
Investigator Site 7023
Irkutsk, Russian Federation, 664079
Investigator Site 7020
Kazan, Russian Federation, 420101
Investigator Site 7002
Kemerovo, Russian Federation, 650002
Investigator Site 7017
Krasnoyarsk, Russian Federation
Investigator Site 7024
Kursk, Russian Federation, 305035
Investigator Site 7007
Leningrad, Russian Federation
Investigator Site 7003
Moscow, Russian Federation, 111539
Investigator Site 7015
Moscow, Russian Federation, 119620
Investigator Site 7019
Moscow, Russian Federation, 121552
Investigator Site 7018
Murmansk, Russian Federation, 183047
Investigator Site 7004
Novosibirsk, Russian Federation, 630008
Investigator Site 7027
Novosibirsk, Russian Federation
Investigator Site 7022
Orenburg, Russian Federation, 460040
Investigator Site 7016
Rostov-on-Don, Russian Federation, 344068
Investigator Site 7005
Samara, Russian Federation, 443070
Investigator Site 7006
Saratov, Russian Federation, 410054
Investigator Site 7028
Saratov, Russian Federation
Investigator Site 7008
St. Petersburg, Russian Federation, 198205
Investigator Site 7010
St. Petersburg, Russian Federation
Investigator Site 7013
St. Petersburg, Russian Federation
Investigator Site 7025
St. Petersburg, Russian Federation
Investigator Site 7009
St.Petersburg, Russian Federation, 191015
Investigator Site 7011
Tomsk, Russian Federation, 634012
Investigator Site 7012
Tyumen, Russian Federation, 625026
Spain
Investigator Site 3404
Oviedo, Asturias, Spain, 33006
Investigator Site 3432
Badalona, Barcelona, Spain, 08916
Investigator Site 3420
Coslada, Madrid, Spain, 28820
Investigator Site 3419
Fuenlabrada, Madrid, Spain, 28942
Investigator Site 3413
Majadahonda, Madrid, Spain, 28222
Investigator Site 3411
Lorca, Murcia, Spain, 30800
Investigator Site 3416
Pamplona, Navarra, Spain, 31008
Investigator Site 3408
Vigo, Pontevedra, Spain, 36211
Investigator Site 3410
Vigo, Pontevedra, Spain, 36214
Investigator Site 3425
Galdakao, Vizcaya, Spain, 48960
Investigator Site 3435
Albacete, Spain, 02006
Investigator Site 3418
Barcelona, Spain, 08906
Investigator Site 3428
Barcelona, Spain, 08025
Investigator Site 3406
Girona, Spain, 17007
Investigator Site 3407
Huelva, Spain, 21005
Investigator Site 3430
Leganes, Spain, 28911
Investigator Site 3402
Lleida, Spain, 25198
Investigator Site 3409
Madrid, Spain, 28007
Investigator Site 3401
Madrid, Spain, 28046
Investigator Site 3423
Madrid, Spain, 28040
Investigator Site 3415
Malaga, Spain, 29010
Investigator Site 3421
Malaga, Spain, 29010
Investigator Site 3431
Pontevedra, Spain, 36071
Investigator Site 3424
Reus, Spain, 43206
Investigator Site 3414
Santa Cruz de Tenerife, Spain, 38010
Investigator Site 3434
Sevilla, Spain, 41009
Investigator Site 3422
Utrera, Spain, 41710
Investigator Site 3403
Valencia, Spain, 46014
Ukraine
Investigator Site 3809
Dnipropetrovsk, Ukraine, 49006
Investigator Site 3807
Ivano-Frankivsk, Ukraine, 76014
Investigator Site 3802
Kharkiv, Ukraine, 61018
Investigator Site 3806
Kharkiv, Ukraine, 61002
Investigator Site 3810
Kharkiv, Ukraine
Investigator Site
Kharkiv, Ukraine, 61039
Investigator Site 3803
Kharkiv, Ukraine, 61039
Investigator Site 3801
Kiev, Ukraine, 02175
Investigator Site 3805
Kiev, Ukraine
Investigator Site 3808
Kiev, Ukraine
Investigator Site 3811
Lviv, Ukraine
Investigator Site 3815
Odessa, Ukraine
Investigator Site 3813
Odessa, Ukraine, 65014
Investigator Site 3814
Poltava, Ukraine, 36039
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):
Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01130246     History of Changes
Other Study ID Numbers: AN-CVD2233
Study First Received: April 19, 2010
Last Updated: October 30, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
Georgia: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Ukraine: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
India: Drugs Controller General of India
Czech Republic: Ethics Committee
Hungary: Research Ethics Medical Committee

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Varespladib methyl
Phospholipase A2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014