The Evaluation Of PF-04950615 (RN316) In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects (SPIRE-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01975389
First received: October 21, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

This study evaluates the PCSK9 inhibitor, PF-04950615 (RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).


Condition Intervention Phase
Cardiovascular Disease
Drug: PF-04950615
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of PF 04950615, In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Cardiovascular event [ Time Frame: The time from Randomization to the first adjudicated and confirmed occurrence of a primary endpoint major cardiovascular event, up to Month 60 ] [ Designated as safety issue: No ]
    Confirmed occurrence of a major cardiovascular event, a composite endpoint which includes CV death, non fatal MI, non fatal stroke, and hospitalization for unstable angina needing urgent revascularization


Secondary Outcome Measures:
  • Hospitalization for unstable angina needing urgent revascularization [ Time Frame: The time from randomization to the first adjudicated and confirmed hospitalization for unstable angina needing urgent revascularization, assessed up to Month 60 ] [ Designated as safety issue: No ]
  • A composite endpoint of CV death, non fatal MI, and non fatal stroke [ Time Frame: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of CV death, non-fatal MI, and non-fatal stroke, assessed up to Month 60 ] [ Designated as safety issue: No ]
  • A composite endpoint of all-cause death, non fatal MI, and non fatal stroke, and hospitalization for unstable angina needing urgent revascularization. [ Time Frame: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of all-cause death, non-fatal MI, and non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization, assessed up to M60 ] [ Designated as safety issue: No ]

Estimated Enrollment: 6300
Study Start Date: October 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04950615 Drug: PF-04950615
150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
Other Name: RN316
Placebo Comparator: Placebo Drug: Placebo
Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.

  Eligibility

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

Inclusion Criteria:

  • Must be on background lipid lowering treatment.
  • Must be at high risk of a CV event.
  • Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).

Exclusion Criteria:

  • An LDL C <100 mg/dL (2.6 mmol/L) or non HDL C <130 mg/dL (3.4 mmol/L).
  • Planned coronary (PCI or CABG) or other arterial revascularization.
  • New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
  • Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis.
  • History of hemorrhagic stroke.
  • Prior exposure to PF 04950615 (RN316) or other investigational PCSK9 inhibitor.
  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: NCT01975389

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
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Athens, Alabama, United States, 35611
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Birmingham, Alabama, United States, 35233
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Birmingham, Alabama, United States, 35294
United States, Arizona
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Glendale, Arizona, United States, 85308
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Tempe, Arizona, United States, 85282
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Tucson, Arizona, United States, 85710
United States, California
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El Cajon, California, United States, 92020
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Encinitas, California, United States, 92024
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Lincoln, California, United States, 95648
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Los Gatos, California, United States, 95032
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Mission Hills, California, United States, 91345
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Poway, California, United States, 92064
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Santa Monica, California, United States, 90404
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Stockton, California, United States, 95204
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Thousand Oaks, California, United States, 91360
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Torrance, California, United States, 90502
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Colorado Springs, Colorado, United States, 80907
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Denver, Colorado, United States, 80246
United States, Connecticut
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Stamford, Connecticut, United States, 6905
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Atlantis, Florida, United States, 33462
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Clearwater, Florida, United States, 33756
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Fort Lauderdale, Florida, United States, 33308
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Fort Lauderdale, Florida, United States, 33316
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Fort Lauderdale, Florida, United States, 33316
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Ft. Lauderale, Florida, United States, 33308
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Jacksonville, Florida, United States, 32207
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Jacksonville, Florida, United States, 32216
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Miami, Florida, United States, 33176
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Miami, Florida, United States, 33126
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Miami, Florida, United States, 33183
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Miami, Florida, United States, 33173
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Miami Springs, Florida, United States, 33166
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Oakland Park, Florida, United States, 33309
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Orlando, Florida, United States, 32860
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Tamarac, Florida, United States, 33319
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West Palm Beach, Florida, United States, 33401
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Atlanta, Georgia, United States, 30318
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Decatur, Georgia, United States, 30033
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Norcross, Georgia, United States, 30092
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Brownsburg, Indiana, United States, 46112
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Evansville, Indiana, United States, 47713
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Evansville, Indiana, United States, 47714
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Evansville, Indiana, United States, 47725
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Muncie, Indiana, United States, 47304
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Valparaiso, Indiana, United States, 46383
United States, Iowa
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Council Bluffs, Iowa, United States, 51501
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Iowa City, Iowa, United States, 52242
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Overland Park, Kansas, United States, 66209
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Lexington, Kentucky, United States, 40503
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Louisville, Kentucky, United States, 40213
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Ann Arbor, Michigan, United States, 48106
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Bingham Farms, Michigan, United States, 48025
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Troy, Michigan, United States, 48085
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Troy, Michigan, United States, 48098
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Ypsilanti, Michigan, United States, 48197
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Tupelo, Mississippi, United States, 38801
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Kansas City, Missouri, United States, 64111
United States, Montana
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Missoula, Montana, United States, 59808
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Linden, New Jersey, United States, 07036
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Lodi, New Jersey, United States, 07644
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New Brunswick, New Jersey, United States, 08901
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Westwood, New Jersey, United States, 07675
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Albany, New York, United States, 12206
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Buffalo, New York, United States, 14215
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Mineola, New York, United States, 11501
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New Windsor, New York, United States, 12553
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Rosedale, New York, United States, 11422
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Syracuse, New York, United States, 13202
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Charlotte, North Carolina, United States, 28277
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Fargo, North Dakota, United States, 58103
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Cincinnati, Ohio, United States, 45227
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Cincinnati, Ohio, United States, 45246
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Cincinnati, Ohio, United States, 45212
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Cincinnati, Ohio, United States, 45219
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Marion, Ohio, United States, 43302
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Perrysburg, Ohio, United States, 43551
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Sandusky, Ohio, United States, 44870
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Norman, Oklahoma, United States, 73069
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Hillsboro, Oregon, United States, 97123
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Downingtown, Pennsylvania, United States, 19335-2620
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Houston, Texas, United States, 77062
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Houston, Texas, United States, 77081
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Houston, Texas, United States, 77070
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New Braunfels, Texas, United States, 78130
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Pasadena, Texas, United States, 77504
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San Antonio, Texas, United States, 78215
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San Antonio, Texas, United States, 78249
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Tomball, Texas, United States, 77375
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Burien, Washington, United States, 98166
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Wenatchee, Washington, United States, 98801
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Australia, Queensland
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Milton, Queensland, Australia, 4064
Belgium
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Brussels, Belgium, 1090
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Genk, Belgium, 3600
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Huy, Belgium, 4500
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Leuven, Belgium, 3000
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Tienen, Belgium, 3300
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Zottegem, Belgium, 9620
Canada, Ontario
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Brampton, Ontario, Canada, L6S 0C9
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Cambridge, Ontario, Canada, N1R 7R1
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Markham, Ontario, Canada, L6B 0P9
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Newmarket, Ontario, Canada, L3Y 8C3
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Oakville, Ontario, Canada, L6H 3P1
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Sarnia, Ontario, Canada, N7T 4X3
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Thornhill, Ontario, Canada, L4J 8L7
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Thunder Bay, Ontario, Canada, P7B 7C7
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Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
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Chicoutimi, Quebec, Canada, G7H 7Y8
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Drummondville, Quebec, Canada, J7B 7T1
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Laval, Quebec, Canada, H7T 2P5
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Montreal, Quebec, Canada, H4N 2W2
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Montreal, Quebec, Canada, H1T 1C8
Canada
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Quebec, Canada, G1V 4M6
Colombia
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Barranquilla, Atlantico, Colombia
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Cartagena, Bolivar, Colombia, 130010
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Cartagena, Bolivar, Colombia
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Bogota D.C., Cundinamarca, Colombia, 00000
Czech Republic
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Hradec Kralove, Czech Republic, 500 05
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Praha 1, Czech Republic, 110 00
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Praha 5, Czech Republic, 158 00
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Zlin, Czech Republic, 760 01
Finland
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Helsinki, Finland, 00920
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Helsinki, Finland, 00029
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Jyvaskyla, Finland, 40620
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Kerava, Finland, 04200
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Kuopio, Finland, 70210
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Kuopio, Finland, 70100
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Oulu, Finland, 90029
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Oulu, Finland, 90100
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Tampere, Finland, 33520
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Valkeakoski, Finland, 37600
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Vantaa, Finland, 01600
France
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Tourcoing, Nord Pas-De-Calais, France, 59200
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Cannes Cedex, France, 06414
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Corbeil-Essonnes, France, 91106
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Lille, France, 59000
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Pau, France, 64046
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Rosiers d'Egletons, France, 19300
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Valenciennes, France, 59300
Germany
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Berlin, Germany, 10115
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Berlin, Germany, 13125
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Bielefeld, Germany, 33604
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Dortmund, Germany, 44227
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Hannover, Germany, 30159
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Jena, Germany, 07747
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Munich, Germany, 81737
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Schwerin, Germany, 19055
Hungary
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Balatonfured, Hungary, 8230
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Budapest, Hungary, 1088
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Budapest, Hungary, 1097
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Nyiregyhaza, Hungary, 4400
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Zalaegerszeg, Hungary, 8900
Israel
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Givatayim, Israel, 53583
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Haifa, Israel, 31096
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Ramat Gan, Israel, 52621
Italy
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Milano, MI, Italy, 20138
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Roma, RM, Italy, 00161
Korea, Republic of
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
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Daegu, Korea, Republic of, 705-718
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Daejeon, Korea, Republic of, 302-718
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Gyeonggi-do, Korea, Republic of, 420-717
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Seoul, Korea, Republic of, 156-707
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 135-720
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Seoul, Korea, Republic of, 134-701
Netherlands
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Breda, Netherlands, 4811 SW
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Dirksland, Netherlands, 3247 BW
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Dordrecht, Netherlands, 3318 AT
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Rotterdam, Netherlands, 3021
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Rotterdam, Netherlands, 3039 BD
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Venlo, Netherlands, 5912 BL
Poland
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Lublin, Iubelskie, Poland, 20-044
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Lodz, Lodzkie, Poland, 92-003
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Warszawa, Mazowieckie, Poland, 00-415
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Sopot, Pomorskie, Poland, 81-756
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Starogard Gdanski, Pomorskie, Poland, 83-200
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Katowice, Slaskie, Poland, 40-954
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Kielce, Swietokrzyskie, Poland, 25-315
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Gdansk, Poland, 80-126
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Gdynia, Poland, 81-472
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Gdynia, Poland, 81-338
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Katowice, Poland, 40-752
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Krakow, Poland, 30-015
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Opole, Poland, 45-706
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Ostroda, Poland, 14-100
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Piotrkow Trybunalski, Poland, 97-300
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Poznan, Poland, 60-539
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Ruda Slaska, Poland, 41-709
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Skierniewice, Poland, 96-100
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Warszawa, Poland, 01-518
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Warszawa, Poland, 01-868
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Warszawa, Poland, 04-628
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Wroclaw, Poland, 51-124
Puerto Rico
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San Juan, Puerto Rico, 00926-2832
Romania
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Cluj-Napoca, jud. Cluj, Romania, 400006
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Timisoara, judet Timis, Romania, 300456
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Targu Mures, Romania, 540142
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Tg. Mures, Romania, 540142
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Timisoara, Romania, 300125
Slovakia
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Bardejov, Slovakia, 08501
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Bratislava, Slovakia, 83101
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Dolny Kubin, Slovakia, 02601
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Nove Zamky, Slovakia, 940 34
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Zilina, Slovakia, 01001
South Africa
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Arcadia, Pretoria, South Africa, 0001
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Bloemfontein, South Africa, 9301
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Centurion, South Africa, 0157
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Houghton, South Africa, 2198
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Merebank, Durban, South Africa, 4052
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Paarl, South Africa, 7646
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Parow, South Africa, 7500
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Somerset West, South Africa, 7130
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Witbank (eMalahleni), South Africa, 1035
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Worcester, South Africa, 6850
Spain
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Malaga, Andalucia, Spain, 29010
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Alicante, Comunidad Valenciana, Spain, 03550
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Granada, Granada (Andalucía), Spain, 18012
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Palma de Mallorca, Islas Baleares, Spain, 07014
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Requena, Valencia, Spain, 46340
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A Coruna, Spain, 15006
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Barcelona, Spain, 08025
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Barcelona, Spain, 08003
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Barcelona, Spain, 08003
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Cordoba, Spain, 14004
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Granada, Spain, 18014
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Granada, Spain, 18012
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Madrid, Spain, 28034
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Madrid, Spain, 28034
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Sevilla, Spain, 41013
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Sevilla, Spain, 41009
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Valencia, Spain, 46014
Taiwan
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Kaohsiung City, Taiwan, 82445
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New Taipei City, Taiwan, 23148
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Taichung, Taiwan, 40447
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Taichung, Taiwan, 406
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Tainan, Taiwan, 704
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Taipei, Taiwan, 10449
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 112
United Kingdom
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Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
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Romford, Essex, United Kingdom, RM7 0AG
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Oldham, Greater Manchester, United Kingdom, OL1 2JH
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Stevenage, Hertfordshire, United Kingdom, SG1 4AB
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Welwyn Garden City, Hertfordshire, United Kingdom, AL7 4HQ
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Blackpool, Lancashire, United Kingdom, FY3 7EN
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East Sussex, United Kingdom, TN39 4SP
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Glasgow, United Kingdom, G11 6NT
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Glasgow, United Kingdom, G12 8TA
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London, United Kingdom, EC1M 6BQ
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London, United Kingdom, EC1A 7BE
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Wiltshire, United Kingdom, BA12 9AA
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01975389     History of Changes
Other Study ID Numbers: B1481038, CV OUTCOMES 2
Study First Received: October 21, 2013
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
myocardial infarction
stroke
hyperlipidemia

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014