Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness
ADOPT
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
1 other identifier
interventional
6,758
34 countries
294
Brief Summary
The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2007
Typical duration for phase_3
294 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2007
CompletedFirst Posted
Study publicly available on registry
April 5, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
May 20, 2014
CompletedDecember 8, 2015
May 1, 2014
3.9 years
April 4, 2007
April 14, 2014
December 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population
VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N\*100 (n=number with observation; N=total efficacy evaluable participants).
Intended Treatment Period
Incidence of Major Bleeding During the Treatment Period in Treated Participants
Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N\*100 (n=number with observation; N=total efficacy evaluable participants).
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N\*100 (n=number with observation; N=total efficacy evaluable participants).
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N\*100 (n=number with observation; N=total efficacy evaluable participants).
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Incidence of All Bleeding During the Treatment Period in Treated Participants
Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N\*100 (n=number with observation; N=total efficacy evaluable participants).
Day 1, first dose of drug to last dose of drug plus 2 days
Secondary Outcomes (27)
Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants
Day 1 to last dose of parenteral study drug plus 1 day
Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants
Day 1 to last dose of parenteral study drug plus 1 day
Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period
Intended Treatment Period
Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period
Intended Treatment Period
Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period
Intended Treatment Period
- +22 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALWhile hospitalized, Apixaban plus Placebo Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC) After hospital discharge, Apixaban Apixaban (Tablets, Oral, 2.5 mg)
Arm 2
ACTIVE COMPARATORWhile hospitalized, Enoxaparin plus Placebo Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral) After hospital discharge: Placebo Placebo (Tablets, Oral)
Interventions
Apixaban: Twice daily, 30 days Placebo: Once daily, 6-14 days
Eligibility Criteria
You may qualify if:
- men and non-pregnant, non-breastfeeding women
- years or older
- hospitalized with congestive heart failure or acute respiratory failure
- infection (without septic shock)
- acute rheumatic disorder
- inflammatory bowel disease
You may not qualify if:
- patients with venous thromboembolism (VTE)
- active bleeding or at high risk of bleeding
- unable to take oral medication
- with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (296)
University Of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294, United States
Heart Center Research, Llc
Huntsville, Alabama, 35801, United States
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, 85013, United States
Az Pulmonary Specialists Ltd
Scottsdale, Arizona, 85258, United States
Fort Smith Lung Center
Fort Smith, Arkansas, 72901, United States
Scripps Clinic/Scripps Health And Green Hospital
La Jolla, California, 92037, United States
Va Long Beach Healthcare System
Long Beach, California, 90822, United States
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Dr. Felt Medical Office
Oakland, California, 94609, United States
Stanford University
Stanford, California, 94305, United States
Yale University School Of Medicine
New Haven, Connecticut, 06510, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Florida Hospital Celebration Health
Celebration, Florida, 34747, United States
Research Alliance, Inc.
Clearwater, Florida, 33756, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, 32216, United States
Pensacola Lung Group
Pensacola, Florida, 32504, United States
Indian River Med. Ctr.
Vero Beach, Florida, 32960, United States
Atlanta Institute For Medical Research, Inc
Atlanta, Georgia, 30030, United States
Pulmonary & Critical Care Of Atlanta
Atlanta, Georgia, 30342, United States
Idaho Falls Infectious Diseases, Pllc
Idaho Falls, Idaho, 83404, United States
West Suburban Hospital
Oak Park, Illinois, 60302, United States
Infectious Disease Of Indiana Psc
Carmel, Indiana, 46032, United States
Cotton-O-Neil Clinical Research Center
Topeka, Kansas, 66604, United States
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, 71103, United States
Johns Hopkins University School Of Medicine
Baltimore, Maryland, 21205, United States
Franklin Square Hospital
Baltimore, Maryland, 21237, United States
Henry Ford Hospital, Transplant Institute
Detriot, Michigan, 48202, United States
University Of Missouri-Columbia
Columbia, Missouri, 65212, United States
Mercury Street Medical Group, Pllc
Butte, Montana, 59701, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Morristown Memorial Hospital
Mornstown, New Jersey, 07962, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
Mission Hospital, Inc
Asheville, North Carolina, 28801, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
The Milton S Hershey Medical Center Of Penn. State Univ.
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Palmetto Nephrology Pa
Orangeburg, South Carolina, 29118, United States
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303, United States
Texas Health Presbyterian Dallas
Dallas, Texas, 75231, United States
Michael E. De Bakey Veteran Affairs Medical Center
Houston, Texas, 77030, United States
Sonterra Clinical Research
San Antonio, Texas, 78205, United States
Sonterra Clinical Research
San Antonio, Texas, 78258, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University Of Utah Medical Center
Salt Lake City, Utah, 84132, United States
Mcguire Va Medical Center
Richmond, Virginia, 23249, United States
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Buenos Aires, Buenos Aires, C1181ACH, Argentina
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Ciudad Autonoma Buenos Aires, Buenos Aires, C1280AEB, Argentina
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Coronel Suárez, Buenos Aires, B7540GHD, Argentina
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Derqui-Pilar, Buenos Aires, B1629ODT, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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Munro, Buenos Aires, B1605DSX, Argentina
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San Martín, Buenos Aires, B1650CSQ, Argentina
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Corrientes, Corrientes Province, 3400, Argentina
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Córdoba, Córdoba Province, 5000, Argentina
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Córdoba, Córdoba Province, X5006IKK, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, S2002KDS, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000JCU, Argentina
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Concord, New South Wales, 2139, Australia
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St Leonards, New South Wales, 2065, Australia
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Kippa-Ring, Queensland, 4021, Australia
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Woolloongabba, Queensland, 4102, Australia
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Bedford Park, South Australia, 5042, Australia
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Woodville, South Australia, 5011, Australia
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Box Hill, Victoria, 3128, Australia
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Parkville, Victoria, 3050, Australia
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Ringwood East, Victoria, 3135, Australia
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Graz, 8036, Austria
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Vienna, 1090, Austria
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Ottignies, Waals-Brabant, 1340, Belgium
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Antwerp, 2060, Belgium
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Brasschaat, 2930, Belgium
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Brussels, 1070, Belgium
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Huy, 4500, Belgium
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Leuven, 3000, Belgium
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Belo Horizonte, Minas Gerais, 30150, Brazil
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Curitiba, Paraná, 80010, Brazil
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Curitiba, Paraná, 80810, Brazil
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Porto Alegre, Rio Grande do Sul, 90020, Brazil
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Porto Alegre, Rio Grande do Sul, 91430, Brazil
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Botucatu, São Paulo, 18618, Brazil
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Campinas, São Paulo, 13059, Brazil
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São José do Rio Preto, São Paulo, 15091, Brazil
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São Paulo, São Paulo, 04012, Brazil
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São Paulo, São Paulo, 04020, Brazil
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São Paulo, São Paulo, 04025, Brazil
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São Paulo, São Paulo, 05403, Brazil
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Ajax, Ontario, L1S 7K8, Canada
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Hamilton, Ontario, L8N 3Z5, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Windsor, Ontario, N8X 5A6, Canada
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Windsor, Ontario, N9A 1C9, Canada
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Granby, Quebec, J2G 1T7, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Temuco, Región de la Araucanía, Chile
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Rancagua, Región de Valparaíso, Chile
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Santiago, Santiago Metropolitan, 7500922, Chile
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Santiago, Santiago Metropolitan, 8207257, Chile
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Bogotá, Colombia
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Bucaramanga, Colombia
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Medellín, Colombia
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Brno, 656 91, Czechia
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Jindřichův Hradec, 377 38, Czechia
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Kladno, 272 59, Czechia
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Kyjov, 697 01, Czechia
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Ostrava, 728 80, Czechia
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Prague, 110 00, Czechia
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Prague, 128 08, Czechia
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Prague, 150 06, Czechia
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Ústí nad Labem, 401 13, Czechia
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Aalborg, 9100, Denmark
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Aarhus N, 8200, Denmark
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Arhus C, 8000, Denmark
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Frederiksberg, 2000, Denmark
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Glostrup Municipality, 2600, Denmark
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Hellerup, 2900, Denmark
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Herlev, 2730, Denmark
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Herning, 7400, Denmark
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Hvidovre, 2650, Denmark
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Odense, 5000, Denmark
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Randers NØ, 8930, Denmark
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Silkeborg, 8600, Denmark
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Bordeaux, 33075, France
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Brest, 29200, France
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Brest, 29609, France
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Dijon, 21079, France
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Grenoble, 38043, France
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Lille, 59020, France
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Nancy, 54035, France
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Nîmes, 30029, France
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Paris, 75475, France
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Paris, 75908, France
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Saint-Etienne, 42055, France
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Vernon, 27207, France
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Bonn, 53127, Germany
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Coburg, 96450, Germany
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Darmstadt, 64283, Germany
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Dresden, 01099, Germany
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Dresden, 01307, Germany
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Hanover, 30625, Germany
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Karlsbad, 76307, Germany
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Lübeck, 23538, Germany
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Mannheim, 68167, Germany
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Offenbach, 63069, Germany
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Witten, 58455, Germany
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Shatin, N.T., Hong Kong
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Budapest, 1135, Hungary
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Debrecen, 4032, Hungary
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Dunaújváros, 2400, Hungary
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Eger, 3300, Hungary
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Hyderabad, Andhra Pradesh, 500004, India
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Visakhapatnam, Andhra Pradesh, 530002, India
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Ahemdabad, Gujarat, 380054, India
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Bangalore, Karnataka, 560034, India
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Indore, Madhya Pardesh, 452018, India
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Pune, Maharashtra, 411001, India
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Pune, Maharashtra, 411004, India
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Ludhiana, Punjab, 141001, India
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Chennai, Tamil Nadu, 600096, India
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Coimbatore, Tamil Nadu, 641004, India
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Madurai, Tamil Nadu, 625107, India
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Noida, Uttar Pradesh, 201301, India
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Ahmedabad, 380054, India
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Bangalore, 560017, India
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Bangalore, 560054, India
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Hyderabad, 500033, India
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Mumbai, 400008, India
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New Delhi, 110025, India
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Afula, 18101, Israel
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Ashkelon, 78308, Israel
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Beersheba, 84105, Israel
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Haifa, 31096, Israel
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Petah Tikva, 49100, Israel
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Safed, 13110, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Ẕerifin, 70300, Israel
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Chieti Scalo, 66013, Italy
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Cremona, 26100, Italy
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Padua, 35128, Italy
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Piacenza, 29100, Italy
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Reggio Emilia, 42100, Italy
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Treviso, 31100, Italy
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Vicenza, 36100, Italy
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Kubang Kerian, Kelantan, 16150, Malaysia
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Batu Caves, Selangor, 68100, Malaysia
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Johor Bahru, 80100, Malaysia
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Mexico City, Mexico City, 06726, Mexico
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Mexico City, Mexico City, 07760, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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Querétaro City, Querétaro, 76178, Mexico
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San Luis Potosí City, San Luis Potosí, 78220, Mexico
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Xalapa, Veracruz, 91020, Mexico
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Mérida, Yucatán, 97129, Mexico
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Den Helder, 1782 GZ, Netherlands
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Kongsvinger, 2226, Norway
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Lima, Lima Province, LIMA 01, Peru
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Lima, Lima Province, LIMA 11, Peru
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Lima, Lima Province, LIMA 1, Peru
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Lima, Lima Province, LIMA 31, Peru
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La Victoria, Lima region, LIMA 13, Peru
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Callao, Provincia Constitucional del Callao, CALLAO 2, Peru
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Arequipa, AREQUIPA54, Peru
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Cagayan de Oro, Misamis Oriental, 9000, Philippines
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Las Piñas, 1742, Philippines
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Quezon City, 1100, Philippines
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Quezon City, 1102, Philippines
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Quezon City, 1110, Philippines
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Bydgoszcz, 85-168, Poland
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Krakow, 31-202, Poland
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Lodz, 91-347, Poland
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Nowa Sól, 67-100, Poland
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Poznan, 61-833, Poland
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Skierniewice, 96-100, Poland
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Warsaw, 01-138, Poland
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Warsaw, 03-737, Poland
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Wejherowo, 84-200, Poland
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Zielona Góra, 65-046, Poland
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Moscow, 111539, Russia
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Moscow, 115280, Russia
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Moscow, 117292, Russia
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Moscow, 117593, Russia
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Moscow, 119991, Russia
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Moscow, 121309, Russia
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Moscow, 127018, Russia
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Moscow, 129336, Russia
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Odintsovo, 143000, Russia
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Podolsk, 142100, Russia
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Ryazan, 390005, Russia
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Saint Petersburg, 192242, Russia
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Saint Petersburg, 193312, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 198205, Russia
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Saint Petersburg, 199106, Russia
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Saratov, 410002, Russia
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Saratov, 410054, Russia
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Singapore, 308433, Singapore
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Singapore, 529889, Singapore
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Bloemfontein, Free State, 9301, South Africa
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Johannesburg, Gauteng, 2193, South Africa
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Pretoria, Gauteng, 0044, South Africa
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eManzimtoti, KwaZulu-Natal, 4120, South Africa
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Bellville, Western Cape, 7530, South Africa
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Groenkloof, 0181, South Africa
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Guri-si, Gyeonggi-do, 471-701, South Korea
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Seongnam-si, Gyeonggi-do, 463-707, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 136-705, South Korea
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Seoul, 137-040, South Korea
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Suwon, 443721, South Korea
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Torrevieja, Alicante, 03186, Spain
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Alcorcon(Madrid), 28922, Spain
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Barcelona, 08003, Spain
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Barcelona, 08036, Spain
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Madrid, 28006, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Seville, 41013, Spain
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Tarragona, 43007, Spain
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Gothenburg, 413 45, Sweden
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Lund, 221 85, Sweden
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Yung-Kang City, Tainan, 710, Taiwan
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Taichung, 402, Taiwan
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Istanbul, Capa, 34390, Turkey (Türkiye)
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Ankara, Dikimevi, 06100, Turkey (Türkiye)
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Istanbul, 34390, Turkey (Türkiye)
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Donetsk, 83003, Ukraine
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Kharkiv, 61018, Ukraine
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Kharkiv, 61039, Ukraine
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Kharkiv, 61176, Ukraine
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Kyiv, 01133, Ukraine
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Kyiv, 02091, Ukraine
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Kyiv, 03115, Ukraine
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Kyiv, 03151, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, 04050, Ukraine
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Kyiv, 04201, Ukraine
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Lutsk, 43024, Ukraine
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Lviv, 79010, Ukraine
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Uzhhorod, 88000, Ukraine
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Vinnitsa, 21029, Ukraine
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London, Greater London, SE5 9RS, United Kingdom
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London, Greater London, SW3 6LR, United Kingdom
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Uxbridge, Middlesex, UB8 3NN, United Kingdom
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Newcastle, Tyne and Wear, NE7 7DN, United Kingdom
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Dudley, West Midlands, DY1 2HQ, United Kingdom
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Hull, Yorkshire, HU3 2JZ, United Kingdom
Related Publications (4)
Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.
PMID: 28762617DERIVEDMarszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.
PMID: 28617144DERIVEDSharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.
PMID: 22863355DERIVEDGoldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.
PMID: 22077144DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2007
First Posted
April 5, 2007
Study Start
June 1, 2007
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
December 8, 2015
Results First Posted
May 20, 2014
Record last verified: 2014-05