Study Stopped
See termination reason in detailed description.
Extension Study Of Tanezumab In Osteoarthritis
A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
2 other identifiers
interventional
2,147
1 country
226
Brief Summary
Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2009
226 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
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedStudy Start
First participant enrolled
February 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2011
CompletedResults Posted
Study results publicly available
May 10, 2021
CompletedMay 10, 2021
April 1, 2021
1.7 years
December 16, 2008
January 29, 2021
April 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
AE:any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE:an AE resulting in any of following outcomes or deemed significant for any other reason:death;initial or prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent or significant disability/incapacity;congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)
Number of Participants With Abnormal Laboratory Findings
Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(\<)0.8\*lower limit of normal(LLN),MCV,MCH,MCHC\<0.9\*LLN or \>1.1\*ULN,platelet:\<0.5\*LLN or \>1.75\*upper limit of normal(ULN),white blood cell(WBC):\<0.6\*LLN or \>1.5\*ULN,lymphocyte,neutrophil,total neutrophil:\<0.8\*LLN or\>1.2\*ULN,basophil,eosinophil,monocyte:\>1.2\*ULN;total,direct bilirubin\>1.5\*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:\> 3.0\*ULN,total protein,albumin:\<0.8\*LLN or \>1.2\*ULN;blood urea nitrogen,creatinine:\>1.3\*ULN,uric acid\>1.2\*ULN;cholesterol,triglycerides\>1.3\*ULN;sodium \<0.95\*LLN or \>1.05\*ULN,potassium,chloride,calcium,magnesium,bicarbonate:\<0.9\*LLN or \>1.1\*ULN,phosphate\<0.8\*LLN or\>1.2\*ULN;glucose \<0.6\*LLN or \>1.5\*ULN,glycosylated Hgb \>1.3\*ULN,creatine kinase\>2.0\*ULN;urine(specific gravity \<1.003or\>1.030,pH \<4.5or\>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals\>=1,RBC,WBC \>1.5\*ULN,epithelial cell\>=6,casts,hyaline cast\>1,bacteria\>20).
A4091016: Day 1 up to Week 80
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and VR interval. Number of participants with clinically significant abnormal ECG findings were judged by investigator and reported as adverse events were presented.
A4091016: Baseline (Day 1) up to Week 80
Secondary Outcomes (17)
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)
Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings
Baseline (Day 1) up to Week 80
Number of Participants With Clinically Significant Abnormality in Vital Signs
A4091016: Baseline (Day 1) up to Week 80
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
- +12 more secondary outcomes
Other Outcomes (1)
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
A4091016: Baseline (Day 1) up to Week 64
Study Arms (3)
Tanezumab 10 mg
EXPERIMENTALTanezumab 10 mg
Tanezumab 5 mg
EXPERIMENTALTanezumab 5 mg
Tanezumab 2.5 mg
EXPERIMENTALTanezumab 2.5 mg
Interventions
Eligibility Criteria
You may qualify if:
- Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis
You may not qualify if:
- Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (226)
Pinncale Research Group, LLC
Anniston, Alabama, 36201, United States
Anniston Medical Clinic, PC
Anniston, Alabama, 36207, United States
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Greystone Medical Center
Birmingham, Alabama, 35242, United States
Saadat Ansari, MD Office
Huntsville, Alabama, 35801, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Horizon Research Group
Mobile, Alabama, 36608, United States
Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
Mesa, Arizona, 85203, United States
Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC
Mesa, Arizona, 85206, United States
Novara Clinical Research
Mesa, Arizona, 85206, United States
Clinical Research Advantage, Inc.
Mesa, Arizona, 85213, United States
Arizona Arthritis & Rheumatology Research, PLLC
Paradise Valley, Arizona, 85253, United States
Pivotal Research Center
Peoria, Arizona, 85381, United States
Clincial Research Advantage, Inc/Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, 85020, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Clinical Research Advantage, Inc.
Phoenix, Arizona, 85028, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, 85037, United States
Paradigm Clinical, Inc.
Tucson, Arizona, 85712, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, 85712, United States
Quality of Life Medical and Research Center
Tucson, Arizona, 85712, United States
Tucson Orthopaedic Institute
Tucson, Arizona, 85712, United States
University of Arizona
Tucson, Arizona, 85724, United States
St. Joseph's Mercy Clinic
Hot Springs, Arkansas, 71913, United States
Osteoporosis Medical Center
Beverly Hills, California, 90211, United States
Providence Clinical Research
Burbank, California, 91505, United States
eStudySite
Chula Vista, California, 91911, United States
Colorado Hematology - Oncology
Englewood, California, 80110, United States
Colorado Orthopedic Consultants, PC
Englewood, California, 80110, United States
Arthritis Medical Clinic of North County, Inc.
Escondido, California, 92025, United States
Edinger Medical Group Clinical Research
Fountain Valley, California, 92708, United States
Valley Research
Fresno, California, 93720, United States
Talbert Medical Group
Huntington Beach, California, 92646, United States
Lakewood Orthopedic Medical & Surgical Group
Lakewood, California, 90712, United States
High Desert Medical Group Research for Life
Lancaster, California, 93534, United States
Premiere Clinical Research, LLC
Long Beach, California, 90807, United States
Samaritan Center for Medical Research
Los Gatos, California, 95032, United States
Del Carmen Medical Center
Reseda, California, 91335, United States
Probe Clinical Research, Corp.
Santa Ana, California, 92701, United States
Trinity Clinical Trials
Santa Ana, California, 92701, United States
Office of Lawrence P McAdam, MD
Thousand Oaks, California, 91360, United States
Westlake Medical Research
Westlake Village, California, 91361, United States
Colorado Orthopedic Consultants, PC
Aurora, Colorado, 80012, United States
Peak Anesthesia and Pain Management
Centennial, Colorado, 80112, United States
Denver Internal Medicine Group
Denver, Colorado, 80209, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, 80209, United States
Advanced Orthopedic and Sports Medicine
Denver, Colorado, 80230, United States
American Clinical Research, LLC
Englewood, Colorado, 80113, United States
Orthopaedic Physicians Of Colorado, P.C.
Englewood, Colorado, 80113, United States
University Parks Hematology/Oncology
Englewood, Colorado, 80113, United States
Advanced Orthopedic and Sports Medicine
Parker, Colorado, 80134, United States
Clinical Research Center of Connecticut
Danbury, Connecticut, 06810, United States
Norwalk Medical Group
Norwalk, Connecticut, 06851, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Delaware Arthritis
Lewes, Delaware, 19958, United States
Javed Rheumatology Associates, Inc.
Newark, Delaware, 19713, United States
HeartCare (Private Practice)
Bradenton, Florida, 34202, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Arthritis Associates of South Florida
Delray Beach, Florida, 33484, United States
Delray Research Associates
Delray Beach, Florida, 33484, United States
In Vivo Clinical Research, Inc
Doral, Florida, 33166, United States
S & W Clinical Research
Fort Lauderdale, Florida, 33306, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33334, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Adult Medicine Specialists
Longwood, Florida, 32779, United States
Genesis Research International
Longwood, Florida, 32779, United States
Pharmax Research Clinic, Inc
Miami, Florida, 33126, United States
Kendall South Medical Center, Inc.
Miami, Florida, 33185, United States
Sunshine Research Center
Opa-locka, Florida, 33054-3818, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
University Clinical Research Incorporated
Pembroke Pines, Florida, 33024, United States
Advent Clinical Research Centers, Inc.
Pinellas Park, Florida, 33781, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
HeartCare Research
Sarasota, Florida, 34232, United States
Dale G. Bramlet, MD, P.L.
St. Petersburg, Florida, 33713, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321, United States
Tampa Medical Group, PA
Tampa, Florida, 33614, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Laureate Clinical Research Group
Atlanta, Georgia, 30308, United States
Arthritis and Rheumatology of Georgia
Atlanta, Georgia, 30342, United States
Laureate Clinical Research Group
Atlanta, Georgia, 30342, United States
Masters of Clinical Research, Inc.
Augusta, Georgia, 30909, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513, United States
Jefrey D. Lieberman, MD
Decatur, Georgia, 30033, United States
Early Family Practice Center
Fort Valley, Georgia, 31030, United States
Northeast Georgia Diagnostic Clinic, LLC
Gainesville, Georgia, 30501, United States
Marietta Rheumatology Associates
Marietta, Georgia, 30060, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
North Georgia Internal Medicine
Woodstock, Georgia, 30189, United States
Sonora Clinical Research, LLC.
Boise, Idaho, 83702, United States
Millennium Pain Center
Bloomington, Illinois, 61701, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Koch Family Medicine
Morton, Illinois, 61550, United States
Illinois Bone and Joint Institute, LLC
Morton Grove, Illinois, 60053, United States
The Arthritis Center
Springfield, Illinois, 62704, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
American Health Network
Fishers, Indiana, 46038, United States
Memorial Medical Group Clinical Research Institute
South Bend, Indiana, 46601, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203, United States
Pasadena Pharmacy
Lexington, Kentucky, 40503, United States
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, 40503, United States
Arthritis Center of Lexington
Lexington, Kentucky, 40504, United States
Bluegrass Community Research, Inc
Lexington, Kentucky, 40515, United States
David H. Neustadt, MD
Louisville, Kentucky, 40202, United States
L-Marc Research Center
Louisville, Kentucky, 40213, United States
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, 70808, United States
The Baton Rouge Clinic
Baton Rouge, Louisiana, 70808, United States
Stanocola Medical Center
Baton Rouge, Louisiana, 70816, United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, 71203, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Arthritis Treatment Center
Frederick, Maryland, 21702, United States
Mid-Atlantic Medical Research Centers
Hollywood, Maryland, 20636, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
Miray Medical Center
Brockton, Massachusetts, 02301, United States
Mansfield Health Center
Mansfield, Massachusetts, 02048, United States
Arthritis Associates Inc.
Peabody, Massachusetts, 01960, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Ann Arbor Clinical Research
Ann Arbor, Michigan, 48103, United States
Great Lakes Research Group, Incorporated
Bay City, Michigan, 48706, United States
KMED Research
Saint Clair Shores, Michigan, 48081, United States
MAPS Applied Research Center Inc.
Edina, Minnesota, 55435, United States
Medical Advanced Pain Specialists
Edina, Minnesota, 55435, United States
Planters Clinic
Port Gibson, Mississippi, 39150, United States
St. John's Clinic - Neurology
Springfield, Missouri, 65804, United States
St. John's Medical Research Institute, Inc.
Springfield, Missouri, 65807, United States
Medex Healthcare Research
St Louis, Missouri, 63117, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Midwest Minor Medical
Omaha, Nebraska, 68114, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Midwest Minor Medical
Omaha, Nebraska, 68127, United States
Midwest Minor Medical
Omaha, Nebraska, 68144, United States
Diagnostic Center of Medicine
Henderson, Nevada, 89052, United States
Independent Clinical Researchers
Las Vegas, Nevada, 89103, United States
Wolfson Medical Center
Las Vegas, Nevada, 89103, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
Mirkil Medical
Las Vegas, Nevada, 89119, United States
G. Timothy Kelly, MD
Las Vegas, Nevada, 89128, United States
Office of Dr. Danka Michaels, MD
Las Vegas, Nevada, 89128, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
New Mexico Clinical Research & Osteoporosis Center, Incorporated
Albuquerque, New Mexico, 87106, United States
Arthritis and Osteoporosis Medical Associates
Brooklyn, New York, 11201, United States
Medex Healthcare Research
New York, New York, 10022, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
Prem C. Chatpar, MD, LLC
Plainview, New York, 11803, United States
AAIR Research Center
Rochester, New York, 14618, United States
Office of Dr. Andrew Porges
Roslyn, New York, 11576-1507, United States
SPRI Bronx LLC
The Bronx, New York, 10454, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207-1198, United States
Carolina Bone & Joint, PA
Charlotte, North Carolina, 28210, United States
Pharmquest
Greensboro, North Carolina, 27408, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Odyssey Research
Fargo, North Dakota, 58104, United States
Plains Medical Clinic, LLC
Fargo, North Dakota, 58104, United States
Consultants for Clinical Research Incorporated
Cincinnati, Ohio, 45219, United States
Ohio GI and Liver Institute
Cincinnati, Ohio, 45219, United States
Hilltop Medical Research Center
Cincinnati, Ohio, 45224, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, 43213, United States
PHP Center for Clinical Research
Dayton, Ohio, 45439, United States
Paramount Medical Research and Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
Orthopaedic & Sports Medicine Consultants
Middletown, Ohio, 45042, United States
Signal Point Clinical Research Center
Middletown, Ohio, 45042, United States
Pharmacotherapy Research Associates,Inc
Zanesville, Ohio, 43701, United States
Physicians' Research, Inc
Zanesville, Ohio, 43701, United States
Primecare of Southeastern Ohio, Inc
Zanesville, Ohio, 43701, United States
Cor Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, 18015-1153, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335-2620, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, 19610, United States
Low Country Rheumatology, PA
Charleston, South Carolina, 29406, United States
The Family Healthcare Center, PA
Clinton, South Carolina, 29325, United States
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, 29204, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
The Carolina Center for Rheumatology and Arthritis Care, PA
Rock Hill, South Carolina, 29732, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
State of Franklin Healthcare Associates, PLLC
Johnson City, Tennessee, 37604, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Capitol Medical Clinic
Austin, Texas, 78705, United States
Walter F. Chase, MD, PA
Austin, Texas, 78705, United States
Tekton Research, Inc.
Austin, Texas, 78745, United States
North Texas Joint Care, PA
Dallas, Texas, 75230, United States
Crown Imaging
Dallas, Texas, 75231, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Radiant Research
Dallas, Texas, 75231, United States
O. David Taunton, Jr, MD
Grapevine, Texas, 76051, United States
Asif Cochinwala, MD, PA
Houston, Texas, 77008, United States
Foundation for Southwest Orthopedic Research
Houston, Texas, 77030, United States
One Step Diagnostic
Houston, Texas, 77030, United States
Southwest Orthopedic Group
Houston, Texas, 77030, United States
The Neurology Center
Houston, Texas, 77030, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77036, United States
Gill Orthopedic Center
Lubbock, Texas, 79410, United States
Robert R. King, M.D.
Lubbock, Texas, 79410, United States
Clinical Investigations of Texas, LLC
Plano, Texas, 75075, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, 78217, United States
Texas Arthritis Research Center, PA
San Antonio, Texas, 78217, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Spring Family Practice Associates PA
Spring, Texas, 77379, United States
AZ Clinical Research
Sugar Land, Texas, 77478, United States
Spring Clinical Research
Sugar Land, Texas, 77478, United States
Sugar Land Med-Ped, P.A.
Sugar Land, Texas, 77479, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Aspen Clinical Research
Orem, Utah, 84058, United States
Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Incorporated/Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Commonwealth Orthopaedics and Rehabilitation, PC
Arlington, Virginia, 22205, United States
IntegraTrials, LLC
Arlington, Virginia, 22205, United States
Virginia Hospital Center
Arlington, Virginia, 22205, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502, United States
Office of Doris M. Rice, MD, FACR
Portsmouth, Virginia, 23701, United States
HhypotheTest, LLC
Roanoke, Virginia, 24018, United States
Empirical Clinical Trials
Selah, Washington, 98942, United States
Arthritis Northwest
Spokane, Washington, 99204-2336, United States
Clinical Trials Northwest
Yakima, Washington, 98902, United States
Related Publications (1)
Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.
PMID: 26554876DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to FDA imposed clinical hold, enrollment was stopped prematurely and, therefore, not all study procedures and visits occurred as planned.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2008
First Posted
December 17, 2008
Study Start
February 6, 2009
Primary Completion
November 2, 2010
Study Completion
June 23, 2011
Last Updated
May 10, 2021
Results First Posted
May 10, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.