Study Stopped
Solanezumab did not meet the primary endpoint in study H8A-MC-LZAX.
Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease
EXPEDITION EXT
Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease
2 other identifiers
interventional
1,457
16 countries
147
Brief Summary
This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2010
Longer than P75 for phase_3
147 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
May 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 21, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
May 3, 2018
CompletedOctober 8, 2019
September 1, 2019
3.6 years
May 19, 2010
February 12, 2018
September 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Baseline through Week 104
Secondary Outcomes (12)
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
Baseline, Week 104
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
Baseline, Week 104
Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Baseline, Week 104
Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)
Baseline, Week 104
Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours
Baseline, Week 104
- +7 more secondary outcomes
Study Arms (2)
Solanezumab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
Eligibility Criteria
You may qualify if:
- Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
- Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
- Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
- Must have good vein access to administer infusions
- Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO
You may not qualify if:
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (147)
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Phoenix, Arizona, 85006, United States
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Sun City, Arizona, 85351, United States
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Tucson, Arizona, 85718, United States
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Little Rock, Arkansas, 72211, United States
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Carson, California, 90746, United States
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Laguna Hills, California, 92653, United States
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Lomita, California, 90717, United States
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Los Angeles, California, 90073, United States
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Oxnard, California, 93030, United States
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San Diego, California, 92103, United States
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San Francisco, California, 94109, United States
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Santa Ana, California, 92705, United States
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Santa Monica, California, 90404, United States
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Denver, Colorado, 80239, United States
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Fairfield, Connecticut, 06824, United States
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Hamden, Connecticut, 06518, United States
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New Haven, Connecticut, 06510, United States
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Norwalk, Connecticut, 06851, United States
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Newark, Delaware, 19713, United States
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Washington D.C., District of Columbia, 20057, United States
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Boca Raton, Florida, 33431, United States
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Fort Myers, Florida, 33912, United States
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Hollywood, Florida, 33021, United States
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Miami, Florida, 33137, United States
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Miami Springs, Florida, 33166, United States
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Orange City, Florida, 32763, United States
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Orlando, Florida, 32806, United States
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Sunrise, Florida, 33351, United States
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Tampa, Florida, 33613, United States
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Atlanta, Georgia, 30341, United States
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Canton, Georgia, 30114, United States
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Decatur, Georgia, 30033, United States
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Indianapolis, Indiana, 46202, United States
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Lexington, Kentucky, 40503, United States
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Baltimore, Maryland, 21285, United States
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Rockville, Maryland, 20852, United States
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Belmont, Massachusetts, 02478, United States
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Traverse City, Michigan, 49684, United States
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Creve Coeur, Missouri, 63141, United States
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Albuquerque, New Mexico, 87109, United States
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Albany, New York, 12205, United States
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Amherst, New York, 14226, United States
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Brooklyn, New York, 11235, United States
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Latham, New York, 12210, United States
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New York, New York, 10032, United States
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Staten Island, New York, 10312, United States
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Raleigh, North Carolina, 27607, United States
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Winston-Salem, North Carolina, 27103, United States
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Beachwood, Ohio, 44122, United States
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Toledo, Ohio, 43623, United States
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Oklahoma City, Oklahoma, 73116, United States
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Eugene, Oregon, 97401, United States
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Portland, Oregon, 97210, United States
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Philadelphia, Pennsylvania, 19104, United States
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East Providence, Rhode Island, 02914, United States
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Charleston, South Carolina, 29425, United States
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Greer, South Carolina, 29650, United States
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Sioux Falls, South Dakota, 57105, United States
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Salt Lake City, Utah, 84108, United States
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Bennington, Vermont, 05201, United States
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Burlington, Vermont, 05401, United States
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Norfolk, Virginia, 23502, United States
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Roanoke, Virginia, 24018, United States
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Seattle, Washington, 98108, United States
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Buenos Aires, CBA 1419, Argentina
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Ciudad Automona de Buenos Aire, C1111AAL, Argentina
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Córdoba, X5004AOA, Argentina
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Mendoza, 5500, Argentina
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Rosario, S2000BZL, Argentina
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Santa Fe, S3000FWO, Argentina
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Gosford, New South Wales, 2250, Australia
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Kogarah, New South Wales, 2217, Australia
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Chermside, Queensland, 4032, Australia
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Toowoomba, Queensland, 4650, Australia
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Box Hill, Victoria, 3128, Australia
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Glen Iris, Victoria, 3146, Australia
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Heidelberg Heights, Victoria, 3081, Australia
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Melbourne, Victoria, 3004, Australia
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Subiaco, Western Australia, 6008, Australia
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Curitiba, 80060-900, Brazil
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Itapira, 13970-905, Brazil
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Porto Alegre, 90110-270, Brazil
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Rio de Janeiro, 22271-100, Brazil
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São Paulo, 04024-002, Brazil
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Medicine Hat, Alberta, T1B4E7, Canada
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Kelowna, British Columbia, V1Y3G5, Canada
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Penticton, British Columbia, V2A 5C8, Canada
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Ottawa, Ontario, K1N 5C8, Canada
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Toronto, Ontario, M6M 3Z5, Canada
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Greenfield Park, Quebec, J4V 2J2, Canada
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Sherbrooke, Quebec, J1H1Z1, Canada
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Paris, 75475, France
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Rennes, 35000, France
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Strasbourg, 67091, France
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Toulouse, 31300, France
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Berlin, 12203, Germany
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Hamburg, 22307, Germany
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Hanover, 30559, Germany
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Mannheim, 68165, Germany
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Munich, D-81675, Germany
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Regensburg, 93042, Germany
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Baggiovara, 41100, Italy
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Biella, 13900, Italy
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Chieti, 66013, Italy
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Genova, 16128, Italy
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Lido di Camaiore, 55043, Italy
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Milan, 20132, Italy
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Rome, 00186, Italy
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Aichi, 474-8511, Japan
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Ehime, 791-0295, Japan
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Fukuoka, 816-0864, Japan
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Hiroshima, 720-0825, Japan
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Hyōgo, 514-8507, Japan
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Kanagawa, 247-8533, Japan
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Kyoto, 607-8062, Japan
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Osaka, 545-8586, Japan
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Shizuoka, 424-0911, Japan
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Tokyo, 187-8551, Japan
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Bydgoszcz, 85-796, Poland
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Gliwice, 44-100, Poland
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Katowice, 40-588, Poland
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Krakow, 31-530, Poland
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Lublin, 20-954, Poland
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Warsaw, 01-211, Poland
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Chelyabinsk, 454091, Russia
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Saint Petersburg, 190021, Russia
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Incheon, 400-711, South Korea
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Seongnam-si, 463-707, South Korea
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Seoul, 143-729, South Korea
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Suwon, 443-721, South Korea
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Barcelona, 08014, Spain
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Getafe, 28905, Spain
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Madrid, 28006, Spain
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Plasencia, 10600, Spain
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Terrassa, 08221, Spain
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Jönköping, 551 85, Sweden
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Kalmar, 39185, Sweden
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Lund, 22241, Sweden
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Mölndal, 43135, Sweden
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Umeå, 901 85, Sweden
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Guishan, 33305, Taiwan
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Niaosong, 833, Taiwan
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Taipei, 112, Taiwan
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Uckfield, E Susx, TN225AW, United Kingdom
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Scotland, Glasgow, G20 0XA, United Kingdom
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London, Greater London, N195NX, United Kingdom
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Camberwell, London, SE5 8AF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2010
First Posted
May 21, 2010
Study Start
December 1, 2010
Primary Completion
July 1, 2014
Study Completion
February 1, 2017
Last Updated
October 8, 2019
Results First Posted
May 3, 2018
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.