1/7/2021
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`History of Changesfor Study: NCT00509795
`
`ES) v.s. National Library of Medicine
`ClinicalTrials.gov archive
`
`History of Changes for Study: NCT00509795
`
`Vascular Endothelial Growth Factor(VEGF)Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related
`Macular Degeneration(AMD)(VIEW1)
`
`Latest version (submitted December 20, 2012) on ClinicalTrials. gov
`
`e Astudyversion is represented by a rowin the table.
`
`e Select two study versions to compare. One each from columnsA and B.
`
`e Chooseeither the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only
`applies to the Protocol section of the study.
`
`e Click "Compare" to do the comparison and show the differences.
`
`e Select a version's Submitted Date link to see a rendering of the study for that version.
`
`e The yellow A/B choicesin the table indicate the study versions currently compared below.A yellow table row indicates the study version currently being viewed.
`
`e Hoveroverthe "Recruitment Status" to see howthe study's recruitment status changed.
`
`e Study edits or deletions are displayed in Feé.
`
`e Study additions are displayed in green.
`
`Study Record Versions
`
`[sion]A|&|Submit
`1
`O
`O
`July 31,2007 None (earliest Version on record)
`
`2
`
`O
`
`oO
`
`
`August 17,2007 Recruitment Status, Study Status and Contacts/Locations
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?7A=8&B=9&C=merged#StudyPageTop
`
`1/27
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`CELLTRION - EXHIBIT 1014
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`CELLTRION - EXHIBIT 1014
`
`
`
`History of Changesfor Study: NCT00509795
`
`ES) v.s. National Library of Medicine
`ClinicalTrials.gov archive
`
`History of Changes for Study: NCT00509795
`
`Vascular Endothelial Growth Factor(VEGF)Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related
`Macular Degeneration(AMD)(VIEW1)
`
`Latest version (submitted December 20, 2012) on ClinicalTrials. gov
`
`e Astudyversion is represented by a rowin the table.
`
`e Select two study versions to compare. One each from columnsA and B.
`
`e Chooseeither the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only
`applies to the Protocol section of the study.
`
`e Click "Compare" to do the comparison and show the differences.
`
`e Select a version's Submitted Date link to see a rendering of the study for that version.
`
`e The yellow A/B choicesin the table indicate the study versions currently compared below.A yellow table row indicates the study version currently being viewed.
`
`e Hoveroverthe "Recruitment Status" to see howthe study's recruitment status changed.
`
`e Study edits or deletions are displayed in Feé.
`
`e Study additions are displayed in green.
`
`Study Record Versions
`
`[sion]A|&|Submit
`1
`O
`O
`July 31,2007 None (earliest Version on record)
`
`2
`
`O
`
`oO
`
`
`August 17,2007 Recruitment Status, Study Status and Contacts/Locations
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?7A=8&B=9&C=merged#StudyPageTop
`
`1/27
`
`CELLTRION - EXHIBIT 1014
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`CELLTRION - EXHIBIT 1014
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`
`
`1/7/2021
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`History of Changes for Study: NCT00509795
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`pee*Ts|semmeon
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`November 14,2007
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`Contacts/Locations and Study Status
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`
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`December4.2007Study Status and Contacts/Locations
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`March 13, 2008
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`Study Status and Eligibility
`
`June 26,2008
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`Contacts/Locations, Arms and Interventions, Study Design, Study Status, Outcome Measures and Study
`Identification
`
`January 22,2009
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`Contacts/Locations, Study Status, Armsand Interventions, Outcome Measures,Eligibility and
`Sponsor/Collaborators
`
`March 3, 2009
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`Study Status and Contacts/Locations
`
`Anil28,.2009
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`Outcome Measures, Arms and Interventions, Study Status, Eligibility, Conditions and Study Identification
`
`September 12, 2009
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`Recruitment Status, Study Status and Contacts/Locations
`
`December1, 2009
`
`Study Status, Contacts/Locations and Sponsor/Collaborators
`
`January 5,2011
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`Study Status
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`April 18,2011
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`Study Status and Study Design
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`May4,2011
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`Study Status
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`December 1, 2011
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`Recruitment Status, Study Status and Sponsor/Collaborators
`
`April 13, 2012
`
`Outcome Measures, References and Study Status
`
`Armsand Interventions, Outcome Measures, Study Status, More Information, Reported Adverse Events,
`Baseline Characteristics, Participant Flow, Elig bility, Study Description and Study Identification
`
`December20,2012
`
`December 17, 2012
`
`Reported Adverse Events, Outcome Measures, Baseline Characteristics, Participant Flow and Study Status
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`https://clinicaltrials.gov/ct2/history/NCT00509795?7A=8&B=9&C=merged#StudyPageTop
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`
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`1/7/2021
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`History of Changes for Study: NCT00509795
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`Comparison Format:
`
`@ Merged
`.
`.
`OSide-by-Side
`
`Compare v7 to v8
`
`Scroll up to access the controls
`
`Changes (Merged) for Study: NCT00509795
`March 3, 2009 (v8) -- April 28, 2009 (v9)
`
`
`Changesin: Outcome Measures, Arms and Interventions, Study Status, Eligibility, Conditions and Study Identification
`
`(_) Show only changed modules
`
`Study Identification
`
`Unique ProtocolID:
`
`VGFT-OD-0605
`
`BriefTitle:
`
`
`
`
`
`+-44E445 Vascular Endothelial Growth Factor(VEGF) Trap-Eye:Investigation of Efficacy and
`Wet Age-Related Macular Degeneration(AMD) (VIEW1)
`
`
`
`
`
`
`
`
`
`
`
`
`Safety in
`
`Official Title:
`
`A Randomized, Double Masked, Active Controlled PhaseIII Study of the Efficacy, Safety, and
`Tolerability of Repeated DosesofIntravitreal VEGF Trap in Subjects With Neovascular Age-Related
`Macular Degeneration
`
`Secondary IDs:
`
`Study Status
`
`Record Verification:
`
`Mareh2009 April 2009
`
`Overall Status:
`
`Recruiting
`
`Study Start:
`
`August 2007
`
`Primary Completion:
`
`Oeteber2040- December 2011 [Anticipated]
`
`Study Completion:
`
`danuary2042 December2011 [Anticipated]
`
`July 31, 2007
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`First Submitted:
`
`3/27
`
`
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`History of Changes for Study: NCT00509795
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`First Submitted that July 31, 2007
`Met QC Criteria:
`
`First Posted: August 1, 2007 [Estimate]
`
`Last Update Submitted that Mareh3-2999 April 28, 2009
`Met QCCriteria:
`
`Last Update Posted: Mareh-S April 29, 2009 [Estimate]
`
`Sponsor/Collaborators
`
`Sponsor: Regeneron Pharmaceuticals
`
`Responsible Party:
`
`Collaborators: Bayer
`
`Oversight
`
`U.S. FDA-regulated Drug:
`
`U.S. FDA-regulated Device:
`
`Data Monitoring: Yes
`
`Study Description
`
`Brief Summary: This studyis a phaseIII, double-masked, randomized, study of the efficacy and safety of VEGF Trap-
`Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will
`be randomizedin the US and Canada.
`
`Detailed Description:
`
`Conditions
`
`Conditions: NeevaseularAge-RetatedMacular Degeneration
`
`Keywords:
`
`Study Design
`
`Study Type: Interventional
`
`Primary Purpose: Treatment
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`Study Phase: Phase 3
`
`Interventional Study Model: Parallel Assignment
`
`Numberof Arms: 4
`
`Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
`
`Allocation: Randomized
`
`Enrollment: 1200 [Anticipated]
`
`ArmsandInterventions
`
`
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?7A=8&B=9&C=merged#StudyPageTop
`
`
`
`Experimental: 1
`
`Drug: VEGF Trap-Eye
`0.5 mg VEGFTrap-Eye administered every 4 weeks during
`the first year. Thereafter a dose may be administered as
`frequently as every 4 weeks, but no less frequently than
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`1/7/2021
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`History of Changes for Study: NCT00509795
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`every 12 weeks.
`
`
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?7A=8&B=9&C=merged#StudyPageTop
`
`
`
`Experimental: 2
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGFTrap-Eye administered every 4 weeks during
`the first year. Thereafter a dose may be administered as
`frequently as every 4 weeks, but no less frequently than
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`History of Changes for Study: NCT00509795
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`every 12 weeks.
`
`
`
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`History of Changes for Study: NCT00509795
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`Experimental: 3
`
`Drug: VEGF Trap-Eye
`2.0 mg VEGFTrap-Eye administered every 8 weeks
`(including one additional 2.0 mg dose at week 4) during the
`first year. Thereafter a dose may be administered as
`frequently as every 4 weeks, but no less frequently than
`every 12 weeks.
`
`but no less frequently than every 12 weeks.
`
`Drug—Cemparater Drug: ranibizumab
`Active Comparator: 4
`HESS0. mg
`administered every 4 weeks during thefirst year. Thereafter
`a dose may be administered as frequently as every 4 weeks,
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?7A=8&B=9&C=merged#StudyPageTop
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`1/7/2021
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`Outcome Measures
`
`Primary Outcome Measures:
`
`History of Changes for Study: NCT00509795
`
`1.
`
`
`ine- The proportion of subjects who maintain vision at Week
`52, where a subjectis classified as maintaining vision ifthe subject has lost fewerthan 15 letters on the ETDRS chart compared
`to baseline (i.e. prevention of moderate vision loss)
`Menthl Week 52
`
`Secondary Outcome Measures:
`
`2. Mean change from baseline in BCVA as measured by ETDRSletter score at Week 52
`Week 52
`
`3. The proportion of subjects whogain atleast 15 letters of vision at Week 52
`Week 52
`
`4. Mean change from baseline in total NEI VFQ-25 score at Week 52
`Week 52
`
`ine; Mean change from baseline in CNV
`area at Week 52
`
`
`
`as-dietatedbypreteestWeek 52
`
`Eligibility
`
`Minimum Age: 50 Years
`
`Maximum Age:
`
`Sex: All
`
`Gender Based:
`
`Accepts Healthy Volunteers: Yes No
`
`Criteria: Key Inclusion Criteria:
`
`1. Signed Informed Consent.
`2. Men and women2 50 years of age.
`3. Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal
`lesions that affect the fovea as evidenced by FAin the study eye.
`a
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`History of Changes for Study: NCT00509795
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`5. ETDRSbest-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
`6. Willing, committed, and able to return for ALLclinic visits and complete all study-related
`procedures.
`7. Able to read,(or, if unable to read due to visual impairment, be read to verbatim by the person
`administering the informed consentor a family member. See Appendix J.4) understand and
`willing to sign the informed consent form.
`
`Key ExclusionCriteria:
`
`1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except
`dietary supplements orvitamins.
`2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMDin
`the study eye, except dietary supplements or vitamins.
`3. Any prior treatment with anti-VEGF agents in the study eye.
`
`4. Peertreatrenttitani-boFageris-asfeto+s-
`
`5. Total lesion size > 12 disc areas (30.5 mmz2,including blood, scars and neovascularization) as
`assessed by FAin the study eye.
`6. Subretinal hemorrhagethatis either 50% or more ofthe total lesion area,orif the blood is under
`the fovea and is 1 or more disc areasin size in the study eye.(If the blood is underthe fovea,
`then the fovea must be surrounded 270 degrees byvisible CNV.)
`7. Scaror fibrosis, making up > 50% oftotal lesion in the study eye.
`8. Scar, fibrosis, or atrophy involving the center of the fovea.
`9. Presence ofretinal pigmentepithelial tears or rips involving the macula in the study eye.
`10. History of any vitreous hemorrhagewithin 4 weeksprior to Visit 1 in the study eye.
`11. Presenee-ofethereauses-ef CNY ineluding pathelegie myepia(sphereateauivate
`
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`10/27
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`
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`History of Changes for Study: NCT00509795
` angietd-stree eretdatrptt e- Presence of other
`
`causes of CNVin the study eye.
`12. History or clinical evidence of diabetic retinopathy, diabetic macular edemaor any other vascular
`disease affecting the retina,other than AMD,in either eye.
`13. Prior vitrectomyin the study eye.
`14. History of retinal detachmentor treatment or surgery for retinal detachmentin the study eye.
`15. Any history of macular hole of stage 2 and abovein the study eye.
`16. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, exceptlid
`surgery, which may not have taken place within 1 month of day 1, as long asits unlikely to
`interfere with the injection.
`
`Contacts/Locations
`
`Central Contact: Regeneron
`Telephone: 866-549-8439
`Email: VIEW1study@rtp.ppdi.com
`
`Study Officials: Avner Ingerman, MD
`Study Director
`Regeneron Pharmaceuticals
`
`Locations: United States, Alabama
`
`[Recruiting]
`Birmingham, Alabama, United States, 35205
`
`[Recruiting]
`Birmingham, Alabama, United States, 35223
`
`United States, Arizona
`
`[Recruiting]
`Phoenix, Arizona, United States, 85014
`
`[Recruiting]
`Phoenix, Arizona, United States, 85020
`
`[Recruiting]
`Tucson, Arizona, United States, 85704
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`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
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`11/27
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`1/7/2021
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`History of Changes for Study: NCT00509795
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`[Recruiting]
`Tucson, Arizona, United States, 85710
`
`United States, California
`
`[Recruiting]
`Beverly Hills, California, United States, 90211
`
`[Recruiting]
`Campbell, California, United States, 95008
`
`[Recruiting]
`Fullerton, California, United States, 92835
`
`[Terminated]
`Glendale, California, United States, 91203
`
`[Recruiting]
`Irvine, California, United States, 92697
`
`[Recruiting]
`La Jolla, California, United States, 92037
`
`[Recruiting]
`LomaLinda, California, United States, 92354
`
`[Withdrawn]
`Los Angeles, California, United States, 90033
`
`[Recruiting]
`Los Angeles, California, United States, 90048
`
`[Recruiting]
`Menlo Park, California, United States, 94025
`
`[Recruiting]
`Mountain View, California, United States, 94040
`
`[Recruiting]
`Oakland, California, United States, 94609
`
`[Recruiting]
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`12/27
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`
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`1/7/2021
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`History of Changes for Study: NCT00509795
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`Palm Springs, California, United States, 92262
`
`[Recruiting]
`Pasadena, California, United States, 91105
`
`[Withdrawn]
`Poway, California, United States, 92064
`
`[Recruiting]
`Sacramento, California, United States, 95819
`
`[Active, not recruiting]
`San Diego, California, United States, 92120
`
`[Terminated]
`San Francisco, California, United States, 94107
`
`[Recruiting]
`Santa Ana,California, United States, 92705
`
`[Recruiting]
`Torrance, California, United States, 90503
`
`[Withdrawn]
`Ventura, California, United States, 93003
`
`[Recruiting]
`Westlake Village, California, United States, 91361
`
`[Recruiting]
`Yorba Linda, California, United States, 92887
`
`United States, Colorado
`
`[Terminated]
`Aurora, Colorado, United States, 80045
`
`[Recruiting]
`Denver, Colorado, United States, 80205
`
`[Withdrawn]
`Denver, Colorado, United States, 80205
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`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
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`13/27
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`1/7/2021
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`History of Changes for Study: NCT00509795
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`[Withdrawn]
`Denver, Colorado, United States, 80230
`
`United States, Connecticut
`
`[Recruiting]
`Bridgeport, Connecticut, United States, 06606
`
`[Withdrawn]
`Hamden, Connecticut, United States, 06518
`
`[Active, not recruiting]
`New Haven, Connecticut, United States, 06510
`
`[Recruiting]
`New London, Connecticut, United States, 06320
`
`United States, Florida
`
`[Recruiting]
`Altamonte Springs, Florida, United States, 32701
`
`[Recruiting]
`Boynton Beach, Florida, United States, 33426
`
`[Recruiting]
`Fort Myers, Florida, United States, 33907
`
`[Withdrawn]
`Ft. Lauderdale, Florida, United States, 33351
`
`[Recruiting]
`Ft. Myers, Florida, United States, 33912
`
`[Withdrawn]
`Gainesville, Florida, United States, 32610
`
`[Recruiting]
`Jacksonville, Florida, United States, 32224
`
`[Withdrawn]
`Miami, Florida, United States, 33136
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`14/27
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`1/7/2021
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`History of Changes for Study: NCT00509795
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`[Recruiting]
`Miami, Florida, United States, 33143
`
`[Terminated]
`Mount Dora,Florida, United States, 32757
`
`[Recruiting]
`Orlando, Florida, United States, 32803
`
`[Recruiting]
`Orlando, Florida, United States, 32806
`
`[Recruiting]
`Oscala, Florida, United States, 34472
`
`[Recruiting]
`Palm Beach Gardens,Florida, United States, 33410
`
`[Recruiting]
`Pensacola, Florida, United States, 32503
`
`[Withdrawn]
`Sarasota, Florida, United States
`
`[Recruiting]
`Stuart, Florida, United States, 34994
`
`[Recruiting]
`Tampa,Florida, United States, 33612
`
`[Recruiting]
`Winter Haven, Florida, United States, 33880
`
`United States, Georgia
`
`[Recruiting]
`Augusta, Georgia, United States, 30909
`
`United States, Hawaii
`
`[Recruiting]
`Aiea, Hawaii, United States, 96701
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`15/27
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`1/7/2021
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`[Withdrawn]
`Honolulu, Hawaii, United States, 96813
`
`United States,Illinois
`
`[Recruiting]
`OakBrook,Illinois, United States, 60523
`
`United States, Indiana
`
`[Recruiting]
`Fort Wayne,Indiana, United States, 46804
`
`[Recruiting]
`Indianapolis, Indiana, United States, 46202
`
`[Terminated]
`Indianapolis, Indiana, United States, 46260
`
`[Recruiting]
`Indianapolis, Indiana, United States, 46280
`
`[Recruiting]
`NewAlbany, Indiana, United States, 47150
`
`United States, lowa
`
`[Recruiting]
`lowa City, lowa, United States, 52242-1091
`
`United States, Kansas
`
`[Recruiting]
`Wichita, Kansas, United States, 67214
`
`United States, Kentucky
`
`[Recruiting]
`Louisville, Kentucky, United States, 40202
`
`[Recruiting]
`Louisville, Kentucky, United States, 40207
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
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`16/27
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`1/7/2021
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`[Terminated]
`Paducah, Kentucky, United States, 42001
`
`United States, Louisiana
`
`[Recruiting]
`New Orleans, Louisiana, United States, 70115
`
`[Recruiting]
`New Orleans, Louisiana, United States, 70121
`
`[Terminated]
`Shreveport, Louisiana, United States, 71105
`
`United States, Maine
`
`[Recruiting]
`Bangor, Maine, United States, 04401
`
`[Recruiting]
`Portland, Maine, United States, 04102
`
`United States, Maryland
`
`[Recruiting]
`Baltimore, Maryland, United States, 21209
`
`[Recruiting]
`Baltimore, Maryland, United States, 21287
`
`[Recruiting]
`Chevy Chase, Maryland, United States, 20815
`
`[Recruiting]
`Hagerstown, Maryland, United States, 21740
`
`[Recruiting]
`Towson, Maryland, United States, 21204
`
`United States, Massachusetts
`
`[Withdrawn]
`Boston, Massachusetts, United States, 02111
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
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`17/27
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`[Recruiting]
`Boston, Massachusetts, United States, 02114
`
`[Recruiting]
`Boston, Massachusetts, United States, 02215
`
`[Withdrawn]
`Boston, Massachusetts, United States
`
`[Recruiting]
`Peabody, Massachusetts, United States, 01960
`
`United States, Michigan
`
`[Recruiting]
`AnnArbor, Michigan, United States, 48105
`
`[Recruiting]
`Battle Creek, Michigan, United States, 49015
`
`[Active, not recruiting]
`Detroit, Michigan, United States, 48202
`
`[Recruiting]
`Grand Rapids, Michigan, United States, 49525
`
`[Recruiting]
`Jackson, Michigan, United States, 49201
`
`[Recruiting]
`Royal Oak, Michigan, United States, 48073
`
`[Recruiting]
`Southfield, Michigan, United States, 48034
`
`[Withdrawn]
`West Bloomfield, Michigan, United States, 48322
`
`United States, Minnesota
`
`[Withdrawn]
`Edina, Minnesota, United States, 55435
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`18/27
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`1/7/2021
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`[Recruiting]
`Minneapolis, Minnesota, United States, 55404
`
`[Recruiting]
`Rochester, Minnesota, United States, 55905
`
`United States, Missouri
`
`[Recruiting]
`Florissant, Missouri, United States, 63031
`
`[Recruiting]
`KansasCity, Missouri, United States, 64108
`
`[Withdrawn]
`KansasCity, Missouri, United States, 64111
`
`[Recruiting]
`Springfield, Missouri, United States, 65804
`
`[Recruiting]
`St. Louis, Missouri, United States, 63110
`
`United States, Montana
`
`[Recruiting]
`Missoula, Montana, United States, 59801
`
`United States, Nebraska
`
`[Recruiting]
`Lincoln, Nebraska, United States, 68506
`
`[Withdrawn]
`Omaha, Nebraska, United States, 68131
`
`United States, Nevada
`
`[Recruiting]
`Las Vegas, Nevada, United States, 89144
`
`United States, New Jersey
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`19/27
`
`
`
`1/7/2021
`
`History of Changesfor Study: NCT00509795
`
`[Recruiting]
`Lawrenceville, New Jersey, United States, 08648
`
`[Terminated]
`New Brunswick, New Jersey, United States, 08901
`
`[Recruiting]
`Northfield, New Jersey, United States, 08225
`
`[Withdrawn]
`Teaneck, New Jersey, United States, 07666
`
`[Recruiting]
`TomsRiver, New Jersey, United States, 08753
`
`United States, New Mexico
`
`[Recruiting]
`Albuquerque, New Mexico, United States, 87106
`
`United States, New York
`
`[Recruiting]
`Albany, New York, United States, 12206
`
`[Recruiting]
`Brooklyn, New York, United States, 11223
`
`[Recruiting]
`Lynbrook, New York, United States, 11563
`
`[Recruiting]
`New York, New York, United States, 10003
`
`[Recruiting]
`New York, New York, United States, 10021
`
`[Recruiting]
`New York, New York, United States, 10032
`
`[Terminated]
`Poughkeepsie, New York, United States, 12601
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`20/27
`
`
`
`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Rochester, New York, United States, 14620
`
`[Recruiting]
`Rochester, New York, United States, 14642
`
`[Recruiting]
`Slingerlands, New York, United States, 12159
`
`[Recruiting]
`Syracuse, New York, United States, 13224
`
`United States, North Carolina
`
`[Recruiting]
`Asheville, North Carolina, United States, 28803
`
`[Recruiting]
`Charlotte, North Carolina, United States, 28210
`
`[Recruiting]
`Raleigh, North Carolina, United States, 27607
`
`[Terminated]
`Southern Pines, North Carolina, United States, 28387
`
`[Recruiting]
`Winston-Salem, North Carolina, United States, 27157
`
`United States, Ohio
`
`[Withdrawn]
`Cincinnati, Ohio, United States, 45202
`
`[Recruiting]
`Cincinnati, Ohio, United States, 45242
`
`[Terminated]
`Columbus, Ohio, United States, 43215
`
`[Terminated]
`Toledo, Ohio, United States, 43608
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`21/27
`
`
`
`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`United States, Oklahoma
`
`[Recruiting]
`OklahomaCity, Oklahoma, United States, 73104
`
`United States, Oregon
`
`[Recruiting]
`Ashland, Oregon, United States, 97520
`
`[Recruiting]
`Portland, Oregon, United States, 97210
`
`[Recruiting]
`Portland, Oregon, United States, 97227
`
`[Recruiting]
`Salem, Oregon, United States, 97302
`
`United States, Pennsylvania
`
`[Recruiting]
`Kingston, Pennsylvania, United States, 18704
`
`[Active, not recruiting]
`Philadelphia, Pennsylvania, United States, 19104
`
`[Recruiting]
`Philadelphia, Pennsylvania, United States, 19107
`
`[Recruiting]
`Philadelphia, Pennsylvania, United States, 19124
`
`[Recruiting]
`Pittsberg, Pennsylvania, United States, 15231
`
`[Recruiting]
`Pittsburgh, Pennsylvania, United States, 15212
`
`[Recruiting]
`Pittsburgh, Pennsylvania, United States, 15213
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`[Recruiting]
`
`22/27
`
`
`
`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`WestMifflin, Pennsylvania, United States, 15122
`
`[Withdrawn]
`Wyomissing, Pennsylvania, United States, 19610
`
`United States, Rhode Island
`
`[Recruiting]
`Providence, RhodeIsland, United States, 02903-4928
`
`United States, South Carolina
`
`[Recruiting]
`Charleston, South Carolina, United States, 29414
`
`[Recruiting]
`Columbia, South Carolina, United States, 29223
`
`[Recruiting]
`Greenville, South Carolina, United States, 29605
`
`[Recruiting]
`West Columbia, South Carolina, United States, 29169
`
`United States, South Dakota
`
`[Recruiting]
`Rapid City, South Dakota, United States, 57701
`
`United States, Tennessee
`
`[Terminated]
`Memphis, Tennessee, United States, 38119
`
`[Terminated]
`Memphis, Tennessee, United States, 38120
`
`[Recruiting]
`Nashville, Tennessee, United States, 37203
`
`United States, Texas
`
`[Recruiting]
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`23/27
`
`
`
`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`Abilene, Texas, United States, 79606
`
`[Recruiting]
`Austin, Texas, United States, 78705
`
`[Active, not recruiting]
`CorpusCristi, Texas, United States, 78413
`
`[Recruiting]
`Dallas, Texas, United States, 75390
`
`[Terminated]
`DeSoto, Texas, United States, 75115
`
`[Recruiting]
`Ft. Worth, Texas, United States, 76102
`
`[Recruiting]
`Ft. Worth, Texas, United States, 76104
`
`[Withdrawn]
`Galveston, Texas, United States, 77555
`
`[Recruiting]
`Houston, Texas, United States, 77030
`
`[Withdrawn]
`Houston, Texas, United States, 77030
`
`[Terminated]
`Houston, Texas, United States, 77030
`
`[Recruiting]
`McAllen, Texas, United States, 78503
`
`[Recruiting]
`Odessa, Texas, United States, 79761
`
`[Recruiting]
`San Antonio, Texas, United States, 78240
`
`United States, Utah
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`24/27
`
`
`
`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Salt Lake City, Utah, United States, 84107
`
`[Recruiting]
`Salt Lake City, Utah, United States, 84132
`
`United States, Vermont
`
`[Recruiting]
`Burlington, Vermont, United States, 05401
`
`United States, Virginia
`
`[Recruiting]
`Charlottesville, Virginia, United States, 22908
`
`[Recruiting]
`Fairfax, Virginia, United States, 22031
`
`[Recruiting]
`Richmond,Virginia, United States, 23221
`
`United States, Washington
`
`[Recruiting]
`Seattle, Washington, United States, 98104
`
`[Recruiting]
`Silverdale, Washington, United States, 98383
`
`United States, Wisconsin
`
`[Recruiting]
`Madison, Wisconsin, United States, 53715
`
`[Recruiting]
`Madison, Wisconsin, United States, 58705
`
`[Recruiting]
`Milwaukee, Wisconsin, United States, 53226
`
`Canada,Alberta
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`25/27
`
`
`
`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Calgary, Alberta, Canada, T3E 7MB
`
`Canada,British Columbia
`
`[Recruiting]
`Vancouver, British Columbia, Canada, V5Z 3N9
`
`[Recruiting]
`Victoria, British Columbia, Canada, V8V 1B3
`
`Canada, Nova Scotia
`
`[Recruiting]
`Halifax, Nova Scotia, Canada, B3H 2Y9
`
`Canada, Ontario
`
`[Recruiting]
`London, Ontario, Canada, N6A 4G5
`
`[Recruiting]
`Mississauga, Ontario, Canada, L4W 1W9
`
`[Recruiting]
`Ottawa, Ontario, Canada, K1H8L6
`
`[Recruiting]
`Toronto, Ontario, Canada, M4N3M5
`
`[Active, not recruiting]
`Toronto, Ontario, Canada, M5C 2T2
`
`Canada, Quebec
`
`[Recruiting]
`Montreal, Quebec, Canada, H1T 2M4
`
`[Recruiting]
`Montreal, Quebec, Canada, H3A 1A1
`
`Canada, Saskatchewan
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged#StudyPageTop
`
`26/27
`
`
`
`1/7/2021
`
`History of Changes for Study: NCT00509795
`
`[Recruiting]
`Regina, Saskatchewan, Canada, S4T 1A5
`
`IPDSharing
`
`References
`
`Plan to Share IPD:
`
`Citations:
`
`Links:
`
`Available IPD/Information:
`
`
`Scroll to the Studytop
`Scroll up to access the controls
`
`
`U.S. National Library of Medicine | U.S. NationalInstitutes of Health | U.S. Department of Health & Human Services
`
`https://clinicaltrials.gov/ct2/history/NCT00509795?7A=8&B=9&C=merged#StudyPageTop
`
`27/27
`
`
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