1/30/2020
`
`History of Changes for Study: NCT00101634
`
`US. National Library of Medicine
`
`ClinicalTria/s.g0v archive
`
`History of Changes for Study: NCT00101634
`
`Safety and Efficacy of an Anti-Psychotic Versus Placebo in Subjects With Schizophrenia
`
`Latest version (submitted June 6, 2011) on CIinigalTrials.go_v
`
`A study version is represented by a row in the table.
`
`Select two study versions to compare. One each from columns A and B.
`
`Choose either 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.
`
`Click "Compare" to do the comparison and show the differences.
`
`Select a version's Submitted Date link to see a rendering of the study for that version.
`
`The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version
`currently being viewed.
`
`Hover over the "Recruitment Status" to see how the study‘s recruitment status changed.
`
`Study edits or deletions are displayed in red.
`
`Study additions are displayed in green.
`
`Study Record Versions
`
`June 23,2_005
`
`None (earliest Version on record)
`
`flglfiLQEZQSLQ
`
`Contacts/Locations, Study Design and Study Status
`
`SEWJM
`
`Contacts/Locations and Study Status
`
`Noyember 23, 2Q05
`
`Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Study
`Design
`
`Januamzhzml
`
`Recruitment Status, Study Status and Contacts/Locations
`
`mwfi._2ooe
`
`Study Status and Study Identification
`
`Study Status
`
`Ecumenism
`
`Study Status, Contacts/Locations. Outcome Measures, Study Description, Study
`Identification, Eligibility, Arms and Interventions, Study Design, Conditions and
`Oversight
`
`A_ug_t_us27109.9
`
`Study Design, Study Status, References, Contacts/Locations, Eligibility and Study
`Description
`
`MMJQQQ
`
`Study Status
`
`April 26. 201 Q
`
`11
`
`12
`
`w1m Study Status and Study Design
`
`,Igng Q, 2911
`
`“My56?}? §n§‘§‘e”fi (1PR202000440) bx 1033, p. 001
`httos://clinicaltrials.aov/ct2/historv/NCTOO101634?V 3=View#Stuvaaquop
`
`1/7
`
`

`

`History of Changes for Study: NCT00101634
`1/30/2020
`
`
`Com are
`p
`
`Com arison Format'
`p
`‘
`'
`
`. Merged
`Side-by—Side
`
`
`
`Scroll up to access the mntrols
`
`
`Study NCT00101634
`
`Submitted Date: September 21, 2005 (v3)
`
`Study Identification
`
`Unique Protocol ID: R092670-PSY-3004
`
`Brief Title: Safety and Efficacy of an Anti-Psychotic Versus Placebo in Subjects \Mth
`
`Schizophrenia
`
`Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response
`
`Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq, 50 mg eq, and
`
`100 mg eq) of Paliperidone Palmitate in Subjects With Schizophrenia
`
`Secondary IDs:
`
`Study Status
`
`Record Verification: September 2005
`
`Overall Status: Recruiting
`
`Study Start:
`
`Primary Completion:
`
`Study Completion:
`
`First Submitted: January 12, 2005
`
`First Submitted that January 12, 2005
`Met QC Criteria:
`
`First Posted: January 13, 2005 [Estimate]
`
`Last Update Submitted that September 21, 2005
`Met QC Criteria:
`
`Last Update Posted: September 23, 2005 [Estimate]
`
`Sponsor/Collaborators
`
`Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`
`Responsible Party:
`
`Collaborators:
`
`Oversight
`
`U.S. FDA-regulated Drug:
`
`U.S. FDA-regulated Device:
`
`Data Monitoring:
`
`Study Description
`
`Brief Summary: This study is to determine the efficacy (how well the drug works), safety, and side
`Mylan V. Janssen (IPR2020-00440) Ex. 1033, p. 002
`httpszllclinicaltrialsgov/ct2/history/NCT00101634W_3=View#StudyPageTop
`
`2/7
`
`

`

`1/30/2020
`
`History of Changes for Study: NCT00101634
`
`effects of the study medication compared to placebo in the treatment of the symptoms
`of schizophrenia in adults.
`
`Detailed Description:
`
`Conditions
`
`Study Design
`
`Conditions:
`
`Schizophrenia
`
`Keywords:
`
`Schizophrenia
`
`psychosis
`
`Study Type:
`
`Interventional
`
`Primary Purpose:
`
`Treatment
`
`Study Phase:
`
`Phase 3
`
`Interventional Study Model:
`
`Parallel Assignment
`
`Number of Arms:
`
`Masking:
`
`Double (masked roles unspecified)
`
`Allocation:
`
`Randomized
`
`Enrollment:
`
`Arms and interventions
`
`intervention Details:
`
`Drug: R092670/Placebo
`
`Outcome Measures
`
`Eligibility
`
`Minimum Age:
`
`18 Years
`
`Maximum Age:
`
`Sex:
`
`All
`
`Gender Based:
`
`Accepts Healthy Volunteers:
`
`NO
`
`Criteria:
`
`Inclusion Criteria:
`
`0 Adults aged 18 years and older
`
`- Met diagnostic criteria for schizophrenia according to DSM-IV for at least 1 year
`before screening
`
`0 Body mass index (BMl) of >15.0 kg/mz
`. Women of childbearing potential must have a negative urine pregnancy before
`
`receiving a dose of study drug
`. Must be healthy based on medical exam, laboratory tests, and
`electrocardiogram
`
`Exclusion Criteria:
`
`c Subjects who are unable to provide their own consent or who have been
`involuntarily committed to psychiatric hospitalization
`- Acute or unstable medical conditions
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1033, p. 003
`https://c|inicaltrials.gov/th/history/NCTOO101634?V_3=View#StudyPageTop
`
`3/7
`
`

`

`1/30/2020
`
`History of Changes for Study: NCT00101634
`. Significant risk of suicidal, homicidal or violent ideation or behavior as clinically
`assessed by the investigator
`0 Woman who is pregnant, breast-feeding, or planning to become pregnant during
`
`the study period
`
`. Primary active DSM—IV Axis I diagnosis other than schizophrenia
`
`ContactsILocations
`
`Locations: United States, California
`
`[Recruiting]
`Cerritos, California, United States, 90814
`
`Contact: Study Contact 562—402-3102
`
`[Recruiting]
`La Mesa, California, United States, 91942
`
`Contact: Study Contact 619-667-4568
`
`[Recruiting]
`
`Los Angeles, California, United States, 90011
`
`Contact: Study Contact 714-224-8262
`
`[Recruiting]
`
`Oceanside, California, United States, 92056
`
`Contact: Study Contact 760-631-3056
`
`[Recruiting]
`San Marino, California, United States, 91108
`
`Contact: Study Contact 6264058808
`
`[Recruiting]
`Santa Ana, California, United States, 92705
`
`Contact: Study Contact 714-547-4100
`
`United States, District of Columbia
`
`[Recruiting]
`
`Washington, District of Columbia, United States, 20016
`
`Contact: Study Contact 202-885-5666
`
`United States, Florida
`
`[Recruiting]
`Jacksonville, Florida, United States, 32256
`
`Contact: Study Contact 904-673-2998
`
`[Recruiting]
`
`Leesburg, Florida, United States, 34748
`
`Contact: Study Conact 352-315-7817
`
`[Recruiting]
`
`South Miami, Florida, United States, 33143
`
`Contact: Study Contact 305-669-6166
`
`United States, Georgia
`
`[Recruiting]
`
`Atlanta, Georgia, United States, 30308
`
`Contact: Study Contact 404-881-5800
`
`[Recruiting]
`
`Mylan V. Janssen (IPR2020-00440) Ex. 1033, p. 004
`httpszllclinicaltrials.gov/ct2/history/NCT00101634?V_3=View#StudyPageTop
`
`4/7
`
`

`

`1/30/2020
`
`History of Changes for Study: NCT00101634
`
`Augusta, Georgia, United States, 30912
`Contact: Study Contact 706-721 -7968
`
`United States, Illinois
`
`[Recruiting]
`Oak Brook, Illinois, United States, 60523
`
`Contact: Study Contact 6309281000
`
`United States, Louisiana
`
`[Recruiting]
`Shreveport, Louisiana, United States, 71101
`Contact: Study Contact 318-227-9600
`
`United States, New Jersey
`
`[Recruiting]
`
`Kenilworth, New Jersey, United States, 07033
`
`Contact: Study Contact 908-241-1022
`
`United States, New Mexico
`
`[Recruiting]
`Albuquerque, New Mexico, United States, 87111
`
`Contact: Study Contact 505-848-3773
`
`United States, New York
`
`[Recruiting]
`Lawrence, New York, United States, 11559
`
`Contact: Study Contact 516-295-7230
`
`United States, Ohio
`
`[Recruiting]
`Cincinnati, Ohio, United States, 45267-0559
`
`Contact: Study Contact 513-558-4615
`
`United States, Oklahoma
`
`[Terminated]
`Oklahoma City, Oklahoma, United States, 73118
`
`United States, Texas
`
`[Recruiting]
`Desoto, Texas, United States, 75115
`
`Contact: Study Contact 972-283-6242
`
`United States, Virginia
`
`[Recruiting]
`Falls Church, Virginia, United States, 22044
`
`Contact: Study Contact 7035316179
`
`United States, Wisconsin
`
`[Recruiting]
`Milwaukee, Vlfisconsin, United States, 53295
`
`Contact: Study Contact 4143842000
`
`Bulgaria
`
`[Recruiting]
`
`Mylan v. Janssen (IPR2020-00440) EX. 1033, p. 005
`https://clinicaltria|s.gov/ct2/history/NCT00101634?V_3=View#StudyPageTop
`
`5/7
`
`

`

`1/30/2020
`
`History of Changes for Study: NCT00101634
`
`Burgas, Bulgaria, 8000
`Contact: Study Contact 35956812350
`
`[Recruiting]
`Radnevo, Bulgaria, 6260
`
`Contact: Study Contact 3592981782586
`
`[Recruiting]
`
`Sofia, Bulgaria, 1000
`
`Contact: Study Contact 35929816061
`
`Mexico, 64960
`
`[Not yet recruiting]
`
`Monterrey, 64960, Mexico
`
`Contact: Study Contact 518111995510
`
`Mexico
`
`[Not yet recruiting]
`Monterrey, Mexico, 64960
`
`Contact: Study Contact 528183523051
`
`[Not yet recruiting]
`Puebla, Mexico, 72573
`
`Contact: Study Contact 522222161540
`
`[Not yet recruiting]
`
`Tampico, Mexico, 89130
`
`Contact: Study Contact 528332131862
`
`Romania
`
`[Recruiting]
`Brasov, Romania, 500124
`
`Contact: Study Contact 40726112087
`
`[Recruiting]
`Bucuresti, Romania, 041914
`
`Contact: Study Contact 40726112087
`
`[Recruiting]
`Jud TIMIS, Romania, 307235
`
`Contact: Study Contact 40256394442
`
`[Recruiting]
`
`Tg. MURES, Romania, 540139
`
`Contact: Study Contact 40744512724
`
`Russian Federation
`
`[Recruiting]
`
`Kazan, Russian Federation, 420012
`
`Contact: Study Contact 78432360942
`
`[Recruiting]
`Lenigradsky Region, Russian Federation, 188357
`Contact: Study Contact 78127156441
`
`[Recruiting]
`Moscow, Russian Federation, 113152
`Contact: Study Contact 70959528331
`Mylan V. Janssen (IPR2020-00440) Ex. 1033, p. 006
`httpszllclinicaltrials.govlct2/history/NCTOO101634?V_3=\fiew#StudyPageTop
`
`

`

`1/30/2020
`
`History of Changes for Study: NCT00101634
`
`[Recruiting]
`Moscow, Russian Federation, 115522
`Contact: Study Contact 70951165183
`
`[Recruiting]
`Nizny Novgorod, Russian Federation, 603155
`Contact: Study Contact 78312192496
`
`[Recruiting]
`Saratov, Russian Federation, 410028
`
`Contact: Study Contact 78452224905
`
`[Recruiting]
`
`St Petersburg, Russian Federation, 193019
`
`Contact: Study Contact 78125677217
`
`[Recruiting]
`
`St Petersburg, Russian Federation, 78123018567
`
`Contact: Study Contact 78123018567
`
`South Africa
`
`[Not yet recruiting]
`Bellville, South Africa, 7530
`
`Contact: Study Contact 4210219404463
`
`[Recruiting]
`
`Centurion, South Africa
`
`Contact: Study Contact 4210126640222
`
`[Not yet recruiting]
`
`Eastern Cape, South Africa, 5100
`
`Contact: Study Contact 4210475022233
`
`[Recruiting]
`
`Johannesburg, South Africa
`Contact: Study Contact 4210125214143
`
`lPDSharing
`
`References
`
`Plan to Share IPD:
`
`Citations:
`
`Links:
`
`Available lPD/lnformation:
`
`WWW
`WW
`
`I [1.8. National Institutes of Health lmnmmmueafllmanmbes
`
`Mylan V. Janssen (IPR2020-00440) Ex. 1033, p. 007
`httpszllclinicaltrials.gov/th/history/NCT00101634?V_3=\filew#StudyPageTop
`
`7/7
`
`