1/30/2020
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`History of Changes for Study: NCT00210548
`
`History of Changes for Study: NCT00210548
`
`A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating
`Subjects With Schizophrenia
`
`Latest version (submitted June 6, 2011) on ClinicalTrials.gov
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`currently being viewed.
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`Study Record Versions
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`September 13, 2005 None (earliest Version on record)
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`October 19, 2005 Contacts/Locations, Eligibility and Study Status
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`December 2, 2005 Contacts/Locations and Study Status
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`January 27, 2006 Contacts/Locations and Study Status
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`March 3, 2006 Contacts/Locations, Study Status and Eligibility
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`March 31, 2006 Contacts/Locations and Study Status
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`April 28, 2006 Study Status
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`May 26, 2006 Contacts/Locations and Study Status
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`July 3, 2006 Study Status and Contacts/Locations
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`September 1, 2006 Contacts/Locations and Study Status
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`October 6, 2006 Study Status, Contacts/Locations and Oversight
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`March 12, 2007 Study Status
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`https://clinicaltrials.gov/ct2/history/NCT00210548?V_11=View#StudyPageTop
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`History of Changes for Study: NCT00210548
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`Version
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`Submitted Date
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`April 1, 2007 Recruitment Status, Contacts/Locations and Study Status
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`October 11, 2007 Recruitment Status, Study Status and Contacts/Locations
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`August 27, 2009 Study Status, Study Design, References, Contacts/Locations, Eligibility and Study
`Description
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`November 19, 2009 Study Status and Study Design
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`April 26, 2010 Study Status
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`June 6, 2011 References and Study Status
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`Compare
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`Study NCT00210548
`Submitted Date: October 6, 2006 (v11)
`
`Study Identification
`Unique Protocol ID: CR002353
`Brief Title: A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate
`in Treating Subjects With Schizophrenia
`Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response
`Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50 mg eq., 100 mg eq.,
`and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia
`
`Secondary IDs:
`
`Study Status
`
`Record Verification: October 2006
`Overall Status: Recruiting
`Study Start: April 2005
`Primary Completion:
`Study Completion:
`
`First Submitted: September 13, 2005
`First Submitted that
`September 13, 2005
`Met QC Criteria:
`First Posted: September 21, 2005 [Estimate]
`
`October 6, 2006
`
`Last Update Submitted that
`Met QC Criteria:
`Last Update Posted: October 11, 2006 [Estimate]
`Sponsor/Collaborators
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`https://clinicaltrials.gov/ct2/history/NCT00210548?V_11=View#StudyPageTop
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`History of Changes for Study: NCT00210548
`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: The purpose of this study is to evaluate the effectiveness and safety of 3 doses of
`paliperidone palmitate in treating subjects with schizophrenia.
`Detailed Description: This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter,
`dose-response study of patients who have a Diagnostic and Statistical Manual of
`Mental Disorders, 4th edition (DSM IV) diagnosis of schizophrenia. The duration of the
`study is approximately 14 weeks, including a screening period of 1 week and a 13-
`week double-blind treatment period. Efficacy and safety will be evaluated periodically
`throughout the study. Samples for pharmacokinetic evaluation will be collected at
`designated time points, and a blood sample will be collected at baseline (before the
`start of double-blind treatment) for an optional pharmacogenomics (genetics) analysis.
`The hypothesis is that the 3 fixed doses of paliperidone are each more efficacious
`than placebo in treating subjects with schizophrenia. The effectiveness is measured
`primarily by the change in the Positive and Negative Syndrome Scale for
`Schizophrenia (PANSS), and secondarily, by the investigator's Clinical Global
`Impression of Severity (CGI-S) and by the investigator's evaluation of the patient on a
`Personal and Social Performance (PSP) Scale.
`
`Four injections of paliperidone palmitate 50, 100, or 150 milligrams equivalent
`administered in the gluteal muscle (buttocks). Injections will be given on Days 1, 8, 36,
`and 64 of the double-blind treatment period of the study.
`
`Conditions
`
`Conditions: Schizophrenia
`Keywords: dementia praecox
`schizophrenia
`paliperidone palmitate
`antipsychotic agents
`PANSS.
`intramuscular injection
`mental disorders
`
`Study Design
`
`Study Type: Interventional
`Primary Purpose: Treatment
`Study Phase: Phase 3
`Interventional Study Model: Parallel Assignment
`Number of Arms:
`Masking: Double (masked roles unspecified)
`
`https://clinicaltrials.gov/ct2/history/NCT00210548?V_11=View#StudyPageTop
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`History of Changes for Study: NCT00210548
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`Allocation: Randomized
`Enrollment: 376
`Arms and Interventions
`Intervention Details:
`Drug: paliperidone palmitate
`Outcome Measures
`Primary Outcome Measures:
`1. The change in the total score of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) from
`the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
`Secondary Outcome Measures:
`2. The investigator's Clinical Global Impression of the Severity (CGI-S) of schizophrenia and rating of mental
`function on a Personal and Social Performance Scale (PSP). Evaluations of adverse events, laboratory tests,
`and other measures of drug safety.
`
`Eligibility
`
`Minimum Age: 18 Years
`Maximum Age:
`Sex: All
`Gender Based:
`Accepts Healthy Volunteers: No
`Criteria: Inclusion Criteria:
`
`A DSM-IV diagnosis of schizophrenia (disorganized, catatonic, paranoid,
`residual, or undifferentiated type) for at least 1 year before the screening
`evaluation
`a total PANSS score of 70 to 120 at screening and baseline (pre-treatment)
`evaluations
`a body mass index (BMI [weight (kilograms)]/[height (meters)]²) of more than
`17.0 kg/m²
`
`Exclusion Criteria:
`
`A primary active DSM-IV Axis I diagnosis other than schizophrenia
`a decrease of 25% or more in the total PANSS score between screening and
`baseline evaluations
`a DSM-IV diagnosis of active substance dependence within 3 months of
`screening evaluation
`a history of treatment resistance as defined by failure to respond to 2 adequate
`trials of different antipsychotic medications
`A woman who is pregnant, breast-feeding, or planning to become pregnant
`during the study period
`
`Contacts/Locations
`Central Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If
`you still have questions:
`Email: info1@veritasmedicine.com
`Study Officials: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
`
`https://clinicaltrials.gov/ct2/history/NCT00210548?V_11=View#StudyPageTop
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`History of Changes for Study: NCT00210548
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`Study Director
`Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`Locations: United States, California
`Collaborative NeuroScience Network
`[Recruiting]
`Garden Grove, California, United States, 92845
`Contact: David Walling 714-799-7799
`Principal Investigator: David Walling
`[Active, not recruiting]
`Pasadena, California, United States, 91107
`[Active, not recruiting]
`San Diego, California, United States, 92123
`United States, Florida
`[Active, not recruiting]
`North Miami, Florida, United States, 33161
`United States, Illinois
`[Active, not recruiting]
`Chicago, Illinois, United States, 60640
`[Active, not recruiting]
`Hoffman Estate, Illinois, United States, 60194
`United States, Indiana
`[Active, not recruiting]
`Indianapolis, Indiana, United States, 46222
`United States, Kansas
`[Active, not recruiting]
`Wichita, Kansas, United States, 67214
`United States, Louisiana
`[Active, not recruiting]
`Lake Charles, Louisiana, United States, 70601
`United States, Maryland
`[Active, not recruiting]
`Towson, Maryland, United States, 21286
`United States, Mississippi
`[Active, not recruiting]
`Flowood, Mississippi, United States, 39232
`United States, New Jersey
`[Active, not recruiting]
`Clementon, New Jersey, United States, 08021
`United States, New York
`[Active, not recruiting]
`Holliswood, New York, United States, 11423
`[Active, not recruiting]
`Staten Island, New York, United States, 10305
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`History of Changes for Study: NCT00210548
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`United States, Ohio
`[Active, not recruiting]
`Chagrin Falls, Ohio, United States, 44022
`United States, Oklahoma
`[Active, not recruiting]
`Oklahoma City, Oklahoma, United States, 73120
`United States, Pennsylvania
`[Active, not recruiting]
`Norristown, Pennsylvania, United States, 19401
`[Active, not recruiting]
`Philadelphia, Pennsylvania, United States, 19139
`United States, Tennessee
`[Active, not recruiting]
`Memphis, Tennessee, United States, 38105
`United States, Texas
`[Active, not recruiting]
`Austin, Texas, United States, 78729
`[Active, not recruiting]
`Houston, Texas, United States, 77057
`[Active, not recruiting]
`Irving, Texas, United States, 75062
`United States, Virginia
`[Active, not recruiting]
`Portsmouth, Virginia, United States, 23703
`Korea, Republic of
`[Active, not recruiting]
`Dae-Gu, Korea, Republic of, 700-721
`[Active, not recruiting]
`Pusan, Korea, Republic of, 602-739
`[Active, not recruiting]
`Seoul, Korea, Republic of, 143-711
`Malaysia
`[Active, not recruiting]
`Ipoh, Malaysia, 31650
`[Active, not recruiting]
`Kota Bahru, Malaysia, 15586
`[Active, not recruiting]
`Kuala Lumpur, Malaysia, 59100
`Taiwan
`[Active, not recruiting]
`Hua Lian, Taiwan, 981
`[Active, not recruiting]
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`History of Changes for Study: NCT00210548
`Kaohsiung County, Taiwan, 83342
`[Active, not recruiting]
`Taipei, Taiwan, 100
`[Active, not recruiting]
`Taipei, Taiwan, 110
`Ukraine
`[Active, not recruiting]
`Dnepropetrovsk, Ukraine, 49616
`[Active, not recruiting]
`Kharkov, Ukraine, 61068
`[Active, not recruiting]
`Simferopol, Ukraine, 95006
`
`IPDSharing
`
`References
`
`Plan to Share IPD:
`
`Citations: Gopal S, Hough DW, Xu H, Lull JM, Gassmann-Mayer C, Remmerie BM, Eerdekens
`MH, Brown DW. Efficacy and safety of paliperidone palmitate in adult patients with
`acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled,
`dose-response study. Int Clin Psychopharmacol. 2010 Sep;25(5):247-56. doi:
`10.1097/YIC.0b013e32833948fa. PubMed 20389255
`
`Links:
`Available IPD/Information:
`
`Scroll up to access the controls
`
`Scroll to the Study top
`
`U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
`
`https://clinicaltrials.gov/ct2/history/NCT00210548?V_11=View#StudyPageTop
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