1/30/2020
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`History of Changes for Study: NCT00210717
`
`History of Changes for Study: NCT00210717
`
`A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone
`Palmitate and Risperidone in Treating Patients With Schizophrenia
`
`Latest version (submitted June 6, 2011) on ClinicalTrials.gov
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`Study Record Versions
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`B
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`Submitted Date
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`Changes
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`September 13, 2005 None (earliest Version on record)
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`October 7, 2005 Contacts/Locations, Eligibility and Study Status
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`November 10, 2005 Contacts/Locations 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 Recruitment Status, Study Status and Contacts/Locations
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`October 11, 2007 Recruitment Status, Study Status and Oversight
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`June 29, 2009 Study Status, References, Contacts/Locations, Eligibility, Study Design and Study
`Description
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`https://clinicaltrials.gov/ct2/history/NCT00210717?V_10=View#StudyPageTop
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`1/5
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`Mylan v. Janssen (IPR2020-00440) Ex. 1034, p. 001
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`1/30/2020
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`History of Changes for Study: NCT00210717
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`Version
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`Submitted Date
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`July 8, 2009 References and Study Status
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`August 28, 2009 Study Status, References 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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`Study NCT00210717
`Submitted Date: July 3, 2006 (v10)
`
`Study Identification
`Unique Protocol ID: CR004195
`Brief Title: A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of
`Paliperidone Palmitate and Risperidone in Treating Patients With Schizophrenia
`Official Title: A Randomized, Double-Blind, Parallel Group, Comparative Study of Flexibly Dosed
`Paliperidone Palmitate (25, 50, 75, or 100 mg eq.) Administered Every 4 Weeks and
`Flexibly Dosed RISPERDAL CONSTA (25, 37.5, or 50 mg) Administered Every 2
`Weeks in Subjects With Schizophrenia
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`Secondary IDs:
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`Study Status
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`Record Verification: June 2006
`Overall Status: Active, not recruiting
`Study Start: February 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]
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`July 3, 2006
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`Last Update Submitted that
`Met QC Criteria:
`Last Update Posted: July 4, 2006 [Estimate]
`Sponsor/Collaborators
`
`Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`Responsible Party:
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`https://clinicaltrials.gov/ct2/history/NCT00210717?V_10=View#StudyPageTop
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`2/5
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`Mylan v. Janssen (IPR2020-00440) Ex. 1034, p. 002
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`1/30/2020
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`History of Changes for Study: NCT00210717
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`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 compare the effectiveness and safety over 1 year of
`treatment of intramuscular injections of paliperidone palmitate and long-acting
`risperidone in patients with schizophrenia.
`Detailed Description: Paliperidone palmitate is being developed as a long-acting intramuscular injectable
`formulation for the treatment of schizophrenia. Many patients with schizophrenia
`achieve symptom stability with the available oral antipsychotic medications; however, it
`is estimated that up to 75% have difficulty adhering to a daily oral treatment regimen.
`Long-acting injectable formulations may make compliance with the treatment regimen
`easier by eliminating the need for daily medication. An injectable formulation of
`risperidone is widely used in the treatment of schizophrenia and has been well
`tolerated by patients with chronic schizophrenia at the recommended dosage of 25 to
`50 milligrams every 2 weeks. The present study is designed to evaluate the
`comparability of paliperidone palmitate and long-acting injectable risperidone over 1
`year of treatment. This is a randomized, double-blind, active-controlled, parallel-group,
`multicenter comparative study in patients with schizophrenia. The study comprises a
`screening period of up to 1 week (including periods for washout of psychotropic
`medications and, if necessary, an oral tolerability test) and a 53-week double-blind
`treatment period. In the double-blind treatment period, patients will be randomly
`assigned in equal numbers to receive treatment with either (1) flexibly dosed
`paliperidone palmitate administered every 4 weeks or (2) flexibly dosed long-acting
`risperidone administered every 2 weeks. Drug effectiveness 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 the double-blind treatment period) or at any subsequent
`visit for an optional pharmacogenomic (genetic) analysis. The study hypothesis is that
`paliperidone palmitate will be as effective as long-acting risperidone in the treatment of
`patients with schizophrenia.
`
`Paliperidone palmitate (25, 50, 75, or 100 milligrams (mg) equivalent) every 4 weeks,
`or long-acting risperidone 25, 37.5, or 50 mg every 2 weeks of double-blind treatment
`period, injected into the gluteal muscle (buttocks). Oral risperidone (1-6 mg) first 4
`weeks of double-blind period
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`Conditions
`
`Conditions: Schizophrenia
`Keywords: paliperidone palmitate
`antipsychotic agents
`dementia praecox
`risperidone
`intramuscular injection
`mental disorders
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`https://clinicaltrials.gov/ct2/history/NCT00210717?V_10=View#StudyPageTop
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`3/5
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`Mylan v. Janssen (IPR2020-00440) Ex. 1034, p. 003
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`1/30/2020
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`History of Changes for Study: NCT00210717
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`schizophrenia
`PANSS
`
`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)
`Allocation: Randomized
`Enrollment: 700
`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 (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.
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`Eligibility
`
`Minimum Age: 18 Years
`Maximum Age:
`Sex: All
`Gender Based:
`Accepts Healthy Volunteers: No
`Criteria: Inclusion Criteria:
`
`A diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or
`undifferentiated types) according to the Diagnostic and Statistical Manual of
`Mental Disorders, 4th edition (DSM IV) for at least 1 year before the screening
`evaluation
`a total PANSS score of 60 to 120 at screening and baseline (pre-treatment)
`evaluations
`A body mass index (BMI [weight (kilograms)]/[height (meters)]²) of at least 15.0
`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
`
`https://clinicaltrials.gov/ct2/history/NCT00210717?V_10=View#StudyPageTop
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`4/5
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`Mylan v. Janssen (IPR2020-00440) Ex. 1034, p. 004
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`1/30/2020
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`History of Changes for Study: NCT00210717
`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
`Study Officials: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
`Study Director
`Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`
`Locations:
`
`Plan to Share IPD:
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`IPDSharing
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`References
`
`Citations: Fleischhacker WW, Gopal S, Lane R, Gassmann-Mayer C, Lim P, Hough D,
`Remmerie B, Eerdekens M. A randomized trial of paliperidone palmitate and
`risperidone long-acting injectable in schizophrenia. Int J Neuropsychopharmacol. 2012
`Feb;15(1):107-18. doi: 10.1017/S1461145711001076. Epub 2011 Jul 22. Erratum in:
`Int J Neuropsychopharmacol. 2012 Feb;15(1):119. Dosage error in article text.
`PubMed 21777507
`
`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/NCT00210717?V_10=View#StudyPageTop
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`5/5
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1034, p. 005
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