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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02507687
Registration number
NCT02507687
Ethics application status
Date submitted
22/07/2015
Date registered
24/07/2015
Titles & IDs
Public title
Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension
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Scientific title
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
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Secondary ID [1]
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2015-002131-18
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Secondary ID [2]
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192024-093
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glaucoma, Open-Angle
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Ocular Hypertension
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Bimatoprost SR
Treatment: Drugs - Sham Bimatoprost SR
Treatment: Surgery - Selective Laser Trabeculoplasty
Treatment: Surgery - Sham Selective Laser Trabeculoplasty
Experimental: Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye) - Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations.
Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).
Experimental: Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye) - Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations.
Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).
Experimental: Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye) - Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations.
Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met.
Experimental: Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye) - Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye:
Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations.
Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations.
Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met.
Treatment: Drugs: Bimatoprost SR
Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.
Treatment: Drugs: Sham Bimatoprost SR
Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.
Treatment: Surgery: Selective Laser Trabeculoplasty
SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye.
An ophthalmologist performed 360 degrees of SLT using a standardized method.
Treatment: Surgery: Sham Selective Laser Trabeculoplasty
Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Intraocular Pressure at Week 4
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Assessment method [1]
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Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. A mixed-effects model with repeated measures (MMRM) was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
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Timepoint [1]
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Baseline and Week 4
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Primary outcome [2]
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Change From Baseline in Intraocular Pressure at Week 12
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Assessment method [2]
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Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
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Timepoint [2]
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Baseline and Week 12
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Primary outcome [3]
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Change From Baseline in Intraocular Pressure at Week 24
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Assessment method [3]
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Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
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Timepoint [3]
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Baseline and Week 24
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Secondary outcome [1]
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Time to Initial Use of Non-study IOP-lowering Treatment
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Assessment method [1]
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The time from the date of initial treatment to the date date of first use of non-study IOP-lowering treatment (rescue) was analyzed using the Kaplan-Meier method.
If a participant did not use any non-study IOP-lowering treatment in an eye, then the event (initial use of non-study IOP-lowering treatment) time was censored at the study exit date or the last visit date if the study exit date was not available.
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Timepoint [1]
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From first administration of study treatment to the end of study; overall median follow-up time of 728 days.
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Secondary outcome [2]
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Percentage of Eyes Achieving = 20% Reduction in IOP From Baseline Regardless of Cycle
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Assessment method [2]
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Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer.
For by-cycle analyses, cycle number refers to the administration cycle for bimatoprost SR, or sham bimatoprost SR administration in SLT-treated eyes. For SLT-treated eyes cycle number does not refer to SLT administrations, because SLT was only performed once (Day 1). The Day/Week number refers to the number of days/weeks after bimatoprost SR/sham bimatoprost SR administration.
IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
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Timepoint [2]
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Baseline, Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52, Months 13, 14, 15, 16, 18, 20, 22, 24
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Secondary outcome [3]
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Change From Baseline in IOP at Weeks 8, 15, and 20
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Assessment method [3]
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IOP was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
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Timepoint [3]
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Baseline and Weeks 8, 15, and 20
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Eligibility
Key inclusion criteria
* Diagnosis of either open-angle glaucoma or ocular hypertension in each eye that require IOP lowering treatment.
* In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
* In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with SLT monotherapy.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of previous laser trabeculoplasty
* History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc) or history of phakic IOL insertion for refractive error correction
* Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment
* Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/05/2023
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Sample size
Target
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Accrual to date
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Final
240
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Queensland Eye Institute /ID# 236074 - South Brisbane
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Recruitment hospital [2]
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Eye Surgery Associates /ID# 235872 - East Melbourne
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Recruitment hospital [3]
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Melbourne Eye Specialists /ID# 234614 - Fitzroy
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Waverley Eye Clinic /ID# 234997 - Glen Waverley
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The Lions Eye Institute /ID# 236832 - Nedlands
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Essendon Eye Clinic /ID# 235433 - Essendon
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Geelong Eye Clinic /ID# 236118 - Geelong
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Recruitment hospital [8]
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Vision Eye Institute /ID# 236003 - Melbourne
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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3002 - East Melbourne
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Recruitment postcode(s) [3]
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VIC3065 - Fitzroy
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Recruitment postcode(s) [4]
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3150 - Glen Waverley
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment postcode(s) [6]
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3040 - Essendon
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Recruitment postcode(s) [7]
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3220 - Geelong
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Recruitment postcode(s) [8]
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3058 - Melbourne
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Recruitment outside Australia
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).
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Trial website
https://clinicaltrials.gov/study/NCT02507687
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Trial related presentations / publications
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/87/NCT02507687/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/87/NCT02507687/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02507687