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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03748641
Registration number
NCT03748641
Ethics application status
Date submitted
19/11/2018
Date registered
21/11/2018
Date last updated
15/08/2024
Titles & IDs
Public title
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
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Scientific title
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer
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Secondary ID [1]
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2017-003364-12
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Secondary ID [2]
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CR108534
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Universal Trial Number (UTN)
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Trial acronym
MAGNITUDE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Castration-Resistant Prostatic Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Niraparib
Treatment: Drugs - Abiraterone Acetate
Treatment: Drugs - Prednisone
Treatment: Drugs - Placebo
Treatment: Drugs - New Formulation of Niraparib and Abiraterone Acetate (AA)
Experimental: Cohort 1: Participants with mCRPC and HRR Gene Alteration - Participants with L1 metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alteration will receive combination of niraparib 200 milligrams (mg) or matching placebo and abiraterone acetate (AA) 1000 mg plus prednisone 10 mg. In the open label extension (OLE) phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.
Experimental: Cohort 2: Participants with mCRPC and No HRR Gene Alteration - Participants with L1 mCRPC and no HRR Gene alteration will receive combination of niraparib 200 mg or matching placebo and AA 1000 mg plus prednisone 10 mg. In the OLE phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.
Experimental: Cohort 3 (Open-label): Participants with mCRPC - Participants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.
Treatment: Drugs: Niraparib
Participants will receive niraparib 200 mg capsules or tablets once daily.
Treatment: Drugs: Abiraterone Acetate
Participants will receive AA 1000 mg tablets once daily.
Treatment: Drugs: Prednisone
Participants will receive prednisone 10 mg tablets daily.
Treatment: Drugs: Placebo
Participants will receive matching placebo once daily.
Treatment: Drugs: New Formulation of Niraparib and Abiraterone Acetate (AA)
Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.
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Intervention code [1]
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Treatment: Drugs
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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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Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [1]
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As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; (2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (\>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan \>=2 new lesions indicate progression; scan does not show \>=2 new lesions means no progression. If Week 8 scan less than (\<) 2 new bone lesions compared to baseline, the initial scan \>=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan \>=6 weeks later.
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Timepoint [1]
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Up to 32 months
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Primary outcome [2]
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Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [2]
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As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by CT or MRI as per RECIST 1.1; (2) Progression of bone lesions observed by bone scan based on PCWG3 criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan \>=6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan \>=2 new lesions indicate progression; scan does not show \>=2 new lesions means no progression. If Week 8 scan \<2 new bone lesions compared to baseline, the initial scan \>=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan \>=6 weeks later.
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Timepoint [2]
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Up to 32 months
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Secondary outcome [1]
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Cohort 1: Overall Survival (OS)
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Assessment method [1]
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Timepoint [1]
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Up to 97 months
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Secondary outcome [2]
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Cohort 1: Time to Symptomatic Progression
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Assessment method [2]
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Timepoint [2]
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Up to 97 months
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Secondary outcome [3]
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Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
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Assessment method [3]
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Timepoint [3]
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Up to 97 months
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Secondary outcome [4]
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Observed Plasma Concentrations of Niraparib
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Assessment method [4]
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Timepoint [4]
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Up to 97 months
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Secondary outcome [5]
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Observed Plasma Concentrations of Abiraterone
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Assessment method [5]
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Timepoint [5]
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Up to 97 months
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Secondary outcome [6]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [6]
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Timepoint [6]
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Up to 96 months
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Secondary outcome [7]
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Number of Participants With Treatment-Emergent Adverse Events by Severity
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Assessment method [7]
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Timepoint [7]
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Up to 96 months
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Secondary outcome [8]
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Number of Participants With Abnormalities in Laboratory Values
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Assessment method [8]
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Timepoint [8]
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Up to 96 months
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Eligibility
Key inclusion criteria
* HRR gene alteration (as identified by the sponsor's required assays) as follows:
1. Cohort 1: positive for HRR gene alteration
2. Cohort 2: not positive for DRD (that is, HRR gene alteration)
3. Cohort 3: eligible by HRR status
* Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
* Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
* Able to continue GnRHa during the study if not surgically castrate
* Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
* Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
* Symptomatic brain metastases
* History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
* Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy
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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
The people analysing the results/data
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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
Active, not recruiting
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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
25/01/2019
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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
19/02/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
765
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Recruitment in Australia
Recruitment state(s)
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Royal Adelaide Hospital - Adelaide
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Pindara Private Hospital - Benowa
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Sunshine Coast University Hospital - Birtinya
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Princess Alexandra Hospital - Brisbane
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St Vincent s Hospital Sydney - Darlinghurst
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Royal Hobart Hospital - Hobart
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Macquarie University - Macquarie University
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Eye Surgery Associates - Malvern
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Peter MacCallum Cancer Centre - Melbourne
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Fiona Stanley Hospital - Murdoch
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Hollywood Private Hospital - Nedlands
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Prince Of Wales Hospital - Randwick
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Sydney Adventist Hospital - Wahroonga
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Wollongong Private Hospital - Wollongong
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5000 - Adelaide
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4217 - Benowa
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4575 - Birtinya
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4102 - Brisbane
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2010 - Darlinghurst
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7000 - Hobart
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2109 - Macquarie University
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3144 - Malvern
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3000 - Melbourne
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6150 - Murdoch
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6009 - Nedlands
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2031 - Randwick
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2076 - Wahroonga
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2500 - Wollongong
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Kyiv
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United Kingdom
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Truro
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.
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Trial website
https://clinicaltrials.gov/study/NCT03748641
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Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
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Address
0
0
Janssen Research & Development, LLC
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Country
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0
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Phone
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Fax
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Email
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No information has been provided regarding IPD availability
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No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/41/NCT03748641/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/41/NCT03748641/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03748641
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