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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00908596
Registration number
NCT00908596
Ethics application status
Date submitted
26/05/2009
Date registered
27/05/2009
Date last updated
23/07/2015
Titles & IDs
Public title
Primovist / Eovist in Renally Impaired Patients
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Scientific title
Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Primovist/Eovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information.
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Secondary ID [1]
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2008-005867-33
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Secondary ID [2]
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13701
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Universal Trial Number (UTN)
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Trial acronym
PERI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Contrast Media
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Gadoxetic acid disodium (Primovist, BAY86-4873)
Experimental: Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873) - Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously.
Treatment: Drugs: Gadoxetic acid disodium (Primovist, BAY86-4873)
Primovist/Eovist in approved indications at approved dosages
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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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Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information
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Assessment method [1]
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A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.
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Timepoint [1]
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Up to 24 months following the administration of Primovist/Eovist
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Secondary outcome [1]
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Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score
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Assessment method [1]
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Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.
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Timepoint [1]
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Up to 24 months following the administration of Primovist/Eovist
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Secondary outcome [2]
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Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
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Assessment method [2]
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The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.
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Timepoint [2]
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Immediately after Primovist/Eovist-enhanced MRI
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Secondary outcome [3]
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Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection
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Assessment method [3]
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The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
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Timepoint [3]
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Immediately after Primovist/Eovist-enhanced MRI
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Secondary outcome [4]
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Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation
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Assessment method [4]
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The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
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Timepoint [4]
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Immediately after Primovist/Eovist-enhanced MRI
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Secondary outcome [5]
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Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization
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Assessment method [5]
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The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.
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Timepoint [5]
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Immediately after Primovist/Eovist-enhanced MRI
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Eligibility
Key inclusion criteria
* Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications
* Patient must fulfill criteria for moderate (Estimated glomerular filtration rate [eGFR] 30 - 59 mL/min/1.73 m^2) to severe (eGFR < 30 mL/min/1.73 m^2) renal impairment.
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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
* Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
* History of existing NSF
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
NA
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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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
1/05/2009
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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
1/07/2013
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Sample size
Target
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Accrual to date
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Final
357
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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- Herston
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Recruitment hospital [2]
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- Woollongabba
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Recruitment hospital [3]
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- Adelaide
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Recruitment hospital [4]
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- Geelong
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Recruitment hospital [5]
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- Westmead NSW
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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4102 - Woollongabba
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3220 - Geelong
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Recruitment postcode(s) [5]
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2145 - Westmead NSW
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Hawaii
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Kansas
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Maryland
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United States of America
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Michigan
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New York
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North Carolina
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Tennessee
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United States of America
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Texas
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Austria
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Graz
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Austria
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Wien
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Thüringen
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Germany
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Berlin
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Italy
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Milano
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Italy
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Napoli
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Italy
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Torino
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Italy
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Brescia
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Italy
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Palermo
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Italy
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Pisa
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Korea, Republic of
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South Korea
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Korea, Republic of
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Seoul
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Spain
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Granada
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Thailand
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Bangkok
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Thailand
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Songkhla
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United Kingdom
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Bristol
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bayer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate. The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist. Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.
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Trial website
https://clinicaltrials.gov/study/NCT00908596
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bayer Study Director
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Address
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Bayer
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00908596
Download to PDF