Status: Finalised First registered on: 25/05/2012
Last updated on: 17/08/2016
1. Study identification
EU PAS Register NumberEUPAS2612
Official titleThe risk of developing prostate cancer in entacapone and levodopa/DDCI users compared to levodopa/DDCI users without entacapone - A nation-wide retrospective register-based study
Study title acronym
Study typeObservational study
Brief description of the studyThe purpose of the study is to evaluate whether treatment with entacapone as add-on to levodopa/DDCI increases the risk of developing prostate cancer when comparing to treatment without entacapone as add-on to levodopa/DDCI among male PD patients in Finland.
Was this study requested by a regulator?Yes: United States
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEPID Research
Department/Research group
Organisation/affiliationEPID Research Oy
Website/Homepagewww.epidresearch.com
Details of (Primary) lead investigator
Title Dr
Last name Korhonen
First name Pasi
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Finland
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/02/201121/02/2011
Start date of data collection16/05/201101/12/2011
Start date of data analysis
Date of interim report, if expected
Date of final study report31/10/201225/06/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesOrion Corporation Orion Pharma100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358-50-3652990 
Alternative phone number 
Fax number (incl. country code) 
Email address pasi.korhonen@epidresearch.com
Public Enquiries
Title Dr 
Last name Korhonen 
First name Pasi 
Address line 1EPID Research Oy 
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358-50-3652990 
Alternative phone number 
Fax number (incl. country code) 
Email address pasi.korhonen@epidresearch.com 
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