Status: Ongoing First registered on: 14/08/2017
Last updated on: 31/12/2019
1. Study identification
EU PAS Register NumberEUPAS20546
Official titleCohort Study of the Incidence of Major Cardiovascular Events in New Adult Users of Lisdexamfetamine and Remote Adult Users of Other ADHD Treatments
Study title acronym
Study typeObservational study
Brief description of the studyThis study will consist of multiple observational (non-interventional) population-based cohort studies of patients initiating Lisdexamfetamine dimesylate (LDX) compared with patients with remote use of other attention deficit and hyperactivity disorder (ADHD) medications, in three electronic health care data sources: the Danish National Registries, and the Swedish National Registers. The main objective of this study is to estimate the incidence rate (IR) and the adjusted incidence rate ratios (IRRs) of the composite major adverse cardiovascular events (MACE) endpoint in a cohort of adult patients who are current new users of LDX compared with a cohort of remote users of other ADHD treatments. Current use for LDX new users is defined as the duration of the LDX prescription or dispensing plus 30 days. The remote use of other ADHD treatments will be generated by selecting adult patients with at least one prescription/dispensing for a medication indicated for ADHD, other than LDX, during the 24 months prior to the index date and with no prescriptions or dispensings of these medications in at least the last 180 days before index date. The analysis will be conducted separately in each data source, and overall estimates of effect will be obtained using meta-analytic techniques as appropriate. The primary endpoint, MACE, will comprise the first occurrence of any of its individual components during follow-up: hospitalisation for acute myocardial infarction, fatal or non-fatal; hospitalisation for stroke, fatal or non-fatal; out-of-hospital coronary heart disease death; and out-of-hospital cerebrovascular death. Secondary endpoints are an extended MACE (EMACE) endpoint that includes hospitalisation for either unstable angina or TIA, the composite coronary and stroke components of EMACE, and an additional secondary endpoint that will be a composite of sudden cardiac death and serious ventricular arrhythmias.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 2 (specific obligation of marketing authorisation)
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 belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Details of (Primary) lead investigator
Title Dr
Last name Rebordosa
First name Cristina
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

Countries in which this study is being conducted
International study

Denmark
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/06/201701/06/2017
Start date of data collection01/12/201916/10/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report30/06/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesShire Human Genetic Therapies, Inc., a wholly owned subsidiary of the Takeda Pharmaceutical Company Limited100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Rebordosa
First name Cristina
Address line 1Av. Diagonal, 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34933622807 
Alternative phone number 
Fax number (incl. country code) 
Email address crebordosa@rti.org
Public Enquiries
Title Dr 
Last name Rebordosa 
First name Cristina 
Address line 1Av. Diagonal, 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain 
Phone number (incl. country code)34933622807 
Alternative phone number 
Fax number (incl. country code) 
Email address crebordosa@rti.org 
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