Drug Utilisation Study of Intuniv® (guanfacine extended release) in European Countries, Study protocol I: Database study (Intuniv data base study Europe)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multi-country retrospective analysis

Study drug and medical condition

• Medicinal product name:
  INTUNIV
• Study drug International non-proprietary name (INN) or common name:
  GUANFACINE HYDROCHLORIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A) ALIMENTARY TRACT AND METABOLISM

  ALIMENTARY TRACT AND METABOLISM

  (C02AC02) guanfacine

  guanfacine
• Medical condition to be studied:
  Attention deficit hyperactivity disorder

Population studied

• Short description of the study population:
  The study population included patients with attention deficit hyperactivity disorder (ADHD) who have been prescribed Intuniv® identified from the electronic medical record databases and national registries.
• Age groups:
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with attention deficit/hyperactivity disorder
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  Overall: Drug utilization study for the next 5 years with Intuniv® with annual data in European countries. Study objectives: 1.characterize patients, focussing on indications other than ADHD, children <6 years, adults 2. describe prescribing patterns of Intuniv® among physicians 3. assess compliance with indication, visits and measurements needed during the first year of treatment</6></6>
• Data analysis plan:
  The analysis will be done descriptively as specified in the statistical analysis plan.