Physician Survey to Reassess Effectiveness of Strattera Risk Minimisation Activities

Study type

• Study topic:
  Human medicinal product
• Study type:
  Not applicable
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• If ‘Not applicable’, further details on the study type:
  Survey
• Data collection methods:
  Primary data collection

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA09) atomoxetine

  atomoxetine

Population studied

• Short description of the study population:
  Physicians (Peadiatricians, Child/Adolescent Psychiatrists or other NonPeadiatricians and GPs) who prescribe Strattera and/or monitor patients treated with Strattera
• Age groups:
  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)
• Estimated number of subjects:
  550

Study design details

• Main study objective:
  Re-assessment of the effectiveness of the atomoxetine risk minimisation activities among physicians who prescribe Strattera and/or monitor patients being treated with Strattera. The goal of these activities is to inform HCPs of the cardiovascular or cerebrovascular disorder contraindication and SPC recommendation to monitor BP and HR in all patients at baseline and during treatment with Strattera
• Outcomes:
  The risk minimisation activities assessed by this survey include sustained knowledge and awareness of the risk messages, The survey will also include an assessment of awareness and adherence to the changes in the SmPC requirements specific to cardiovascular risks and monitoring
• Data analysis plan:
  Data analyses will be descriptive and will entail tabular displays of mean values and the frequency distribution of item responses.

Documents

Study results

B024 PASS

Study, other information

RMiP PASS protocol_p2