Untersuchung der Sicherheit und Wirksamkeit von Alvalin® in einer prospektiven, nicht-interventionellen Sicherheitsstudie (PASS) - Evaluation of safety and efficacy of Alvalin in a prospective, non-interventional safety study (CTU 086H)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Study drug and medical condition

• Medicinal product name, other:
  Alvalin
• Medical condition to be studied:
  Obesity

Population studied

• 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:
  1000

Study design details

• Main study objective:
  Untersuchung der Sicherheit von Alvalin® unter den Bedingungen des Praxisalltags.Evaluation of safety of Alvalin for use in everyday practice.
• Outcomes:
  Erfassung von Art und Häufigkeit von Beschwerden.Collecting of kind and frequency of adverse events. Erfassung von Daten zur Dosierung, der Einnahmedauer, der Unterbrechung (inklusive der Gründe) und der Wirksamkeit unter Praxisbedingungen.Collecting data concerning dosage, duration of intake, interruption of treatment (with reasons) and efficacy for use in everyday practice.
• Data analysis plan:
  - in progress -