Study of evidence of potential selective prescribing of clenbuterol compared to other beta-2-agonists (Clenbuterol selective prescribing)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34902
• EU PAS number:
  EUPAS34901
• Study ID:
  34902
• Official title and acronym:
  Study of evidence of potential selective prescribing of clenbuterol compared to other beta-2-agonists (Clenbuterol selective prescribing)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Patients with a first prescription for a beta-2-agonist and at least 180 days of observation were considered. Respiratory diagnoses on the date of the first prescription, and events in the history of the patients were identified that may suggest that clenbuterol is selectively prescribed for purposes of muscle building, weight management or sports, or to patients at risk of abuse.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 26/03/2020

Actual: 26/03/2020

Study start date

Planned: 26/03/2020

Actual: 26/03/2020

Data analysis start date

Planned: 26/03/2020

Actual: 26/03/2020

Date of final study report

Planned: 23/04/2020

Actual: 23/04/2020

Sources of funding

EMA

Study protocol

Initial protocol

Clenbuterol

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable