Zagallo Capsules Drug Use Investigation (202029)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48259
• EU PAS number:
  EUPAS12703
• Study ID:
  48259
• Official title and acronym:
  Zagallo Capsules Drug Use Investigation (202029)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  This investigation will be implemented to collect and evaluate the information on safety and effectiveness of Zagallo Capsules in male patients with androgenetic alopecia in daily clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Multiple centres: 800 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 24/09/2014

Study start date

Planned: 30/03/2016

Actual: 22/07/2016

Date of final study report

Planned: 30/09/2019

Actual: 13/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-202029-protocol-redact

Regulatory

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