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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/39374
• EU PAS number:
  EUPAS5084
• Study ID:
  39374
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Untersuchung der Sicherheit von Alvalin® unter den Bedingungen des Praxisalltags. Weiterhin sollen Daten zur Dosierung, der Einnahmedauer, der Unterbrechung (inklusive der Gründe) und der Wirksamkeit unter Praxisbedingungen erhoben werden. Evaluation of safety of Alvalin for use in everyday practice. Furthermore data concerning dosage, duration of intake, interruption of treatment (with reasons) and efficacy for use in everyday practice should be collected.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Riemser Pharma

Study timelines

Date when funding contract was signed

Planned: 25/10/2013

Actual: 25/10/2013

Study start date

Planned: 13/01/2014

Actual: 31/01/2014

Data analysis start date

Planned: 01/02/2021

Actual: 01/02/2021

Date of final study report

Planned: 14/01/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

RIEMSER Pharma GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable