A European, observational, three-year cohort comparative study on the safety of the fixed-dose combination pravastatin 40 mg/fenofibrate 160 mg (Pravafenix) versus statin alone in real clinical practice (POSE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38822
• EU PAS number:
  EUPAS13661
• Study ID:
  38822
• Official title and acronym:
  A European, observational, three-year cohort comparative study on the safety of the fixed-dose combination pravastatin 40 mg/fenofibrate 160 mg (Pravafenix) versus statin alone in real clinical practice (POSE)
• DARWIN EU® study:
  No
• Study countries:
  Greece

  Portugal

  Spain
• Study description:
  This is a multicentric, European, comparative, partly retrospective and prospective, observational cohort study with a three-year follow up in patients treated with Pravafenix® or with a statin at standard dose in monotherapy. This study is conducted in real clinical practice conditions of prescription designed to obtain further data on the safety and use of Pravafenix® in real conditions of use. Physicians will be GPs, cardiologists, internists and endocrinologists hospital-based or private practice from at least three European countries (Portugal, Spain and Greece). Physicians will be required not to change their typical practice in treating patients. Baseline information will be collected from the medical records at study treatment initiation and follow-up information will be collected over a period of three years according to the visits performed by the physicians.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 150 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 18/05/2016

Study start date

Actual: 20/12/2016

Date of final study report

Planned: 13/09/2023

Actual: 12/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Laboratoires SMB S.A

Study protocol

Initial protocol

PRAVAFENIX-POSE study-Protocol -version 1 0 (28 July 2016)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)