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A Multi-Center, Prospective, Longitudinal, Randomized, Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of Daily Administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the Combination of Pravastatin and Fenofibrate 40/160 mg) for 12 Weeks Followed by a 52-Week Open-Label Safety Phase of the Pravafen Alone in the Treatment of Combined Hyperlipidemia.

Trial Profile

A Multi-Center, Prospective, Longitudinal, Randomized, Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of Daily Administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the Combination of Pravastatin and Fenofibrate 40/160 mg) for 12 Weeks Followed by a 52-Week Open-Label Safety Phase of the Pravafen Alone in the Treatment of Combined Hyperlipidemia.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Fenofibrate/pravastatin (Primary) ; Fenofibrate; Pravastatin
  • Indications Hyperlipidaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Shionogi Pharma
  • Most Recent Events

    • 07 Jul 2009 Actual end date (Jul 2009) and actual number of patients (481) added as reported by ClinicalTrials.gov.
    • 07 Jul 2009 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 10 Oct 2007 Status changed from recruiting to in progress.
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