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A multicentre, randomised, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children

Trial Profile

A multicentre, randomised, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 13 Mar 2020

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At a glance

  • Drugs Potassium bicarbonate/potassium citrate (Primary)
  • Indications Cystinuria
  • Focus Registrational; Therapeutic Use
  • Acronyms CORAL
  • Sponsors Advicenne
  • Most Recent Events

    • 13 Mar 2020 According to an Advicenne media release, the company had received authorization from Belgium's Federal Agency for Medicines and Health Products (FAMHP) to begin this trial in Belgium.
    • 05 Mar 2020 Planned number of patients changed from 72 to 78.
    • 23 May 2019 According to an Advicenne media release, Belgian Hospitals are important contributors for this study.
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