The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)

Trial Profile

The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)

Completed
Phase of Trial: Phase IV

Latest Information Update: 30 Aug 2017

At a glance

  • Drugs Patiromer (Primary)
  • Indications Hyperkalaemia
  • Focus Therapeutic Use
  • Acronyms TOURMALINE
  • Sponsors Relypsa
  • Most Recent Events

    • 30 Aug 2017 Results (n=653) of pooled post hoc analysis assessing effect of patiromer on serum K+ in patients with HK and HF using data from AMETHYST-DN, OPAL-HK and TOURMALINE trials presented at the ESC Congress 2017: Annual Congress of the European Society of Cardiology
    • 19 Apr 2017 According to a Relypsa media release, data from the study were presented in a poster session at the National Kidney Foundation (NKF) 2017.
    • 19 Apr 2017 According to a Relypsa media release, the company plans to submit a supplemental New Drug Application to the FDA to revise the Veltassa label to reflect the data from the study.
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