At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 114 enrolled
Drug / intervention
patiromerdrug
Likely dose
patiromer 8.4 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating patiromer for Hyperkalemia. Completed, enrolled 114 participants across 29 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperkalemia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedFeb 2016
Primary CompletionJul 2016
Study CompletionAug 2016
TodayJul 2026
First PostedFeb 29, 2016
Enrollment StartFeb 1, 2016
Primary CompletionJul 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.3 years ago
Interventions
patiromerdrug
8.4 g/day starting dose, administered orally