Evaluation of Patiromer in Heart Failure Patients (PEARL-HF)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of Patiromer in Heart Failure Patients|
- Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
- Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]Analysis based on central laboratory data.
- Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L). [ Time Frame: 28 Days ] [ Designated as safety issue: No ]Analysis based on local laboratory data.
- Proportion of Participants Whose Spironolactone Dose Was Increased. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
- Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
- Time to First Elevated Serum K+ > 5.5 mEq/L. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: patiromer||
Active investigational drug
|Placebo Comparator: placebo||
This was a double-blind, randomized, placebo-controlled, parallel-group, multiple-dose study in congestive heart failure participants. Depending on the outcome from the initial cohort of 100 participants (Part 1), a second cohort of 170 participants could have been enrolled (Part 2). Based on the results of Part 1 of the study, Part 2 was not conducted.
Participants were randomly assigned to and received patiromer (30 g/day) or placebo for up to 28 days. All participants also received spironolactone; the initial spironolactone dose was 25 mg daily and was increased to 50 mg daily for participants who had a serum potassium ≤ 5.1 mEq/L on treatment Day 14. Study visits occurred on treatment Days 3, 7, 14, 17, 21 and 28. A safety follow-up contact was made 7 days after administration of last dose of study drug.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868439
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|Study Director:||Director Clinical Operations||Relypsa, Inc.|