Evaluation of Patiromer in Heart Failure Patients (PEARL-HF)
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|ClinicalTrials.gov Identifier: NCT00868439|
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : December 15, 2015
Last Update Posted : February 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hyperkalemia Heart Failure||Drug: patiromer Drug: placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of Patiromer in Heart Failure Patients|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||December 2009|
|Active Comparator: patiromer||
Active investigational drug
|Placebo Comparator: placebo||
- Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. [ Time Frame: Baseline and Day 28 ]
- Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L. [ Time Frame: 28 Days ]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 ]Analysis based on local laboratory data.
- Proportion of Participants Whose Spironolactone Dose Was Increased. [ Time Frame: 28 Days ]
- 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 ]
- Time to First Elevated Serum K+ > 5.5 mEq/L. [ Time Frame: 28 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868439
|Study Director:||Director Clinical Operations||Relypsa, Inc.|