| Trial ID: | L1121 |
| Source ID: | NCT01650012
|
| Associated Drug: |
Eplerenone
|
| Title: |
Eplerenone in Hemodialysis Trial
|
| Acronym: |
PHASE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hemodialysis|End Stage Renal Disease
|
| Interventions: |
DRUG: eplerenone|DRUG: Placebo
|
| Outcome Measures: |
Primary: permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension, 13 weeks | Secondary: permanent discontinuation of study drug for any reason, 13 weeks|treatment adherence, 13 weeks|pre-dialysis potassium, 13 weeks|frequency of serious adverse events, 13 weeks|frequency of hospitalizations for a vascular reason, 13 weeks|fatal and non-fatal vascular events, 13 weeks
|
| Sponsor/Collaborators: |
Sponsor: McMaster University | Collaborators: Canadian Institutes of Health Research (CIHR)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
158
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-03
|
| Completion Date: |
2013-12
|
| Results First Posted: |
|
| Last Update Posted: |
2015-09-28
|
| Locations: |
Calgary, Alberta, Canada|Winnipeg, Manitoba, Canada|St. Joseph's Healthcare, Hamilton, Ontario, Canada|London, Ontario, Canada|St. Michael's Hospital, Toronto, Ontario, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT01650012
|
