| Trial ID: | L1432 |
| Source ID: | NCT01265524
|
| Associated Drug: |
Clp
|
| Title: |
Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01265524/results
|
| Conditions: |
Heart Failure
|
| Interventions: |
DRUG: CLP|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Serum Potassium, Change in serum potassium from baseline to Week 8., Baseline and 8 weeks | Secondary: Weight Loss at Week 1, Baseline and 1 week|Weight Loss at Week 2, Baseline and 2 weeks|Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4, The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4., 4 weeks|Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8, The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8., 8 weeks|Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8, Baseline and 8 weeks|6MWT Distance at Week 8, Increase in the 6 minute walk test (6MWT) distance from baseline to Week 8. The test was performed according to the American Thoracic Society (ATS)Guidelines 2002., Baseline and 8 weeks
|
| Sponsor/Collaborators: |
Sponsor: Sorbent Therapeutics | Collaborators: Pharmaterra
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
113
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2011-04
|
| Completion Date: |
|
| Results First Posted: |
2013-03-13
|
| Last Update Posted: |
2013-03-13
|
| Locations: |
Yerevan, Armenia|Tbilisi, Georgia|Chisinau, Moldova, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01265524
|
