Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects
NCT ID: NCT01736735
Last Updated: 2014-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
270 participants
INTERVENTIONAL
2013-01-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CLP
CLP BID
CLP
Placebo
BID powder
placebo
Interventions
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CLP
placebo
Eligibility Criteria
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Inclusion Criteria
* Heart failure with at least one of the following signs of current fluid overload:
1. Peripheral (or sacral) edema \>1+ or ascites during screening or on day of randomization
2. Pulmonary congestion as determined by chest X-ray during the screening period
* Ambulatory and able to perform the 6-minute walk test
Exclusion Criteria
* Any hospitalization or unscheduled outpatient decongestion therapy using IV diuretics, ultrafiltration, or paracentesis within 8 weeks prior to or during screening
* Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 2 months prior to or during screening or anticipated need during study participation
* Heart transplant recipient, or anticipated need for transplant or LVAD during study participation
* Any of the following events having occurred within 8 weeks prior to or during screening: myocardial infarction, transient ischemic attack, stroke, or acute coronary syndrome as judged by the Investigator
21 Years
ALL
No
Sponsors
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Sorbent Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Howard Dittrich, MD
Role: STUDY_CHAIR
Sorbent Therapeutics, Study Sponsor
Locations
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Orange Country Research Center
Tustin, California, United States
Buenos Aires, , Argentina
Ashkelon, , Israel
Countries
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Central Contacts
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Other Identifiers
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CTST-24
Identifier Type: -
Identifier Source: org_study_id
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