Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects

• Status: Unknown status
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sorbent Therapeutics

Criteria

Selected Inclusion Criteria:

• Age 21 years or older at randomization

• 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

Selected Exclusion Criteria:

• Participation in another clinical trial of an investigational or marketed drug within 30 days or 5 half-lives (whichever is longer) preceding screening

• 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