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Clinical trial

Evaluation of Vepoloxamer in Chronic Heart Failure

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Last updated:1st Oct 2015

The purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical marker and functional benefit to damaged heart muscle cells. This will be evaluated by measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure will be evaluated.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vepoloxamer Injection, 22.5% (Sodium-Free) in Ambulatory Subjects With Chronic Heart Failure
Estimated Enrollment: 150
Study Start Date: October 2015
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Vepoloxamer - Low dose
- Experimental: Vepoloxamer - High dose
- Placebo Comparator: 5% dextrose in water (D5W)

Category Value
Study start date 2015-10-01

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