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Study CXL-1020-02 employs is designed to further define suitable clinical dosages for CXL-1020 which will be utilized in a later Phase IIb study. The study is conducted in 3 different stages called 'strata" and evaluates the potential utility of this drug for the treatment of patents who are hospitalized with heart failure.
Each of the 3 strata are described below:
Invasive Strata 1: This is a randomized, double-blinded stratum that will enroll approximately 15 patients who are hospitalized with symptomatic heart failure who have indwelling PA catheters allowing invasive hemodynamic evaluation. Each patient will receive a six hour intravenous infusion of either placebo or CXL-1020.
Non-Invasive Strata 2: This is a randomized, double-blinded stratum which will enroll up to approximately 36 patients who neither require, nor have in place, an indwelling PA catheter for hemodynamic monitoring, but meet study entrance criteria for both symptoms of heart failure and specific echocardiography criteria. Monitoring of drug effects will be performed by Echocardiography.
Invasive-Strata 3: This is a randomized, double-blinded stratum that will begin after an evaluation of a substantial number of patients in Strata A and B and will enroll approximately 15 patients using the same general enrollment criteria as in Invasive Strata A.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Placebo, Strata 1 CXL-1020, Strata 2 CXL-1020, Strata 3 CXL-1020
Not yet recruiting
Cardioxyl Pharmaceuticals, Inc
Published on BioPortfolio: 2014-07-24T14:06:43-0400
A Phase 1-2a Study of CXL-1020-01 in Patients with Stable Heart Failure
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