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A Dose-Defining Study of CXL-1020 in Patients With Systolic Heart Failure

2014-07-24 14:06:43 | BioPortfolio

Summary

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.

Description

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.

Study Design

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

Conditions

Heart Failure

Intervention

Placebo, Strata 1 CXL-1020, Strata 2 CXL-1020, Strata 3 CXL-1020

Status

Not yet recruiting

Source

Cardioxyl Pharmaceuticals, Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:06:43-0400

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