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Safety and Hemodynamic Effects and Pharmacokinetics of CXL-1020 in Patients With Stable Heart Failure

2014-07-23 21:09:45 | BioPortfolio

Summary

A Phase 1-2a Study of CXL-1020-01 in Patients with Stable Heart Failure

Description

This is a Phase I/IIa Dose-Escalation, First exposure in Humans, Study Evaluating the Safety and Tolerability of CXL-1020 and Specific Effects on Electrocardiographic and Non-Invasive Hemodynamic Parameters in Patients with Chronic Heart Failure. 4 weekly four-hour treatments involving ascending dosages of CXL-1020 with a randomly interspersed placebo dose within two or more unique patient cohorts. Separate echocardiography cohorts (Echo Cohort A and Echo Cohort B) will evaluate a sustained dose over 4 hours (ECHO A), and an ascending two dose level, 4-hour infusion (2 hours each) (ECHO B), in individual patients. Echo Cohort dosages will be determined from responses observed in previous cohort exposures.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Heart Failure

Intervention

CXL-1020, CXL-1020, Placebo for CXL-1020 Cohort 1, Placebo for CXL-1020 Cohort 2, CXL-1020 Dose for Echo Cohort A, CXL-1020 Doses for Echo Cohort B

Location

Orange County Clinical Research Center
Tustin
California
United States
92780

Status

Recruiting

Source

Cardioxyl Pharmaceuticals, Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:45-0400

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