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

NCT01092325 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-07-01

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

CXL-1020

Intravenous infusion of one of 3 active dosages of CXL-1020

DRUG

CXL-1020

Intravenous infusion of one of 3 active dosages of CXL-1020 at dosages higher than in Cohort 1

DRUG

Placebo for CXL-1020 Cohort 1

A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water)

DRUG

Placebo for CXL-1020 Cohort 2

A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water)

DRUG

CXL-1020 Dose for Echo Cohort A

A 4 hour fixed dose of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect

DRUG

CXL-1020 Doses for Echo Cohort B

A 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect followed by another higher 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect

Sponsors & Collaborators

Principal Investigators

  • Doug Cowart, Pharm D. · Cardioxyl Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092325 on ClinicalTrials.gov