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

NCT01096043 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2016-11-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Placebo

An infusion of an identically appearing solution of sugar water will be intravenously administered.

DRUG

Strata 1 CXL-1020

Intravenous infusion of CXL-1020, up-titrated, so that 3 different dosages are administered over 6 hours

DRUG

Strata 2 CXL-1020

One of 3 different dosages of CXL-1020 administered at a fixed dosage level for 6 hours.

DRUG

Strata 3 CXL-1020

A fixed dose level of CXL-1020 will be administered for the initial 6 hours of treatment in Strata 3 and then dosage will be altered up or downward based on the investigators observation of the patient's condition.

Sponsors & Collaborators

Principal Investigators

  • Wilson Colucci, M.D. · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01096043 on ClinicalTrials.gov