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Safety and Efficacy Study of PB127 Ultrasound Contrast Agent in Patients With Suspected Coronary Artery Disease 007

NCT00595673 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2008-07-03

No results posted yet for this study

Summary

This trial is to compare PB127 echocardiography to other heart imaging studies.

Conditions

Interventions

DRUG

PB127 for injectable suspension

0.175 mg/kg diluted in 150 mL Dextrose in Water 5% in glass bottles to be infused at 250 mL/hour until stead state achieve, 150 mL/hour during rest image acquisition, and 100-150 mL/hr during stress image acquistion. Single IV infusion, not to exceed 60 minutes.

Sponsors & Collaborators

  • Point Biomedical

    lead INDUSTRY

Principal Investigators

  • Alexander Ehlgen, MD, PhD · POINT Biomedical Corp.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2003-10-31
Completion
2003-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00595673 on ClinicalTrials.gov