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Safety of SonoVue on Pulmonary Hemodynamics

NCT01306292 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-12-07

Study results available
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Summary

This is an intra-subject crossover comparative safety study to evaluate the effect of intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

SonoVue

dose of 4.8 mL administered intravenously one time

DRUG

Placebo

Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)

Sponsors & Collaborators

  • Bracco Diagnostics, Inc

    lead INDUSTRY

Principal Investigators

  • Maria Luigia Storto, MD · Bracco Diagnostics, Inc

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01306292 on ClinicalTrials.gov