Phase 2 N=36 Randomized Triple-blind

Safety of SonoVue on Pulmonary Hemodynamics

Pulmonary Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01306292 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline — 50.50; 50.50; 30.08; 30.08 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SonoVue (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bracco Diagnostics, Inc
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline	50.50; 50.50; 30.08; 30.08; -2.17; -3.33	—
PRIMARY Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline	24.11; 24.11; 11.72; 11.72; -3.39; -1.50	—
PRIMARY Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline	307.189; 307.189; 142.714; 142.714; -73.087; -63.065	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Provides written informed consent male or female at least 18 years of age scheduled to undergo right heart catheterization for clinical reasons

Exclusion Criteria

Pregnant or lactating females
Significant arrhythmia or non-sinus rhythm that may affect the ability to assess pulmonary hemodynamics by catheterization
Known allergy to one of the ingredients in the investigational product or to any other contrast agents including ultrasound contrast agents
Previously entered into the study or received an investigational compound within 30 days before admission into the study
Unstable pulmonary and/or systemic hemodynamic condition that would affect the ability to evaluate the pharmacological or hemodynamic effect of the investigational products

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01306292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.