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Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).

Information source: GE Healthcare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension

Intervention: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) (Drug); Dextrose (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GE Healthcare

Official(s) and/or principal investigator(s):
Christopher Jefferds, Study Director, Affiliation: ICON Development Solutions

Summary

The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.

Clinical Details

Official title: A Phase 4, Placebo Controlled, Single-blind, Cross-over Safety Study to Evaluate the Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR) as Measured by Right Heart Catheterization

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Primary outcome:

Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.

Observed the Change of Pulmonary Vascular Resistance (PVR) Measured by Wood Units Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.

Secondary outcome: Recorded Any Adverse Events From the Optison and Control Solution (5% Dextrose) Used in Subjects With Normal and Elevated Pulmonary Artery Systolic Pressure (PASP. This is Per Sequence and Not a Cross-over Study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must be already scheduled for left and/or right heart catheterization for clinical

reasons.

- Must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess

pulmonary hemodynamics by catheterization, as determined by the investigator.

- Women of childbearing potential must be using adequate birth control and have a

negative pregnancy test. Exclusion Criteria:

- History of right-to-left, bi-directional, or transient right-to-left cardiac shunts

or diagnosed by color flow Doppler echocardiography during screening.

- Hypersensitivity to Optison, perflutren, blood, blood products, or albumin.

- Female subjects who are nursing mothers.

Locations and Contacts

ICON Development Solutions, Elliott City, Maryland 21043, United States
Additional Information

Starting date: March 2009
Last updated: July 19, 2012

Page last updated: August 23, 2015

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