Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent

This study has been terminated.
(Discontinued PB127 development program for business reasons)
Sponsor:
Information provided by:
Point Biomedical
ClinicalTrials.gov Identifier:
NCT00584714
First received: December 20, 2007
Last updated: July 1, 2008
Last verified: July 2008

December 20, 2007
July 1, 2008
October 2007
July 2008   (final data collection date for primary outcome measure)
To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00584714 on ClinicalTrials.gov Archive Site
Not Provided
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Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent
Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent

The purpose of this study is to collect longer term follow-up information concerning health and survival on selected patients who received PB127 for injectable suspension in the pivotal trial (127-014).

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Subjects with low/very low pre-test probability of coronary artery disease enrolled in Protocol 127-014 who did not have or were not schedule to undergo coronary angiography at the time of enrollment and did not have a clinical outcome during the initial 6 month follow-up period.

Coronary Artery Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients enrolled in Protocol 127-014 who

  1. Were enrolled in Stratum 1
  2. Did not undergo angiography during study evaluation
  3. Did not have a clinical oucome during the initial 6 month follow-up period as described in Protocol 127-014.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584714
127-014-A
No
Tom Ottoboni PhD/Chief Operating Officer, POINT Biomedical Corp.
Point Biomedical
Not Provided
Study Director: Alexander Ehlgen, MD, PhD POINT Biomedical Corp.
Point Biomedical
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP