Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 - The objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during AGA-004.

See also
	Status	Clinical Trial	Phase
	Terminated	`NCT02620761` - Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants	Phase 2/Phase 3
	Completed	`NCT02100683` - Nit-Occlud PDA Post-Approval Study

NCT number	NCT00583596
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Completed
Phase	N/A
Start date	October 1999
Completion date	February 2009

Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms