Safety of TG100-115 for Heart Attack Treated With Angioplasty

This study has been completed.

Sponsor:

Information provided by:

TargeGen

ClinicalTrials.gov Identifier:

NCT00103350

First received: February 7, 2005

Last updated: May 16, 2008

Last verified: May 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	February 7, 2005
Last Updated Date	May 16, 2008
Start Date ^ICMJE	January 2005
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Safety and pharmacokinetics of TG100-115
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00103350 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Impact of TG100-115 on infarct size
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety of TG100-115 for Heart Attack Treated With Angioplasty
Official Title ^ICMJE	A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective Study to Evaluate the Safety and Potential Efficacy of Single, Increasing Doses of TG100-115 in Subjects Undergoing Percutaneous Coronary Intervention for Acute Anterior ST Elevation Myocardial Infarction
Brief Summary	TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis of this study is that TG100-115 can be given safely to patients who suffer a heart attack and undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces heart muscle damage.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Myocardial Infarction
Intervention ^ICMJE	Drug: TG100-115
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	January 2008
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 18-80 yrs ECG patterns consistent with an acute anterior myocardial infarction with ST segment elevation of 2mm in two contiguous ECG leads among leads V1-V4. Have prolonged, continuous (lasting at least 20 mins) signs and symptoms of myocardial ischemia not eliminated with nitrates. Intent to proceed to primary PCI within 6 hours of chest pain onset Sign an informed consent form and be willing to attend follow-up visits for safety and other study assessments. Exclusion Criteria: Female of childbearing potential. History of previous myocardial infarction. History of congestive heart failure. Requirement for a cardiac pacemaker or defibrillator. Cardiogenic shock. Patients previously treated with thrombolytic therapy. Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00103350
Other Study ID Numbers ^ICMJE	TG001-03
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	TargeGen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	TargeGen
Verification Date	May 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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