Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271765
Status:
COMPLETED
Last Update Posted:
2006-11-29
First Post:
2006-01-03
Brief Title:
A Study of INO-1001 an Intravenous PARP Poly ADP Ribose Polymerase Inhibitor in Acute Heart Attack Patients Undergoing Primary Percutaneous Coronary Intervention
Sponsor:
Inotek Pharmaceuticals Corporation
Organization:
Inotek Pharmaceuticals Corporation
Study Overview
Official Title:
A Phase II Randomized Placebo-Controlled Single-Blind Multi-Center Dose-Escalation Study to Evaluate Tolerability Safety Pharmacokinetics and Pharmacodynamics of a Single Intravenous Administration of INO-1001 in Subjects With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to assess the safety of INO-1001 in subjects who have experienced a heart attack and are to be treated with coronary angioplasty
Detailed Description:
Currently heart attacks may be treated with clot-dissolving medicines coronary angioplasty or a combination of both Unblocking of blood flow to the heart following coronary angioplasty can cause side effects such as heart tissue and blood vessel damage abnormal heart rhythms and death of heart muscle cells
In animal studies the PARP enzyme has been shown to be involved in damaging heart muscle after the sudden unblocking of coronary arteries INO-1001 blocks the PARP enzyme and so it may reduce heart damage in humans who have had their coronary arteries unblocked after a heart attack
A total of 40 patients will be selected and randomly assigned to either INO-1001 or placebo sugar water One dose only of the drug will be given prior to coronary angioplasty Patients will be followed until 30 days after surgery
The following information will be gathered vital signs symptoms physical examination blood and urine tests electrocardiograms and other information from medical charts
The information provided in this listing is disclosed solely to comply with regulatory requirements The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group
In animal studies the PARP enzyme has been shown to be involved in damaging heart muscle after the sudden unblocking of coronary arteries INO-1001 blocks the PARP enzyme and so it may reduce heart damage in humans who have had their coronary arteries unblocked after a heart attack
A total of 40 patients will be selected and randomly assigned to either INO-1001 or placebo sugar water One dose only of the drug will be given prior to coronary angioplasty Patients will be followed until 30 days after surgery
The following information will be gathered vital signs symptoms physical examination blood and urine tests electrocardiograms and other information from medical charts
The information provided in this listing is disclosed solely to comply with regulatory requirements The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None