Ignite Creation Date:
2024-05-06 @ 8:07 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02678923
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2016-02-05
Brief Title:
MDCO-216 Infusions Leading to Changes in Atherosclerosis A Novel Therapy in Development to Improve Cardiovascular Outcomes - Proof of Concept Intravascular Ultrasound IVUS Lipids and Other Surrogate Biomarkers Trial
Sponsor:
The Medicines Company
Organization:
The Medicines Company
Study Overview
Official Title:
A Placebo-controlled Double-blind Randomized Trial to Compare the Effect of Treatment on Plaque Burden as Determined by Intravascular Ultrasound and to Evaluate the Efficacy Pharmacokinetics Safety and Tolerability of MDCO-216 Given as Multiple Weekly Infusions in Subjects With a Recent Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2017-06
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:
PILOT
Brief Summary:
This study will be a proof-of-concept placebo-controlled double-blind randomized trial in participants with a recent acute coronary syndrome ACS to evaluate the efficacy pharmacokinetics safety tolerability disease progression measures by IVUS and pharmacodynamics of MDCO-216 infusion Eligible participants will be randomized to receive 5 infusions of MDCO-216 20 milligramskilogram mgkg or placebo in a 11 ratio
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-000826-13 | EUDRACT_NUMBER | None | None |