Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02388971
Status:
WITHDRAWN
Last Update Posted:
2015-12-10
First Post:
2015-02-23
Brief Title:
Proof of Mechanism Study of MLN1202 on Atherosclerotic Inflammation in Participants With Stable Atherosclerotic Cardiovascular Disease
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Placebo- Controlled Phase 2a Study to Assess the Effect of CCR2 Antagonism by MLN1202 on Atherosclerotic Inflammation in Subjects With Stable Atherosclerotic Cardiovascular Disease Using FDG PETCT Imaging
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study has withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in participants with stable atherosclerotic cardiovascular disease CVD who are receiving standard-of-care SOC therapy
Detailed Description:
The drug being tested in this study is called MLN1202 MLN1202 is being tested to treat people who have stable atherosclerotic cardiovascular disease CVD This study will look at changes in arterial inflammation in people who take MLN1202 in addition to standard-of-care SOC therapy
The study will enroll approximately 108 participants Participants will be randomly assigned by chance like flipping a coin to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
MLN1202 Dose A intravenously IV
Placebo dummy inactive solution - this is a solution that looks like the study drug but has no active ingredient
All participants will receive IV administration of MLN1202 or placebo on Day 1 Day 29 and Day 57 of this study
This multi-centre trial will be conducted in the United States The overall time to participate in this study is 19 weeks Participants will make 7 visits to the clinic and will be contacted by telephone approximately 35 days after last dose of study drug for a follow-up assessment
The study will enroll approximately 108 participants Participants will be randomly assigned by chance like flipping a coin to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
MLN1202 Dose A intravenously IV
Placebo dummy inactive solution - this is a solution that looks like the study drug but has no active ingredient
All participants will receive IV administration of MLN1202 or placebo on Day 1 Day 29 and Day 57 of this study
This multi-centre trial will be conducted in the United States The overall time to participate in this study is 19 weeks Participants will make 7 visits to the clinic and will be contacted by telephone approximately 35 days after last dose of study drug for a follow-up assessment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1159-5742 | REGISTRY | WHO | None |