Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441701
Status:
TERMINATED
Last Update Posted:
2019-01-02
First Post:
2007-02-28
Brief Title:
Study to Evaluate the Safety and Dose-Range of Navarixin SCH 527123 MK-7123 in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease COPD MK-7123-012
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Safety and Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD
Status:
TERMINATED
Status Verified Date:
2018-12
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:
This is a two-part study conducted at multiple centers of navarixin SCH 527123 MK-7123 in participants with moderate to severe chronic obstructive pulmonary disease COPD Part 1 of the study is a double-blind placebo-controlled randomized rising-dose study consisting of four treatment groups enrolled in three cohorts The duration of treatment for each cohort will be a 2-week run-in period followed by a 12-week double-blind treatment period Treatment initiation for each cohort was staggered by 4 weeks to allow for safety assessment prior to use of higher doses of navarixin Part 2 of the study will be a double-blind placebo-controlled randomized parallel group study consisting of four treatment groups enrolled as one cohort The duration of treatment will consist of a 2-week run-in period followed by a 12-week double-blind treatment period
Detailed Description:
None
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 |
|---|---|---|---|
| 2005-004287-23 | EUDRACT_NUMBER | Merck Protocol Number | None |
| P04592 | OTHER | None | None |