Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132730
Status:
TERMINATED
Last Update Posted:
2018-10-12
First Post:
2005-08-03
Brief Title:
An Investigational Drug Study In Patients With COPD Chronic Obstructive Pulmonary Disease MK-0873-005
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Multicenter Parallel-Group Dose-Ranging Study of MK-0873 in Patients With COPD
Status:
TERMINATED
Status Verified Date:
2018-09
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 study to evaluate the effectiveness and tolerability of a once-daily oral medication MK-0873 for the treatment of COPD chronic obstructive pulmonary disease to determine whether the study drug leads to an improvement in pulmonary lung function as well as symptoms and quality of life
Detailed Description:
Following a three-week run-in period Period I during which participants received placebo participants entered into a 12-week double-blind treatment period Period II during which they received daily doses of either one of three doses of MK-0873 or placebo Period I and Period II made up the Base Study Following the 12-week treatment period in the Base Study participants were invited to continue in an optional 12-week double-blind extension study Period III EXT1 Participants who received any dose of MK-0873 in the Base Study continued on MK-0873 25 mg daily in Period III while participants in the placebo arm of the Base Study continued on placebo daily Following EXT1 participants were invited to continue in an optional open-label second extension study EXT2 which was to last 80 weeks Period IV 28 weeks Period V 52 weeks In EXT2 participants who had been taking MK-0873 25 mg in the Base Study were allocated to MK-0873 25 mg plus usual care while participants who had been taking the other two doses of MK-0873 or placebo in the Base Study were allocated to either MK-0873 25 mg plus usual care or to usual care alone
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_015 | OTHER | Telerex Study ID | None |