Ignite Creation Date:
2024-05-05 @ 11:15 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01294709
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2011-02-10
Brief Title:
A Study to Assess the Safety Tolerability and Effects of MK-0974 Telcagepant on Exercise Tolerance in Patients With Stable Angina MK-0974-014
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled 2-Period Crossover Study to Assess the Safety Tolerability and Effects of MK-0974 on Exercise Tolerance in Patients With Stable Angina
Status:
COMPLETED
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 study will assess the safety of telcagepant in coronary artery disease CAD participants with stable angina during exercise treadmill testing and evaluate whether calcitonin gene-related peptide CGRP receptor antagonism by telcagepant reduces exercise tolerance in these participants Primary hypothesis is that telcagepant does not significantly decrease exercise duration compared to placebo as measured by a treadmill exercise test that is the true treatment difference in exercise duration MK-0974 - Placebo -60 seconds
Detailed Description:
Amendment 3 of the protocol reduced the dose of telcagepant to be administered from a single dose of 900 mg to a single dose of 600 mg Pooled data from both the 600-mg and the 900-mg group wiil be utilized in the analyses Also due to supply issues regarding the 300 mg telcagepant capsules 280 mg telcagepant tablets with demonstrated bioequivalence to the 300 mg telcagepant capsules could be administered to participants enrolled after the implementation of Amendment 3
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