Abstract | OBJECTIVE: BACKGROUND: METHODS: In this randomized, double-blind, placebo-controlled, crossover study, patients with documented stable coronary artery disease were assigned to 1 of 2 treatment sequences: telcagepant then placebo, or placebo then telcagepant. In each treatment period, patients received 2 doses of telcagepant 300-mg or placebo 2 hours apart. They remained in the research center for 24 hours after receiving the first dose of each period, during which time continuous 12-lead ambulatory electrocardiographic (Holter) monitoring was performed. RESULTS: Twenty-eight patients were enrolled; all patients completed the study and were included in all analyses. Telcagepant was generally well tolerated. No laboratory or serious adverse experiences were reported, and no patient discontinued due to an adverse experience. There were no consistent treatment-related changes in laboratory, vital signs or electrocardiogram safety parameters. Three patients (2 after receiving placebo and 1 after receiving telcagepant) experienced ST segment depression during the study; none of these patients reported chest pain. CONCLUSIONS:
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Authors | Martin O Behm, Rebecca L Blanchard, M Gail Murphy, John S Palcza, Dawn E Harris, Kristin L Butterfield, William B Smith, Richard A Preston, Jeffrey A Chodakewitz, Mitchell W Krucoff |
Journal | Headache
(Headache)
Vol. 51
Issue 6
Pg. 954-60
(Jun 2011)
ISSN: 1526-4610 [Electronic] United States |
PMID | 21631478
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2011 American Headache Society. |
Chemical References |
- Azepines
- Imidazoles
- telcagepant
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Topics |
- Adult
- Aged
- Azepines
(administration & dosage, adverse effects)
- Cross-Over Studies
- Double-Blind Method
- Female
- Humans
- Imidazoles
(administration & dosage, adverse effects)
- Male
- Middle Aged
- Migraine Disorders
(complications, drug therapy)
- Myocardial Ischemia
(complications, diagnosis, prevention & control)
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