NCT01294709

A Study to Assess the Safety, Tolerability, and Effects of MK-0974 (Telcagepant) on Exercise Tolerance in Patients With Stable Angina (MK-0974-014)

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Angina Pectoris
• Coronary Heart Disease
• Calcitonin Gene-related Peptide Receptor

Interventions

Type	Name	Description
DRUG	telcagepant
DRUG	Placebo to telcagepant

Timeline

• Start date: 2008-02-12
• Primary completion: 2009-02-28
• Completion: 2009-03-13
• First posted: 2011-02-11
• Last updated: 2018-10-18
• Results posted: 2014-09-10