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Phase 1 N=64 Randomized Double-blind Treatment

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

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

Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Number of Participants With Clinical Adverse Events (AEs) — 7; 1; 5 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
telcagepant (Drug); Placebo to telcagepant (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Merck Sharp & Dohme LLC
Primary completion
Feb 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Clinical Adverse Events (AEs)
7; 1; 5
PRIMARY
Number of Participants With Laboratory Adverse Events
0; 0; 0
PRIMARY
Total Exercise Duration on the Treadmill Test
405.38; 412.28
SECONDARY
ST Segment Depression at Peak Exercise
-1.91; -1.86
SECONDARY
Time to 1 mm ST Segment Depression
363.53; 370.67

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.

Eligibility Criteria

Inclusion:

  • Participant has clinically documented stable coronary artery disease as demonstrated by coronary angiography, echocardiogram, or stress test, etc., or participant is on stable doses of current medication for the treatment of coronary artery disease for a minimum of 30 days.
  • Participant has a history of stable angina (chronic stable angina pectoris that is triggered by physical effort and relieved by rest and/or sublingual nitroglycerin) for at least 3 months prior to study start, with no intervening symptoms of unstable angina.
  • Participant is able to demonstrate reproducibly positive exercise tests by completing treadmill tests on 2 separate days, within 1-8 days.
  • Participant agrees to refrain from drinking alcohol from 24 hours prior to study drug administration, on study procedure days, and until release from the study facility.
  • Participants agrees to refrain from smoking from midnight before study procedures until study procedures are complete for the day.
  • Participant has no clinically significant abnormality on screening laboratory safety assessment.
  • Participant agrees to refrain from unaccustomed strenuous physical activity from the prestudy (screening) visit, throughout the study, and until the post-study visit.

Exclusion:

  • Participant is pregnant (positive serum beta-human chorionic gonadotropin [β-hCG] test at prestudy), breast-feeding, or is a female expecting to conceive within the projected duration of the study. Postmenopausal women who are currently using hormone replacement therapy are excluded from participation in the study.
  • Participant has electrocardiogram (ECG) findings that interfere with ECG interpretation or may cause false positive stress test (e.g., > 1 mm horizontal or downsloping ST-segment depression at rest in any standard electrocardiographic lead, Lown-Ganong-Levine syndrome, Wolff-Parkinson-White (WPW), left bundle branch block (LBBB), left ventricular hypertrophy (LVH) with repolarization abnormality, pectus excavatum, ventricular pacemaker, etc.). Note: these ECG findings may affect stress test results; there may be other findings that have not been included which may affect test results. These ECG findings are exclusions only if these findings may jeopardize interpretation of stress test results.
  • Participant has heart rate-corrected QT interval (QTc) (Bazett) > 500 ms on resting ECG.
  • Participant has uncontrolled high blood pressure at prestudy screening.
  • Participant has a baseline heart rate of 96 beats per minute at screening.
  • Participant has unstable angina, hypertrophic cardiomyopathy, valvular heart disease, congenital cardiac defect, severe aortic stenosis, class III or IV heart failure.
  • Participant has diabetes and is, in the opinion of the investigator, unable to comply with the pre-and post-dosing fasting requirements of the study due to risks of hypoglycemia.
  • Participant is unable to withhold acetohexamide, chlorpropamide, glimepride, glimepiride and pioglitazone, glimepride and rosiglitazone, glipizide, glipizide and metformin, glyburide, glyburide and metformin, tolazamide, tolbutamide, or any other medication, that in the opinion of the investigator is likely to result in hypoglycemia within 8 hours of dosing.
  • Participant has had myocardial infarction or coronary revascularization within the prior 2 months.
  • Participant has acute myocarditis or pericarditis.
  • Participant is obese, with adipose tissue which may interfere with ECG interpretation, or in the opinion of the investigator, whose obesity puts the participant at medical risk.
  • Participant has clinically significant hypokalemia or hypomagnesemia.
  • Participant has a history of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
  • Participant must not have taken any of the following medications in the time frame specified: Participant is unable to refrain
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01294709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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