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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Number of Participants With Laboratory Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Telcagepant/ Placebo
Participants receive single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 1 and single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
干预措施: telcagepant (Drug)
Telcagepant/ Placebo
Participants receive single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 1 and single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
干预措施: Placebo to telcagepant (Drug)
Placebo/Telcagepant
Participants receive single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 1 and a single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
干预措施: telcagepant (Drug)
Placebo/Telcagepant
Participants receive single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 1 and a single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
干预措施: Placebo to telcagepant (Drug)
结局指标
主要结局
Number of Participants With Laboratory Adverse Events
时间窗: Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Number of Participants With Clinical Adverse Events (AEs)
时间窗: Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.
Total Exercise Duration on the Treadmill Test
时间窗: 2.5 to approximately 2.75 hours post dose of each treatment period
Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant's electrocardiogram (ECG), symptoms, and arm blood pressure were continuously monitored. Regardless of whether the participant believed he or she could continue, the test was discontinued upon evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia
次要结局
- ST Segment Depression at Peak Exercise(2.5 to approximately 2.75 hours post dose of each treatment period)
- Time to 1 mm ST Segment Depression(2.5 to approximately 2.75 hours post dose of each treatment period)