A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of GS-6615 in Subjects With Chronic Stable Angina and Coronary Artery Disease
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change from baseline in time to 1 mm ST-segment depression
研究概览
简要总结
This study will evaluate the effect of GS-6615 in adults with chronic stable angina and coronary artery disease (CAD) receiving a stable daily dose of up to 2 antianginal medications. The study will consist of two periods: a 1 to 3 week Qualifying Period and a Treatment Period lasting 13 days (± 3 days). During the Qualifying Period and at the end of the Treatment Period, participants will undergo exercise tolerance testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to perform a standardized treadmill exercise protocol
- •At least a 3 month history of chronic stable angina triggered by physical effort and relieved by rest and/or short-acting nitroglycerin
- •Coronary artery disease (CAD) documented by one or more of the following:
- •Angiographic evidence (either invasive or noninvasive) of ≥ 50% stenosis of one or more major coronary arteries
- •History of myocardial infarction (MI) documented by positive creatine kinase-myocardial band (CK-MB) enzymes, troponins, or electrocardiogram (ECG) changes
- •Noninvasive imaging stress test diagnostic of CAD (eg, nuclear perfusion scan, stress echocardiogram, stress cardiac magnetic resonance scan)
- •Stable antianginal treatment with up to 2 antianginal agents
排除标准
- •Inability to exercise or having exercise limitation due to other co-morbidities that may interfere with ability to perform required exercise tolerance testing (ETT)
- •Presence of electrocardiographic or other abnormalities that interfere with ECG interpretation or may cause a false positive stress test
- •History of heart failure as defined by New York Heart Association Class III-IV and/or known left ventricular ejection fraction ≤ 45%
- •History of severe disabling angina as defined by Canadian Cardiovascular Society Class IV
- •Myocardial infarction, acute coronary syndrome or coronary revascularization within 3 months prior to screening, or planned coronary revascularization during the study period
- •Stroke or transient ischemic attack within 6 months prior to screening
- •Chronic persistent atrial fibrillation
- •Uncontrolled hypertension (seated systolic blood pressure (SBP) > 160 mm Hg or diastolic blood pressure (DBP) > 110 mm Hg)
- •Body mass index (BMI) ≥ 36 kg/m^2
研究组 & 干预措施
Placebo
Placebo to match GS-6615 (5 tablets) on Day 1, followed by placebo to match GS-6615 twice daily
干预措施: Placebo (Drug)
GS-6615
GS-6615 30 mg (5 x 6 mg) on Day 1, followed by 6 mg twice daily
干预措施: GS-6615 (Drug)
结局指标
主要结局
Change from baseline in time to 1 mm ST-segment depression
时间窗: Baseline; Day 13 (± 3 days)
For treadmill-related endpoints, baseline is defined as the value derived from the last exercise tolerance testing performed during the qualifying period.
次要结局
- Time to onset of angina during exercise tolerance testing at the end of the double-blind treatment period(Baseline; Day 13 (± 3 days))
- Change from baseline in total exercise duration at the end of the double-blind treatment period(Baseline; Day 13 (± 3 days))