GS-6615 in Adults With Chronic Stable Angina and Coronary Artery Disease

NCT ID: NCT02377336

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-08-31

Brief Summary

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.

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GS-6615

GS-6615 30 mg (5 x 6 mg) on Day 1, followed by 6 mg twice daily

Group Type: EXPERIMENTAL

GS-6615

Intervention Type: DRUG

GS-6615 tablets administered orally

Placebo

Placebo to match GS-6615 (5 tablets) on Day 1, followed by placebo to match GS-6615 twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match GS-6615 tablets administered orally

Interventions

GS-6615

GS-6615 tablets administered orally

Intervention Type: DRUG

Placebo

Placebo to match GS-6615 tablets administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Yue, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Other Identifiers

2014-003994-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-279-1503

Identifier Type: -

Identifier Source: org_study_id