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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377336
Recruitment Status : Withdrawn (Anticipated recruitment challenges)
First Posted : March 3, 2015
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Drug: GS-6615 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of GS-6615 in Subjects With Chronic Stable Angina and Coronary Artery Disease
Study Start Date : May 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GS-6615
GS-6615 30 mg (5 x 6 mg) on Day 1, followed by 6 mg twice daily
Drug: GS-6615
GS-6615 tablets administered orally

Placebo Comparator: Placebo
Placebo to match GS-6615 (5 tablets) on Day 1, followed by placebo to match GS-6615 twice daily
Drug: Placebo
Placebo to match GS-6615 tablets administered orally




Primary Outcome Measures :
  1. Change from baseline in time to 1 mm ST-segment depression [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change from baseline in total exercise duration at the end of the double-blind treatment period [ Time Frame: Baseline; Day 13 (± 3 days) ]
  2. Time to onset of angina during exercise tolerance testing at the end of the double-blind treatment period [ Time Frame: Baseline; Day 13 (± 3 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377336


Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Patrick Yue, MD Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02377336    
Other Study ID Numbers: GS-US-279-1503
2014-003994-41 ( EudraCT Number )
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by Gilead Sciences:
GS-6615
coronary heart disease
angina pectoris
late sodium current
myocardial ischemia
coronary artery disease
chronic stable angina
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Angina, Stable
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms