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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02377336
Other study ID # GS-US-279-1503
Secondary ID 2014-003994-41
Status Withdrawn
Phase Phase 2
First received February 26, 2015
Last updated June 4, 2015
Start date May 2015
Est. completion date August 2016

Study information

Verified date June 2015
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods AdministrationBulgaria: Bulgarian Drug AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIsrael: Ministry of HealthNew Zealand: Health Research CouncilPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Sweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyRomania: National Agency for Medicines and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
GS-6615
GS-6615 tablets administered orally
Placebo
Placebo to match GS-6615 tablets administered orally

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in time to 1 mm ST-segment depression For treadmill-related endpoints, baseline is defined as the value derived from the last exercise tolerance testing performed during the qualifying period. Baseline; Day 13 (± 3 days) No
Secondary Change from baseline in total exercise duration at the end of the double-blind treatment period Baseline; Day 13 (± 3 days) No
Secondary Time to onset of angina during exercise tolerance testing at the end of the double-blind treatment period Baseline; Day 13 (± 3 days) No
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