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

Ischemic Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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• Status: Withdrawn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

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

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