Subjects with symptoms (NYHA Class = II dyspnea or CCS Class = II angina) due to hypertrophic cardiomyopathy (defined by standard criteria as a maximal LV wall thickness of = 15 mm in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed) MedDRA version: 19.0 Level: PT Classification code 10020871 Term: Hypertrophic cardiomyopathy System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Product Name: GS-6615 3 mg White
Product Code: GS-6615 3 mg White
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: No INN or proposed INN available
CAS Number: 1443211-72-0
Current Sponsor
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 2) Males and females 18 to 65 years old, inclusive 3) Established diagnosis of Hypertrophic Cardiomyopathy defined by standard criteria as a maximal LV wall thickness = 15mm at initial diagnosis in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed 4) Exertional symptoms including at least one of the following: a) New York Heart Association (NYHA) Class = II Dyspnea b) Canadian Cardiovascular Society (CCS) Class = II Angina 5) Screening (baseline) Peak VO2 =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 1) Known aortic valve stenosis (moderate or severe) confirmed by echocardiogram 2) Known coronary artery disease (defined as = 50% stenosis in = 1 epicardial coronary artery) 3) Left ventricular systolic dysfunction (ejection fraction 2xULN, or total bilirubin > 1.5xULN 12) Known or suspected history of seizures or epilepsy 13) Use of Class I antiarrhythmic drugs, including disopyramide, within 7 days prior to Screening 14) Use of ranolazine within 7 days prior to Screening 15) Use of concomitant treatment with drugs or products that are strong inhibitors or inducers of CYP3A within 5- half-lives prior to Screening 16) Known hypersensitivity to study drug (GS-6615 or placebo), its metabolites, or formulation excipient 17) Females who are pregnant or breastfeeding. Lactating females must agree to discontinue nursing before the study drug is administered. A negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization visit are required for female subjects of childbearing potential. 18) In the judgment of the investigator, any clinically significant ongoing medical condition that might jeopardize the subject’s safety or interfere with the study, including participation in another investigational drug or investigational device study within the 30 days prior to Screening with potential residual effects that might confound the results of this study 19) Any condition that in the opinion of the investigator would preclude compliance with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effect of GS-6615 on exercise capacity, as measured by Peak VO2 achieved during cardiopulmonary exercise testing (CPET), in subjects with symptomatic hypertrophic cardiomyopathy. ;Secondary Objective: The secondary objectives of this study are to: • Evaluate the safety and tolerability of GS-6615 in subjects with symptomatic hypertrophic cardiomyopathy. • Evaluate the effect of GS-6615 on quality of life as measured by the Minnesota Living With Heart Failure Questionnaire (MLHFQ). • Evaluate the effect of GS-6615 on treadmill exercise time during CPET.;Primary end point(s): The primary efficacy endpoint is the change in Peak VO2 from baseline (Screening) to Week 24.;Timepoint(s) of evaluation of this end point: Monitoring will be conducted on subject in the clinic at Screening and Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are: • Change in MLHFQ from baseline to Week 24. • Change in treadmill exercise time from baseline to Week 24. • Change in Peak VO2 from baseline to Week 12. • Change in the MLHFQ from baseline to Week 12. • Change in treadmill exercise time from baseline to Week 12. The safety endpoints include mortality and appropriate ICD interventions (shock or anti-tachycardia pacing), AEs, vital signs, clinical laboratory tests, and ECG data (PR, RR, QRS, QT and QTc interval).;Timepoint(s) of evaluation of this end point: Monitoring will be conducted on subject in the clinic at Screening, Randomization (Day 1 of the Treatment period), during the treatment period at Week 2, Week 6, Week 12, Week 18, Week 24, and every 12 weeks after Week 24 through End of Double-Blind Treatment visit. | — |
Countries
Australia, France, Germany, Israel, Italy, Netherlands, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd
Outcome results
None listed