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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02291237




Registration number
NCT02291237
Ethics application status
Date submitted
11/11/2014
Date registered
14/11/2014
Date last updated
24/09/2018

Titles & IDs
Public title
Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
Scientific title
Study Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
Secondary ID [1] 0 0
2013-004429-97
Secondary ID [2] 0 0
GS-US-361-1157
Universal Trial Number (UTN)
Trial acronym
LIBERTY-HCM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic Cardiomyopathy 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eleclazine
Treatment: Drugs - Placebo

Experimental: Eleclazine - Eleclazine 30 mg single loading dose followed by 3 mg daily maintenance dose up until Week 12, then 6 mg daily maintenance dose from Week 12 at least Week 24, followed by eleclazine 6 mg in an open-label extension period.

Experimental: Placebo - Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period.


Treatment: Drugs: Eleclazine
Tablet (s) administered orally once daily

Treatment: Drugs: Placebo
Placebo to match eleclazine administered orally once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24 - The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.
Timepoint [2] 0 0
Baseline to Week 24
Secondary outcome [3] 0 0
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12 - The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Change in Treadmill Exercise Time From Baseline to Week 24 - Treadmill exercise time is the time to peak exercise.
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [5] 0 0
Change in Treadmill Exercise Time From Baseline to Week 12 - Treadmill exercise time is the time to peak exercise.
Timepoint [5] 0 0
Baseline to Week 12

Eligibility
Key inclusion criteria
Key

- Established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as a
maximal left ventricular wall thickness = 15 mm at initial diagnosis

- Exertional symptoms including at least one of the following:

- New York Heart Association (NYHA) Class = II dyspnea

- Canadian Cardiovascular Society (CCS) Class = II angina

- Screening (baseline) peak VO2 < 80% of predicted for age, sex, and weight

- Ability to perform an upright treadmill cardiopulmonary exercise test (CPET)

Key
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known aortic valve stenosis (moderate or severe)

- Known coronary artery disease

- Left ventricular systolic dysfunction (ejection fraction < 50%)

- Recent septal reduction procedure (ie, surgical myectomy or alcohol septal ablation)
within six months prior to screening or such a procedure scheduled to occur during the
study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
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United States of America
State/province [11] 0 0
Oregon
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United States of America
State/province [12] 0 0
Pennsylvania
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United States of America
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Tennessee
Country [14] 0 0
United States of America
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Texas
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United States of America
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Washington
Country [16] 0 0
United States of America
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Wisconsin
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France
State/province [17] 0 0
Paris
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Germany
State/province [18] 0 0
Hamburg
Country [19] 0 0
Israel
State/province [19] 0 0
Jerusalem
Country [20] 0 0
Israel
State/province [20] 0 0
Petah Tikva
Country [21] 0 0
Israel
State/province [21] 0 0
Ramat-Gan
Country [22] 0 0
Israel
State/province [22] 0 0
Tel Aviv
Country [23] 0 0
Italy
State/province [23] 0 0
Ascoli Piceno
Country [24] 0 0
Italy
State/province [24] 0 0
Bergamo
Country [25] 0 0
Italy
State/province [25] 0 0
Bologna
Country [26] 0 0
Italy
State/province [26] 0 0
Florence
Country [27] 0 0
Italy
State/province [27] 0 0
Milan
Country [28] 0 0
Italy
State/province [28] 0 0
Naples
Country [29] 0 0
Italy
State/province [29] 0 0
Parma
Country [30] 0 0
Italy
State/province [30] 0 0
Rome
Country [31] 0 0
Netherlands
State/province [31] 0 0
Noord-Holland
Country [32] 0 0
Netherlands
State/province [32] 0 0
Rotterdam
Country [33] 0 0
Netherlands
State/province [33] 0 0
Utrecht
Country [34] 0 0
United Kingdom
State/province [34] 0 0
South Glamergon
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on
exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary
exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).
Trial website
https://clinicaltrials.gov/show/NCT02291237
Trial related presentations / publications
Olivotto I, Hellawell JL, Farzaneh-Far R, Blair C, Coppini R, Myers J, Belardinelli L, Maron MS. Novel Approach Targeting the Complex Pathophysiology of Hypertrophic Cardiomyopathy: The Impact of Late Sodium Current Inhibition on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy (LIBERTY-HCM) Trial. Circ Heart Fail. 2016 Mar;9(3):e002764. doi: 10.1161/CIRCHEARTFAILURE.115.002764.
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02291237