Trial Outcomes & Findings for Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy (NCT NCT02291237)
NCT ID: NCT02291237
Last Updated: 2018-09-24
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
172 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2018-09-24
Participant Flow
Participants were enrolled at study sites in Asia, Australia, Europe and North America. The first participant was screened on 05 February 2015. The last study visit occurred on 22 February 2017.
264 participants were screened.
Participant milestones
| Measure |
Eleclazine 30/3/6 mg
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
Placebo to match eleclazine administered orally for at least 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
86
|
86
|
Reasons for withdrawal
| Measure |
Eleclazine 30/3/6 mg
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
Placebo to match eleclazine administered orally for at least 24 weeks
|
|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
72
|
67
|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Investigator's Discretion
|
0
|
3
|
|
Overall Study
Withdrew Consent
|
11
|
11
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Subject Required Prohibited Medication
|
2
|
0
|
Baseline Characteristics
Only 85 participants with available data from the placebo arm in safety analysis set were analyzed at baseline.
Baseline characteristics by cohort
| Measure |
Eleclazine 30/3/6 mg
n=86 Participants
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
n=86 Participants
Placebo to match eleclazine administered orally for up to at least 24 weeks
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 11.7 • n=86 Participants
|
48 years
STANDARD_DEVIATION 10.3 • n=86 Participants
|
47 years
STANDARD_DEVIATION 11.1 • n=172 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=86 Participants
|
36 Participants
n=86 Participants
|
73 Participants
n=172 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=86 Participants
|
50 Participants
n=86 Participants
|
99 Participants
n=172 Participants
|
|
Race/Ethnicity, Customized
White
|
74 Participants
n=86 Participants
|
73 Participants
n=86 Participants
|
147 Participants
n=172 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=86 Participants
|
3 Participants
n=86 Participants
|
10 Participants
n=172 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=86 Participants
|
7 Participants
n=86 Participants
|
9 Participants
n=172 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=86 Participants
|
1 Participants
n=86 Participants
|
3 Participants
n=172 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
0 Participants
n=86 Participants
|
2 Participants
n=86 Participants
|
2 Participants
n=172 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=86 Participants
|
0 Participants
n=86 Participants
|
1 Participants
n=172 Participants
|
|
Race/Ethnicity, Customized
Hispanic Or Latino
|
11 Participants
n=86 Participants
|
9 Participants
n=86 Participants
|
20 Participants
n=172 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic Or Latino
|
75 Participants
n=86 Participants
|
75 Participants
n=86 Participants
|
150 Participants
n=172 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=86 Participants
|
54 participants
n=86 Participants
|
109 participants
n=172 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=86 Participants
|
1 participants
n=86 Participants
|
2 participants
n=172 Participants
|
|
Region of Enrollment
France
|
3 participants
n=86 Participants
|
5 participants
n=86 Participants
|
8 participants
n=172 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=86 Participants
|
2 participants
n=86 Participants
|
4 participants
n=172 Participants
|
|
Region of Enrollment
Israel
|
8 participants
n=86 Participants
|
6 participants
n=86 Participants
|
14 participants
n=172 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=86 Participants
|
13 participants
n=86 Participants
|
25 participants
n=172 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=86 Participants
|
5 participants
n=86 Participants
|
7 participants
n=172 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=86 Participants
|
0 participants
n=86 Participants
|
3 participants
n=172 Participants
|
|
Peak Oxygen Intake (VO2)
|
19.06 mL/kg/min
STANDARD_DEVIATION 4.853 • n=86 Participants • Only 85 participants with available data from the placebo arm in safety analysis set were analyzed at baseline.
|
19.88 mL/kg/min
STANDARD_DEVIATION 4.645 • n=85 Participants • Only 85 participants with available data from the placebo arm in safety analysis set were analyzed at baseline.
|
19.47 mL/kg/min
STANDARD_DEVIATION 4.755 • n=171 Participants • Only 85 participants with available data from the placebo arm in safety analysis set were analyzed at baseline.
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Eleclazine 30/3/6 mg
n=73 Participants
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
n=68 Participants
Placebo to match eleclazine administered orally for at least 24 weeks
|
|---|---|---|
|
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24
|
0.15 mL/kg/min
Standard Deviation 4.312
|
0.48 mL/kg/min
Standard Deviation 4.143
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Eleclazine 30/3/6 mg
n=83 Participants
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
n=78 Participants
Placebo to match eleclazine administered orally for at least 24 weeks
|
|---|---|---|
|
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12
|
0.28 mL/kg/min
Standard Deviation 4.028
|
0.57 mL/kg/min
Standard Deviation 4.314
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Eleclazine 30/3/6 mg
n=86 Participants
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
n=86 Participants
Placebo to match eleclazine administered orally for at least 24 weeks
|
|---|---|---|
|
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24
Baseline
|
40.22 Score
Standard Deviation 25.544
|
38.80 Score
Standard Deviation 23.177
|
|
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24
Change from Baseline at Week 24
|
-4.05 Score
Standard Deviation 15.164
|
-5.57 Score
Standard Deviation 14.345
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Eleclazine 30/3/6 mg
n=86 Participants
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
n=86 Participants
Placebo to match eleclazine administered orally for at least 24 weeks
|
|---|---|---|
|
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12
Baseline
|
40.22 Score
Standard Deviation 25.544
|
38.80 Score
Standard Deviation 23.177
|
|
Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12
Change at Week 12
|
-3.84 Score
Standard Deviation 15.654
|
-3.40 Score
Standard Deviation 13.780
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Treadmill exercise time is the time to peak exercise.
Outcome measures
| Measure |
Eleclazine 30/3/6 mg
n=86 Participants
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
n=86 Participants
Placebo to match eleclazine administered orally for at least 24 weeks
|
|---|---|---|
|
Change in Treadmill Exercise Time From Baseline to Week 24
Baseline
|
12.88 min
Standard Deviation 4.641
|
13.60 min
Standard Deviation 4.317
|
|
Change in Treadmill Exercise Time From Baseline to Week 24
Change from Baseline at Week 24
|
0.27 min
Standard Deviation 3.954
|
0.24 min
Standard Deviation 3.208
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Treadmill exercise time is the time to peak exercise.
Outcome measures
| Measure |
Eleclazine 30/3/6 mg
n=86 Participants
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
n=86 Participants
Placebo to match eleclazine administered orally for at least 24 weeks
|
|---|---|---|
|
Change in Treadmill Exercise Time From Baseline to Week 12
Baseline
|
12.88 min
Standard Deviation 4.641
|
13.60 min
Standard Deviation 4.317
|
|
Change in Treadmill Exercise Time From Baseline to Week 12
Change from Baseline at Week 12
|
0.48 min
Standard Deviation 3.295
|
0.38 min
Standard Deviation 3.030
|
Adverse Events
Eleclazine 30/3/6 mg
Serious events: 14 serious events
Other events: 58 other events
Deaths: 0 deaths
Placebo
Serious events: 16 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eleclazine 30/3/6 mg
n=86 participants at risk
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
n=86 participants at risk
Placebo to match eleclazine administered orally for at least 24 weeks
|
|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.3%
2/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Cardiac disorders
ATRIAL FLUTTER
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
2.3%
2/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
3.5%
3/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Congenital, familial and genetic disorders
HYPERTROPHIC CARDIOMYOPATHY
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
General disorders
CHEST PAIN
|
2.3%
2/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
2.3%
2/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
2.3%
2/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
ENDOCARDITIS
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
GASTROENTERITIS
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
INFLUENZA
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
PNEUMONIA
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
SCAPULA FRACTURE
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Investigations
CARDIAC INDEX DECREASED
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Renal and urinary disorders
CYSTITIS INTERSTITIAL
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Renal and urinary disorders
URETEROLITHIASIS
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
Other adverse events
| Measure |
Eleclazine 30/3/6 mg
n=86 participants at risk
Single loading dose of eleclazine 30 mg (5 x 6 mg tablets) on Day 1, followed by 3 mg (1 x 3 mg tablet) daily maintenance dose until Week 12, then 6 mg (2 x 3 mg tablets) daily maintenance dose from Week 12 to at least Week 24
|
Placebo
n=86 participants at risk
Placebo to match eleclazine administered orally for at least 24 weeks
|
|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
7.0%
6/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Cardiac disorders
PALPITATIONS
|
10.5%
9/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
12.8%
11/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
2.3%
2/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
5.8%
5/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
NAUSEA
|
12.8%
11/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
12.8%
11/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
General disorders
CHEST DISCOMFORT
|
7.0%
6/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
3.5%
3/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
General disorders
CHEST PAIN
|
12.8%
11/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
10.5%
9/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
General disorders
FATIGUE
|
10.5%
9/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
8.1%
7/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
BRONCHITIS
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
5.8%
5/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
INFLUENZA
|
3.5%
3/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
5.8%
5/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.8%
5/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
12.8%
11/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
8.1%
7/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
11.6%
10/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.7%
4/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
8.1%
7/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.5%
9/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
7.0%
6/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
5.8%
5/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
7.0%
6/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
5.8%
5/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Nervous system disorders
DIZZINESS
|
14.0%
12/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
16.3%
14/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Nervous system disorders
HEADACHE
|
12.8%
11/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
12.8%
11/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Nervous system disorders
HYPOAESTHESIA
|
1.2%
1/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
5.8%
5/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Nervous system disorders
PRESYNCOPE
|
5.8%
5/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
9.3%
8/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
ANXIETY
|
5.8%
5/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
2.3%
2/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.1%
7/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
5.8%
5/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
18.6%
16/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
9.3%
8/86 • Baseline up to the last dose date plus 30 days (maximum exposure: 668 days)
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
|
Additional Information
Clinical Trial Disclosures & Data Transparency
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER