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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004429-97 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eleclazine | Experimental | 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. |
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| Placebo | Experimental | Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eleclazine | Drug | Tablet (s) administered orally once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24 | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12 | Baseline to Week 12 | |
| 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. |
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Key Inclusion Criteria:
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:
Screening (baseline) peak VO2 < 80% of predicted for age, sex, and weight
Ability to perform an upright treadmill cardiopulmonary exercise test (CPET)
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Heart Institute | Los Angeles | California | United States | |||
| University of California Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26915375 | Background | 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. |
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264 participants were screened.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Apr 1, 2014 | Aug 24, 2018 |
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| Placebo | Drug | Placebo to match eleclazine administered orally once daily |
|
| Baseline to Week 24 |
| 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. | Baseline to Week 12 |
| Change in Treadmill Exercise Time From Baseline to Week 24 | Treadmill exercise time is the time to peak exercise. | Baseline to Week 24 |
| Change in Treadmill Exercise Time From Baseline to Week 12 | Treadmill exercise time is the time to peak exercise. | Baseline to Week 12 |
| Los Angeles |
| California |
| United States |
| Stanford University | Stanford | California | United States |
| Yale New Haven Hospital | New Haven | Connecticut | United States |
| Athens Regional Medical Center | Athens | Georgia | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States |
| Brigham & Women's Hospital and Harvard Medical School | Boston | Massachusetts | United States |
| Massachusetts General Hospital | Boston | Massachusetts | United States |
| Tufts Medical Center | Boston | Massachusetts | United States |
| Washington University School of Medicine | St Louis | Missouri | United States |
| Morristown Medical Center | Morristown | New Jersey | United States |
| Columbia University Medical Center/ New York Presbyterian | New York | New York | United States |
| NYU School of Medicine Pediatrics | New York | New York | United States |
| Duke Health Center at Southpoint | Durham | North Carolina | United States |
| Oregon Health and Science University | Portland | Oregon | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States |
| St. Thomas Research Institute | Nashville | Tennessee | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | United States |
| Houston Methodist Hospital | Houston | Texas | United States |
| Texas Heart Institute | Houston | Texas | United States |
| UT Southwestern Medical Center | Houston | Texas | United States |
| University of Washington | Seattle | Washington | United States |
| Marshfield Clinic Research Institute | Marshfield | Wisconsin | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | United States |
| The Alfred Hospital | Melbourne | Victoria | Australia |
| Hôpital Européen Georges Pompidou | Paris | France |
| Universitätsklinikum Hamburg Eppendorf | Hamburg | Germany |
| Ein Kerem-Hadassah Medical Organization | Jerusalem | Israel |
| Rabin Medical Center | Petah Tikva | Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Madonna del Soccorso Hospital | San Benedetto del Tronto | Ascoli Piceno | Italy |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | Italy |
| Azienda Ospedaliero Universitaria Di Bologna | Bologna | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | Italy |
| Ospedale San Raffaele S.r.l. | Milan | Italy |
| Azienda Ospedaliera Monaldi | Naples | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Italy |
| Academisch Medisch Centrum Amsterdam | Amsterdam | North Holland | Netherlands |
| Erasmus MC | Rotterdam | Netherlands |
| University Medical Center Utrecht | Utrecht | Netherlands |
| University Hospital of Wales | Cardiff | South Glamergon | United Kingdom |
| Northern General Hospital | Sheffield | Yorkshire | United Kingdom |
Placebo to match eleclazine administered orally for at least 24 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: all randomized participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo | Placebo to match eleclazine administered orally for up to at least 24 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Peak Oxygen Intake (VO2) | Only 85 participants with available data from the placebo arm in safety analysis set were analyzed at baseline. | Mean | Standard Deviation | mL/kg/min |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24 | 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. | Posted | Mean | Standard Deviation | mL/kg/min | Baseline to Week 24 |
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| Secondary | Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | mL/kg/min | Baseline to Week 12 |
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| Secondary | 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | Score | Baseline to Week 24 |
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| Secondary | 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | Score | Baseline to Week 12 |
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| Secondary | Change in Treadmill Exercise Time From Baseline to Week 24 | Treadmill exercise time is the time to peak exercise. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | min | Baseline to Week 24 |
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| Secondary | Change in Treadmill Exercise Time From Baseline to Week 12 | Treadmill exercise time is the time to peak exercise. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | min | Baseline to Week 12 |
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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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 86 | 14 | 86 | 58 | 86 |
| EG001 | Placebo | Placebo to match eleclazine administered orally for at least 24 weeks | 0 | 86 | 16 | 86 | 62 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| SINUS BRADYCARDIA | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPERTROPHIC CARDIOMYOPATHY | Congenital, familial and genetic disorders | MedDRA (19.1) | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA (19.1) | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (19.1) | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
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| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| DEVICE RELATED INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| ENDOCARDITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| POST PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| SCAPULA FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| CARDIAC INDEX DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| CYSTITIS INTERSTITIAL | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
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| URETEROLITHIASIS | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
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| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| CHEST DISCOMFORT | General disorders | MedDRA (19.1) | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA (19.1) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (19.1) | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| HYPOAESTHESIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| PRESYNCOPE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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The totality of the data did not support continuation of the eleclazine development program. So, this study was terminated prior to the end of the double-blind phase, and therefore no participants entered the open-label extension (OLE) period.
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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures & Data Transparency | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_005.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Oct 10, 2014 | Aug 24, 2018 | Prot_006.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Feb 10, 2015 | Aug 24, 2018 | Prot_007.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 3 | Aug 12, 2016 | Aug 24, 2018 | Prot_008.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2017 | Aug 24, 2018 | SAP_009.pdf |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| D009202 | Cardiomyopathies |
| D006984 | Hypertrophy |
| D024741 | Cardiomyopathy, Hypertrophic, Familial |
| D006333 | Heart Failure |
| D000787 | Angina Pectoris |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| ID | Term |
|---|---|
| C000624281 | eleclazine |
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