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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003457-25 | EudraCT Number |
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Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macitentan | Experimental | Macitentan 10mg, oral tablet, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macitentan | Drug | Macitentan 10mg, oral tablet, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication. | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) |
| Number of Participants With AEs Leading to Study Drug Discontinuation | Number of participants with AEs leading to study drug discontinuation was reported. | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication. | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) |
| Number of Participants With Hemoglobin Abnormalities | Number of participants with hemoglobin abnormalities were reported. It included hemoglobin less than (<) 80 grams per liter (g/L), hemoglobin <100 g/L, hemoglobin greater than or equal to (>=) 80 g/L and <100 g/L, hemoglobin <100g/L and a decrease of >20 g/L from baseline, decrease of >20 g/L in hemoglobin from baseline, decrease of >20 g/L and <=50 g/L in hemoglobin from baseline, and decrease of >50 g/L in hemoglobin from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin McGuire | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leuven | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39520648 | Derived | Kim NH, D'Armini AM, Howard LS, Jenkins DP, Jing ZC, Mayer E, Chamitava L, Lack G, Rofael H, Solonets M, Ghofrani HA. Long-Term Safety and Efficacy of Macitentan in Inoperable Chronic Thromboembolic Pulmonary Hypertension: Results from MERIT and its Open-Label Extension. Pulm Ther. 2025 Mar;11(1):101-116. doi: 10.1007/s41030-024-00276-w. Epub 2024 Nov 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Macitentan 10 Milligrams (mg) | Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2021 | Mar 17, 2023 |
Not provided
Not provided
Not provided
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| Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) |
| Number of Participants With Liver Tests Abnormalities | Number of participants with liver tests abnormalities were reported. It included alanine aminotransferase (ALT) or aspartate aminotransferase (AST): >=3 x Upper limit of the normal range (ULN), >=3 and <5 x ULN, >=5 ULN, and >=5 and <8 x ULN, >= 8 x ULN, and total bilirubin >=2 x ULN. | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) |
| Change From Baseline in Blood Pressure at Month 6 | Change from baseline in blood pressure at Month 6 (both systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was reported. | Baseline and Month 6 |
| Change From Baseline in Pulse Rate at Month 6 | Change from baseline in pulse rate at Month 6 was reported. | Baseline and Month 6 |
| Change From Baseline in Body Weight at Month 6 | Change from baseline in body weight at Month 6 was reported. | Baseline and Month 6 |
| Beijing |
| China |
| Guangzhou | China |
| Shanghai | China |
| Shenyang | China |
| Wuhan | China |
| Prague | Czechia |
| Le Kremlin-Bicêtre | France |
| Paris | France |
| Toulouse | France |
| Giessen | Germany |
| Heidelberg | Germany |
| Würzburg | Germany |
| Budapest | Hungary |
| Debrecen | Hungary |
| Kaunas | Lithuania |
| Mexico City | Mexico |
| Lublin | Poland |
| Wroclaw | Poland |
| Kemerovo | Russia |
| Moscow | Russia |
| Novosibirsk | Russia |
| Saint Petersburg | Russia |
| Tomsk | Russia |
| Zurich | Switzerland |
| Bangkok | Thailand |
| Chiang Mai | Thailand |
| Capa_Istanbul | Turkey (Türkiye) |
| Kyiv | Ukraine |
| Lviv | Ukraine |
| Cambridge | United Kingdom |
| London | United Kingdom |
| Sheffield | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Macitentan 10 Milligrams (mg) | Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication. | Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. | Posted | Count of Participants | Participants | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With AEs Leading to Study Drug Discontinuation | Number of participants with AEs leading to study drug discontinuation was reported. | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. | Posted | Count of Participants | Participants | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication. | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. | Posted | Count of Participants | Participants | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Hemoglobin Abnormalities | Number of participants with hemoglobin abnormalities were reported. It included hemoglobin less than (<) 80 grams per liter (g/L), hemoglobin <100 g/L, hemoglobin greater than or equal to (>=) 80 g/L and <100 g/L, hemoglobin <100g/L and a decrease of >20 g/L from baseline, decrease of >20 g/L in hemoglobin from baseline, decrease of >20 g/L and <=50 g/L in hemoglobin from baseline, and decrease of >50 g/L in hemoglobin from baseline. | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. | Posted | Count of Participants | Participants | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Liver Tests Abnormalities | Number of participants with liver tests abnormalities were reported. It included alanine aminotransferase (ALT) or aspartate aminotransferase (AST): >=3 x Upper limit of the normal range (ULN), >=3 and <5 x ULN, >=5 ULN, and >=5 and <8 x ULN, >= 8 x ULN, and total bilirubin >=2 x ULN. | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. | Posted | Count of Participants | Participants | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) |
|
| |||||||||||||||||||||||||||
| Primary | Change From Baseline in Blood Pressure at Month 6 | Change from baseline in blood pressure at Month 6 (both systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was reported. | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline and Month 6 |
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Pulse Rate at Month 6 | Change from baseline in pulse rate at Month 6 was reported. | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Beats per minute | Baseline and Month 6 |
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Body Weight at Month 6 | Change from baseline in body weight at Month 6 was reported. | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | kilograms (kg) | Baseline and Month 6 |
|
|
Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Macitentan 10 Milligrams (mg) | Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months). | 14 | 76 | 44 | 76 | 67 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Aortic Valve Stenosis | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Atrial Tachycardia | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Right Ventricular Failure | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Arteriovenous Malformation | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Deafness Neurosensory | Ear and labyrinth disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gastric Polyps | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gastrointestinal Motility Disorder | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Large Intestine Polyp | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Peritoneal Adhesions | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Appendiceal Abscess | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pneumonia Parainfluenzae Viral | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pulmonary Tuberculosis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis Chronic | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Streptococcal Sepsis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Chemical Burns of Eye | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Catheterisation Cardiac | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Chest X-Ray Abnormal | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gastric Cancer Stage Iv | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Diplegia | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haemorrhage Intracranial | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Obstructive Airways Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pickwickian Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Angioplasty | Surgical and medical procedures | MedDRA 24.1 | Non-systematic Assessment |
| |
| Arterial Angioplasty | Surgical and medical procedures | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pulmonary Endarterectomy | Surgical and medical procedures | MedDRA 24.1 | Non-systematic Assessment |
| |
| Air Embolism | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Reperfusion Injury | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection Viral | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
Study limitations included the open-label (OL), uncontrolled design, and small sample size.
Any study-related publication written independently by investigators must be submitted to Actelion for review at least 30 days prior to submission for publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientific Leader | Actelion Pharmaceuticals Ltd. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2022 | Mar 17, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C533860 | macitentan |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Participants |
|
|
|
|
|
|
|