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Protocol-defined criterion of macitentan availability achieved.
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SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macitentan | Experimental | Macitentan tablet, dose of 10 mg, once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macitentan | Drug | Macitentan tablet, dose of 10 mg, once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incident Rate of Adverse Events (AEs). | Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit. | From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Romero, MD | Actelion Pharmaceuticals US, Inc | Study Chair |
| Gary Palmer, MD, MBA | Actelion Pharmaceuticals US, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kentuckiana Pulmonary Associates | Louisville | Kentucky | United States | |||
| The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital |
Subjects who completed the sixteen week treatment of macitentan on the SYMPHONY AC-055-401 clinical trial were eligible to enter this open-label extension study.
All sites activated on the SYMPHONY AC-055-401 clinical trial were invited to participate in this open-label extension study. Due to meeting the study closure milestone, defined as the marketing of Opsumit on 18 OCT 2013, only two sites received activation. Recruitment occurred between Quarter 2 2013 and Quarter 3 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Macitentan | Macitentan tablet, dose of 10 mg, once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Extension Visit |
| |||||||||||||
| Completion of Extension Study |
|
A total of four participants enrolled directly from the parent clinical trial, SYMPHONY AC-055-401 (NCT01841762). There was only one arm associated with the Extension study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Macitentan | Macitentan tablet, dose of 10 mg, once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participant population is Extension Analysis Set, a total of four patients. Age of patients recorded. |
| 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 | Incident Rate of Adverse Events (AEs). | Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit. | Four participants represent the Extension Analysis Set, who transitioned from completion of SYMPHONY AC-055-401 to this open-label extension clinical trial. | Posted | Count of Participants | Participants | From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the 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 | Macitentan | Macitentan tablet, dose of 10 mg, once daily. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease Exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Tsurutani | Actelion Pharmaceuticals US, Inc. | 6508086586 | scott.tsurutani@actelion.com |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C533860 | macitentan |
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| Cincinnati |
| Ohio |
| United States |
| Count of Participants |
| Participants |
|
| Age, Continuous | Participant population is Extension Analysis Set, a total of four patients. Subject's age was captured in the SYMPHONY AC-055-401 Screening visit. | Mean | Full Range | Years |
|
| Sex: Female, Male | Participant population is Extension Analysis Set, a total of four patients. Subject's sex was captured in the SYMPHONY AC-055-401 Screening visit. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Participant population is Extension Analysis Set, a total of four participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Patient population is the Extension Analysis Set (EAS), a total of 4 participants. | Count of Participants | Participants |
|
| Participants |
|
|
| 4 |
| 1 |
| 4 |
| 3 |
| 4 |
| Pulmonary Arterial Hypertension Exacerbation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Pulmonary Hypertension Exacerbation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Right Heart Failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Right Heart Failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pain In Jaw | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Renal Impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease Exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary Arterial Hypertension Exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary Hypertension Exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
|
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. Upon review, Actelion provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information an/or patient rights. Neither the institution nor the investigator should permit publication during such a review period.