Trial record 1 of 1 for:
NCT00667823
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension (SERAPHIN OL)
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| ClinicalTrials.gov Identifier: NCT00667823 |
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Recruitment Status :
Active, not recruiting
First Posted : April 28, 2008
Last Update Posted : September 4, 2019
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Sponsor:
Actelion
Information provided by (Responsible Party):
Actelion
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Brief Summary:
The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Arterial Hypertension | Drug: Macitentan | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 550 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension |
| Actual Study Start Date : | October 17, 2008 |
| Estimated Primary Completion Date : | September 15, 2021 |
| Estimated Study Completion Date : | September 15, 2021 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Macitentan
| Arm | Intervention/treatment |
|---|---|
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Experimental: ACT-064992
ACT-064992
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Drug: Macitentan
Tablet, oral administration, 10 mg dose once daily
Other Name: ACT-064992 |
Primary Outcome Measures :
- Number of subjects with treatment-emergent Adverse Events (AEs) and serious AEs [ Time Frame: up to 28 days after study drug discontinuation, assessed for up to 55 months ]
Secondary Outcome Measures :
- Number of subjects with AEs leading to premature discontinuation of study drug [ Time Frame: up to 28 days after study drug discontinuation, assessed for up to 55 months ]
- Occurrence of treatment-emergent liver function test (ALT and/or AST) abnormality [ Time Frame: up to 28 days after study drug discontinuation, assessed for up to 55 months ]> 3 and ≤ 5 × ULN; > 5 and ≤ 8 × ULN; > 8 × ULN
- Occurence of treatment-emergent hemoglobin abnormality [ Time Frame: up to 28 days after study drug discontinuation, assessed for up to 55 months ]≤ 8 g/dL; > 8 and ≤ 10 g/dL
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed informed consent prior to initiation of any study-mandated procedure.
- Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
- Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.
Exclusion Criteria:
- Any major violation of protocol AC 055 302/SERAPHIN.
- Pregnancy or breast-feeding.
- AST and/or ALT > 3 times the upper limit of the normal range.
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
- Known hypersensitivity to ACT 064992 or any of the excipients.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667823
Locations
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Sponsors and Collaborators
Actelion
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Actelion |
| ClinicalTrials.gov Identifier: | NCT00667823 |
| Other Study ID Numbers: |
AC-055-303 |
| First Posted: | April 28, 2008 Key Record Dates |
| Last Update Posted: | September 4, 2019 |
| Last Verified: | September 2019 |
Keywords provided by Actelion:
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SERAPHIN Pulmonary Arterial Hypertension ACT-064992 |
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases |
Respiratory Tract Diseases Macitentan Endothelin A Receptor Antagonists Endothelin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Endothelin B Receptor Antagonists |