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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
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: N/A
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
Actual Primary Completion Date : December 7, 2020
Actual Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Macitentan

Arms and Interventions
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Arm Intervention/treatment
Experimental: ACT-064992
ACT-064992
 Drug: Macitentan
Tablet, oral administration, 10 mg dose once daily
Other Name: ACT-064992


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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

  3. 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


Eligibility Criteria
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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.
Contacts and Locations
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: January 29, 2021
Last Verified: January 2021
Keywords provided by Actelion:
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