Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension (SERAPHIN OL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00667823
First received: April 24, 2008
Last updated: July 4, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Pulmonary Arterial Hypertension
Drug: Macitentan
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Actelion:

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    > 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 ] [ Designated as safety issue: Yes ]
    ≤ 8 g/dL; > 8 and ≤ 10 g/dL


Enrollment: 550
Study Start Date: October 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACT-064992
ACT-064992
Drug: Macitentan
Tablet, oral administration, 10 mg dose once daily
Other Name: ACT-064992

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667823

  Show 136 Study Locations
Sponsors and Collaborators
Actelion
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00667823     History of Changes
Other Study ID Numbers: AC-055-303 
Study First Received: April 24, 2008
Last Updated: July 4, 2016
Health Authority: United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
Slovakia: State Institute for Drug Control
Finland: Finnish Medicines Agency
Russia: Ministry of Health of the Russian Federation
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council
Austria: Federal Ministry for Health and Women
Ukraine: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Mexico: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Israel: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Belarus: Ministry of Health
Taiwan: Department of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

Keywords provided by Actelion:
SERAPHIN
Pulmonary Arterial Hypertension
ACT-064992

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary 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

ClinicalTrials.gov processed this record on August 30, 2016