Long-term Extension Study of the SERAPHIN Study, to Assess the 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: September 17, 2014
Last verified: September 2014
  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: ACT-064992
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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:
  • To assess the safety and tolerability of ACT-064992 in patients with symptomatic pulmonary arterial hypertension [ Time Frame: up to 28 days after study drug discontinuation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment-emergent Adverse Events [ Time Frame: up to 28 days after study drug discontinuation ] [ Designated as safety issue: Yes ]
  • Treatment-emergent Serious Adverse Events [ Time Frame: up tp 28 days after study drug discontinuation ] [ Designated as safety issue: Yes ]
  • Adverse Events leading to premature discontinuation [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
  • Occurence of treatment-emergent increase in ALT and/or AST [ Time Frame: up to 28 days after study drug discontinuation ] [ Designated as safety issue: Yes ]
  • Occurence of treatment-emergent hemoglobin abnormality [ Time Frame: up to 28 days after study drug discontinuation ] [ Designated as safety issue: Yes ]

Enrollment: 550
Study Start Date: July 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ACT-064992
Drug: ACT-064992
tablet oral administration, 10 mg dose once daily

  Eligibility

Ages Eligible for Study:   12 Years and older
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, orPatients 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 151 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Chair: Loic Perchenet, PhD Actelion
  More Information

No publications provided

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: September 17, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Ministry for Health and Women
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products Environment
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Taiwan: Department of Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Actelion:
Pulmonary Arterial Hypertension
PAH
SERAPHIN
992

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014