Long-Term Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension - Full Text View

Sponsored by:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00667823

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 III

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment
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

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 ]

Estimated Enrollment:	525
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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

Show 173 Study Locations

Sponsors and Collaborators

Actelion

Investigators

Study Chair:

Loic Perchenet, PhD

Actelion

More Information

Responsible Party:	Actelion ( Sebastien Roux, MD )
Study ID Numbers:	AC-055-303
Study First Received:	April 24, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00667823
Health Authority:	United States: Food and Drug Administration; 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 Publica de Chile; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; 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 and Social Development 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

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary

Lung Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009