ACT-293987 in Pulmonary Arterial Hypertension

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Actelion

ClinicalTrials.gov Identifier:

NCT01112306

First received: April 8, 2010

Last updated: April 25, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 8, 2010

Last Updated Date

April 25, 2013

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to end of study. The duration of the study will be country-dependent and based on the results of the AC-065A302 study. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01112306 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ACT-293987 in Pulmonary Arterial Hypertension

Official Title ^ICMJE

Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension

Brief Summary

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Arterial Hypertension

Intervention ^ICMJE

Drug: ACT-293987

tablets, twice daily

Study Arm (s)

Experimental: 1

ACT-293987, twice daily

Intervention: Drug: ACT-293987

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

670

Estimated Completion Date

February 2015

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients who have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study), or who have experienced a clinical worsening of PAH (adjudicated by the CEC) during study AC-065A302.
Signed informed consent

Exclusion Criteria:

Any major violation of protocol AC-065A302.
Females who plan to become pregnant during the study, or are breastfeeding.
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-293987 or any of the excipients.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Austria, Belarus, Belgium, Chile, China, Colombia, Czech Republic, Denmark, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Malaysia, Mexico, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT01112306

Other Study ID Numbers ^ICMJE

AC-065A303

Has Data Monitoring Committee

Responsible Party

Actelion

Study Sponsor ^ICMJE

Actelion

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Aline Frey

Actelion

Information Provided By

Actelion

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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