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ACT-293987 in Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT01112306
Recruitment Status : Active, not recruiting
First Posted : April 28, 2010
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
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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)

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: ACT-293987 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of Selexipag (ACT-293987) in Patients With Pulmonary Arterial Hypertension
Actual Study Start Date : December 1, 2009
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Selexipag

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
ACT-293987, twice daily
 Drug: ACT-293987
Tablets, twice daily


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who participated to the double-blind study AC-065A302 and either had a morbidity event or had completed the study as scheduled per protocol.
  • Signed informed consent.

Exclusion Criteria:

  • Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in AC-065A302/GRIPHON.
  • Severe hepatic impairment (Child-Pugh C).
  • Females who are pregnant or 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.
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): NCT01112306


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Sponsors and Collaborators
Actelion
Investigators
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Study Director: Aline Frey Actelion
More Information
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01112306     History of Changes
Other Study ID Numbers: AC-065A303
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Keywords provided by Actelion:
Open-label
PAH
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
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Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
 Lung Diseases
Respiratory Tract Diseases
Selexipag
Antihypertensive Agents