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ACT-293987 in Pulmonary Arterial Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01112306
First received: April 8, 2010
Last updated: November 11, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Pulmonary Arterial Hypertension
Drug: ACT-293987
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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. ]

Estimated Enrollment: 670
Study Start Date: December 2009
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ACT-293987, twice daily
Drug: ACT-293987
Tablets, twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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: NCT01112306

  Show 155 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Aline Frey Actelion
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01112306     History of Changes
Other Study ID Numbers: AC-065A303
Study First Received: April 8, 2010
Last Updated: November 11, 2016

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

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

ClinicalTrials.gov processed this record on April 21, 2017