AC-055-402: An Extension of AC-055-401, Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument (SYMPHONYext)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01847014
First received: May 2, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Macitentan
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Frequency of treatment-emergent adverse events, serious adverse events, marked laboratory abnormalities and adverse events leading to study drug discontinuation from Baseline to Week 16. [ Time Frame: Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug) ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: September 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macitentan
Macitentan tablet, dose of 10 mg, once daily.
Drug: Macitentan
Macitentan tablet, dose of 10 mg, once daily.
Other Name: ACT-064992

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure.
  • Patients with PAH who completed study AC-055-401
  • Women of childbearing potential must:
  • Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests.
  • Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation.

Exclusion Criteria:

  • Patients who prematurely discontinued study drug in study AC-055-401
  • Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study
  • Known hypersensitivity to macitentan or its excipients or drugs of the same class
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01847014

Locations
United States, Kentucky
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
United States, Ohio
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
Sponsors and Collaborators
Actelion
Investigators
Study Chair: Rajiv Patni, MD Actelion Pharmaceuticals US, Inc
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01847014     History of Changes
Other Study ID Numbers: AC-055-402
Study First Received: May 2, 2013
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
Pulmonary Arterial Hypertension (PAH)

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

ClinicalTrials.gov processed this record on April 17, 2014