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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
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: 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
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014