Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument (SYMPHONYext)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01847014
Recruitment Status : Terminated (Protocol-defined criterion of macitentan availability achieved.)
First Posted : May 6, 2013
Last Update Posted : June 9, 2016
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Macitentan Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2013
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Macitentan
Macitentan tablet, dose of 10 mg, once daily.
Drug: Macitentan
Macitentan tablet, dose of 10 mg, once daily.
Other Name: ACT-064992

Primary Outcome Measures :
  1. 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) ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01847014

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
Study Chair: Alain Romero, MD Actelion Pharmaceuticals US, Inc
Study Chair: Gary Palmer, MD, MBA Actelion Pharmaceuticals US, Inc.

Responsible Party: Actelion Identifier: NCT01847014     History of Changes
Other Study ID Numbers: AC-055-402
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016

Keywords provided by Actelion:
Pulmonary Arterial Hypertension (PAH)
psychometric instrument

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists