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

This study has been terminated.
(Protocol-defined criterion of macitentan availability achieved.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01847014
First Posted: May 6, 2013
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Actelion
May 2, 2013
May 6, 2013
October 12, 2017
September 2013
October 2015   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT01847014 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: Macitentan
Macitentan tablet, dose of 10 mg, once daily.
Other Name: ACT-064992
Experimental: Macitentan
Macitentan tablet, dose of 10 mg, once daily.
Intervention: Drug: Macitentan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
July 2016
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01847014
AC-055-402
No
Not Provided
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Actelion
Actelion
Not Provided
Study Chair: Alain Romero, MD Actelion Pharmaceuticals US, Inc
Study Chair: Gary Palmer, MD, MBA Actelion Pharmaceuticals US, Inc.
Actelion
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP