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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
  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: 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

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) ]

Enrollment: 4
Study Start Date: September 2013
Estimated Study Completion Date: July 2016
Primary Completion Date: October 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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: Alain Romero, MD Actelion Pharmaceuticals US, Inc
Study Chair: Gary Palmer, MD, MBA Actelion Pharmaceuticals US, Inc.
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01847014     History of Changes
Other Study ID Numbers: AC-055-402
First Submitted: May 2, 2013
First Posted: May 6, 2013
Last Update Posted: October 12, 2017
Last Verified: June 2016

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

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