Back to resultsClinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument (SYMPHONYext)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Macitentan
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary Arterial Hypertension (PAH), psychometric instrument, PAH-SYMPACT
Eligibility 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
Sites / Locations
- Kentuckiana Pulmonary Associates
- The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Macitentan
Arm Description
Macitentan tablet, dose of 10 mg, once daily.
Outcomes
Primary Outcome Measures
Incident Rate of Adverse Events (AEs).
Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01847014
Brief Title
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
Acronym
SYMPHONYext
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 Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Protocol-defined criterion of macitentan availability achieved.
Study Start Date
September 1, 2013 (Actual)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Pulmonary Arterial Hypertension (PAH), psychometric instrument, PAH-SYMPACT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Macitentan
Arm Type
Experimental
Arm Description
Macitentan tablet, dose of 10 mg, once daily.
Intervention Type
Drug
Intervention Name(s)
Macitentan
Other Intervention Name(s)
ACT-064992
Intervention Description
Macitentan tablet, dose of 10 mg, once daily.
Primary Outcome Measure Information:
Title
Incident Rate of Adverse Events (AEs).
Description
Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.
Time Frame
From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Romero, MD
Organizational Affiliation
Actelion Pharmaceuticals US, Inc
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gary Palmer, MD, MBA
Organizational Affiliation
Actelion Pharmaceuticals US, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
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