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

NCT ID: NCT01847014

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-01
• Study Completion Date: 2017-11-30

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Macitentan

Macitentan tablet, dose of 10 mg, once daily.

Group Type: EXPERIMENTAL

Macitentan

Intervention Type: DRUG

Macitentan tablet, dose of 10 mg, once daily.

Interventions

Macitentan

Macitentan tablet, dose of 10 mg, once daily.

Intervention Type: DRUG

Other Intervention Names

ACT-064992

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Romero, MD

Role: STUDY_CHAIR

Actelion Pharmaceuticals US, Inc

Gary Palmer, MD, MBA

Role: STUDY_CHAIR

Actelion Pharmaceuticals US, Inc.

Locations

Kentuckiana Pulmonary Associates

Louisville, Kentucky, United States

The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

AC-055-402

Identifier Type: -

Identifier Source: org_study_id