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

Phase 3TerminatedNCT01847014

Actelion4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

MacitentanDRUG

Macitentan tablet, dose of 10 mg, once daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Kentuckiana Pulmonary Associates

Louisville, Kentucky, United States

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

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).

Data from ClinicalTrials.gov

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