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

NCT01847014 | Terminated Phase 3 Results

• 1 other identifier: AC-055-402
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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

Keywords

Pulmonary Arterial Hypertension (PAH); psychometric instrument; PAH-SYMPACT

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

Macitentan

EXPERIMENTAL

Macitentan tablet, dose of 10 mg, once daily.

Drug: Macitentan

Interventions

Macitentan DRUG

Macitentan tablet, dose of 10 mg, once daily.

Also known as: ACT-064992

Macitentan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Actelion: lead

Study Sites (2)

Kentuckiana Pulmonary Associates

Louisville, Kentucky, United States

Location

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

Cincinnati, Ohio, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

macitentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Scott Tsurutani
• Organization: Actelion Pharmaceuticals US, Inc.

scott.tsurutani@actelion.com

6508086586

Study Officials

• Alain Romero, MD

  Actelion Pharmaceuticals US, Inc

  STUDY CHAIR

• Gary Palmer, MD, MBA

  Actelion Pharmaceuticals US, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 6, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: November 30, 2017
• Last Updated: August 22, 2018
• Results First Posted: August 22, 2018

Record last verified: 2018-06

Locations

US (2)