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Trial record 1 of 2 for:    OPUS Macitentan
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OPsumit USers Registry (OPUS)

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ClinicalTrials.gov Identifier: NCT02126943
Recruitment Status : Recruiting
First Posted : April 30, 2014
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: Opsumit (macitentan)

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
Actual Study Start Date : April 30, 2014
Estimated Primary Completion Date : October 17, 2018
Estimated Study Completion Date : October 17, 2018


Group/Cohort Intervention/treatment
Opsumit (macitentan)
10 mg tablets
Drug: Opsumit (macitentan)
10 mg tablets
Other Name: ACT-064992



Primary Outcome Measures :
  1. To estimate incidence rates for specified outcomes. [ Time Frame: 1 year ]
    Liver test abnormalities/ Occurrence of Hepatic Adverse Events (HAEs)/ Occurrence of any other AEs/ Discontinuation of Opsumit and reason for stopping therapy/ Hospitalization and death.


Secondary Outcome Measures :
  1. To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period. [ Time Frame: 1 year ]

Other Outcome Measures:
  1. To describe PAH treatment patterns at enrollment and during observation period. [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients newly treated with Opsumit
Criteria

Inclusion Criteria:

Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.

Signed ICF

Exclusion Criteria:

Previous user of Opsumit defined as patient who initiated therapy >30 days prior to enrollment.

Patients enrolled in any ongoing clinical trials


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): NCT02126943


Contacts
Contact: CTD Clinical Trials Disclosure Desk clinical-trials-disclosure@actelion.com

  Show 156 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Chair: V McLaughlin, MD Chair of the OPUS scientific committee (OSC)

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02126943     History of Changes
Other Study ID Numbers: AC-055-503
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Keywords provided by Actelion:
PAH
pulmonary arterial hypertension

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