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OPsumit USers Registry (OPUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02126943
Recruitment Status : Recruiting
First Posted : April 30, 2014
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
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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 Design
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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 : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Macitentan

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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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

Contacts and Locations
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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
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Actelion
Investigators
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Study Chair: V McLaughlin, MD Chair of the OPUS scientific committee (OSC)
More Information
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02126943    
Other Study ID Numbers: AC-055-503
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Keywords provided by Actelion:
PAH
pulmonary arterial hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Macitentan
 Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists