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Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States (OrPHeUS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03197688
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Other: Notapplicable

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Study Type : Observational
Actual Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
Actual Study Start Date : August 3, 2017
Actual Primary Completion Date : September 6, 2018
Actual Study Completion Date : September 6, 2018


Group/Cohort Intervention/treatment
Notapplicable
Not applicable as non-interventional study
Other: Notapplicable
Not applicable as non-interventional study




Primary Outcome Measures :
  1. Estimation of incidence rates of adverse events [ Time Frame: Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 ]
    Incidence rates of liver test abnormalities, Occurrence of Hepatic Adverse Events (HAEs), Occurrence of any other Adverse Event (AE), Occurrence and reason for discontinuation of Opsumit treatment, hospitalization and death


Secondary Outcome Measures :
  1. Description of demographic characteristics of patients [ Time Frame: Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 ]
    To describe demographic characteristics of patients treated with Opsumit at beginning and during study time period

  2. Description of clinical characteristics of patients [ Time Frame: Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018 ]
    To describe clinical characteristics of patients treated with Opsumit at beginning and during study time period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 who initiated Opsumit for the first time between 19 October 2013 and 31 December 2016 (inclusive) are eligible for OrPHeUS (i.e., eligibility period).
Criteria

Inclusion Criteria:

  • Patients who initiated Opsumit for the first time between 19 October 2013 and 31 December 2016 (inclusive)
  • Patients whose medical charts are available for data collection

Exclusion Criteria:

  • Patient participation in the OPUS registry
  • Patient participation in any clinical trial involving Opsumit treatment or macitentan investigational product

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): NCT03197688


Locations
Show Show 106 study locations
Sponsors and Collaborators
Actelion

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT03197688    
Other Study ID Numbers: AC-055-510
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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