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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02126943
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Actelion

Tracking Information
First Submitted Date April 29, 2014
First Posted Date April 30, 2014
Last Update Posted Date August 13, 2020
Actual Study Start Date April 30, 2014
Actual Primary Completion Date April 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 29, 2014)
To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period. [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 29, 2014)
To describe PAH treatment patterns at enrollment and during observation period. [ Time Frame: 1 year ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title OPsumit USers Registry
Official Title US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients newly treated with Opsumit
Condition Pulmonary Arterial Hypertension
Intervention Drug: Opsumit (macitentan)
10 mg tablets
Other Name: ACT-064992
Study Groups/Cohorts Opsumit (macitentan)
10 mg tablets
Intervention: Drug: Opsumit (macitentan)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 12, 2020)
2686
Original Estimated Enrollment
 (submitted: April 29, 2014)
5000
Actual Study Completion Date April 24, 2020
Actual Primary Completion Date April 24, 2020   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02126943
Other Study ID Numbers AC-055-503
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Actelion
Study Sponsor Actelion
Collaborators Not Provided
Investigators
Study Chair: V McLaughlin, MD Chair of the OPUS scientific committee (OSC)
PRS Account Actelion
Verification Date August 2020