A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin
NCT00995566
ABOUT THIS STUDY
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- Evidence of a personally signed and dated informed consent document by the patient indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion.
- Additional inclusion criteria reflect the approved label for Thelin as outlined in the SmPC.
- There are no specific exclusion criteria for enrollment in the Thelin Patient Safety
Registry, with the exception of those reflected in the approved label for Thelin as
outlined in the SmPC.
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Descriptive Information | ||||
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Brief Title | A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin | |||
Official Title | Thelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin | |||
Brief Summary | The Thelin Patient Safety Registry is a post-marketing program in the European Union (EU) that is designed to supplement the reporting of spontaneous adverse events (AE) and better characterize known and potential safety signals for Thelin. The registry is a secure, restricted access, electronic system which collects anonymous, pre-defined, patient-level data on demographic variables, safety monitoring measurements (i.e. liver function tests, haemoglobin and international normalized ratio (INR) measurements), concomitant medications, information on AEs and Thelin drug discontinuation. Regular review of the data is conducted to assess the frequency of identified safety risks and to monitor for the emergence of new safety signals at monthly pharmacovigilance meetings, quarterly signal detection meetings, and for each Periodic Safety Update Report (PSUR). | |||
Detailed Description | Non-probability sample | |||
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 |
| |||
Condition | Pulmonary Arterial Hypertension | |||
Intervention | Drug: Sitaxentan sodium
Please note that this is a non-interventional study and no drug is actually given as an intervention. Instead, patients prescribed THELIN are being followed under real world circumstances. However at the request of the QA group at CT.gov, we were instructed to add sitaxentan sodium as the intervention type, regardless of the fact that this is a non-interventional study. | |||
Study Groups/Cohorts | Thelin Registry Patients
Intervention: Drug: Sitaxentan sodium | |||
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 | Terminated | |||
Actual Enrollment | 54 | |||
Original Estimated Enrollment | 5000 | |||
Actual Study Completion Date | February 2011 | |||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Belgium, France, Germany | |||
Removed Location Countries | Sweden | |||
Administrative Information | ||||
NCT Number | NCT00995566 | |||
Other Study ID Numbers | B1321045 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2011 |