Pulmonary Arterial HypertensionNCT01445873
Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
An observational study of Pulmonary Arterial Hypertension, run by Pfizer.
Trial summary
The objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings; to pilot test these methods at three study centers in Europe; and to refine and finalize research methods and corresponding materials for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Sitaxentan sodium
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2009to 28 Mar 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Pulmonary Arterial Hypertension (PAH) (Idiopathic or secondary to connective tissue disease), receiving sitaxentan sodium (Thelin) for treatment of their PAH for at least 6 months.
Who may be able to join
- Idiopathic PAH, or PAH secondary to connective tissue disease
- Receipt of Thelin for treatment of PAH
- 6 months of follow-up (except in the event of death) subsequent to initial receipt of Thelin
- Minimum of one clinic visit documented in the medical record during the 6-month period subsequent to initial receipt of Thelin
Who cannot join
- Participation in any investigational study of Thelin or any other medication for the treatment of PAH during the period beginning 6 months prior to initial receipt of Thelin and ending 6 months subsequent to such receipt
- Receipt of Thelin prior to January 11, 2005 (i.e., the date following the last day on which patients could be enrolled in double-blind treatment in STRIDE-1, STRIDE-2, and/or STRIDE-6); or
- Known contraindications to Thelin therapy (i.e., known hypersensitivity to sitaxsentan or any of its excipients; mild-to-severe hepatic impairment [Child-Pugh Class A-C]; elevated aminotransferases prior to initiation of treatment, defined as aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 times upper limit of normal [ULN]; concomitant use of cyclosporin A; lactation)
About this study
Official title: NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
The objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings; to pilot test these methods at three study centers in Europe; and to refine and finalize research methods and corresponding materials for possible use in a follow-on, full-scale examination of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings.
Read the detailed description
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Sitaxentan sodium
- Keywords
- Pulmonary arterial hypertension, sitaxentan sodium, Thelin
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitaxentan sodiumDrug
Sitaxentan sodium 100 mg / day
| Study group | Role | What they receive |
|---|---|---|
| PAH patients receiving Sitaxentan | Not described Receives: Drug: Sitaxentan sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation
Participants still receiving Thelin with evidence of receipt of another PAH-related therapy (eg. bosentan, sildenafil) not previously received during the study period. Mean time in months to therapy augmentation.
Measured: Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching
Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.
Measured: Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation
Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.
Measured: Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration
Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.
Measured: Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed
Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.
Measured: Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage
Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.
Measured: Day 1 to Month 6
Secondary outcomes (19)
Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications
Use of PAH-related medications other than Thelin described by class of agent received.
Measured: Day 1 to Month 6
Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension
Class I: no limitation of usual (usl) physical activity (PA); PA does not increase(d) (incr) dyspnea (dys), fatigue (ftg), chest pain (CP), or syncope (syn); Class II: mild limitation of usl PA; no discomfort at rest, but normal PA causes incr dys, ftg, CP, or presyncope (presyn); Class III: marked limitation of PA; no discomfort at rest but < ordinary activity causes incr dys, ftg, CP, or presyn; Class IV: unable to perform any PA at rest; may have signs of right ventricular failure; sys and/or ftg at rest and symptoms are incr by almost any PA.
Measured: Baseline to Month 6
Change From Baseline in Mean Right Atrial Pressure
Difference between pre-index and follow-up value.
Measured: Baseline to Month 6
Change From Baseline in Mean Pulmonary Artery Pressure
Difference between pre-index and follow-up value.
Measured: Baseline to Month 6
Change From Baseline in Pulmonary Capillary Wedge Pressure
Difference between pre-index and follow-up value.
Measured: Baseline to Month 6
Change From Baseline in Left Ventricular End Diastolic Pressure
Difference between pre-index and follow-up value.
Measured: Baseline to Month 6
Change From Baseline in Pulmonary Vascular Resistance
Difference between pre-index and follow-up value.
Measured: Baseline to Month 6
Change From Baseline in Cardiac Output
Difference between pre-index and follow-up value.
Measured: Baseline to Month 6
Change From Baseline in Tei Index
Difference between pre-index and follow-up value. Combined myocardial performance index calculated by adding isovolumic contraction time and isovolumic relaxation time and dividing the resulting sum by ejection time.
Measured: Baseline to Month 6
Change From Baseline in Tricuspid Regurgitant Velocity
Difference between pre-index and follow-up value.
Measured: Baseline to Month 6
Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)
6MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Difference between pre-index and follow-up value.
Measured: Baseline to Month 6
Change From Baseline in Borg Dyspnoea Score
Borg dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum). Difference between pre-index and follow-up value.
Measured: Baseline to Month 6
Change From Baseline in Percent of Predicted Peak VO2
Difference between pre-index and follow-up value.
Measured: Baseline to Month 6
Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening
Occurrence of any of the following: death, unplanned PAH-related hospitalization, initiation of epoprostenol, arterial septostomy, lung or heart/lung transplantation, ≥15% decrease from baseline in 6 minute walk test, signs/symptoms of right sided heart failure, and/or worsening WHO functional class.
Measured: Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality
Number of participants who died during the follow-up period.
Measured: Day 1 to Month 6
Number of Hospitalizations
All hospitalizations during the follow-up period recorded in medical records.
Measured: Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation
Number of participants who received an lung transplant during hospitalization.
Measured: Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation
Number of participants who received an heart/lung transplant during hospitalization.
Measured: Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy
Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.
Measured: Day 1 to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study start1 Dec 2009
- Primary completion28 Mar 2011
- Study completion28 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445873
- Sponsor's protocol ID
- B1321051
- Status last verified
- Aug 2020
- First submitted
- 30 Sep 2011
- Last updated
- 1 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
- ClinicalTrials.gov ID
- NCT01445873
- Acronym / sponsor ID
- B1321051
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary arterial hypertension, sitaxentan sodium, Thelin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2009 (actual)
- Primary completion
- 28 Mar 2011 (actual)
- Study completion
- 28 Mar 2011 (actual)
- First posted
- 4 Oct 2011 (estimated)
- Results
- Posted 8 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings; to pilot test these methods at three study centers in Europe; and to refine and finalize research methods and corresponding materials for possible use in a follow-on, full-scale examination of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings.
Detailed description
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAH patients receiving Sitaxentan | – | Drug: Sitaxentan sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Pulmonary Arterial Hypertension (PAH) (Idiopathic or secondary to connective tissue disease), receiving sitaxentan sodium (Thelin) for treatment of their PAH for at least 6 months.
Key inclusion criteria (4 listed)
- Idiopathic PAH, or PAH secondary to connective tissue disease
- Receipt of Thelin for treatment of PAH
- 6 months of follow-up (except in the event of death) subsequent to initial receipt of Thelin
- Minimum of one clinic visit documented in the medical record during the 6-month period subsequent to initial receipt of Thelin
Key exclusion criteria (3 listed)
- Participation in any investigational study of Thelin or any other medication for the treatment of PAH during the period beginning 6 months prior to initial receipt of Thelin and ending 6 months subsequent to such receipt
- Receipt of Thelin prior to January 11, 2005 (i.e., the date following the last day on which patients could be enrolled in double-blind treatment in STRIDE-1, STRIDE-2, and/or STRIDE-6); or
- Known contraindications to Thelin therapy (i.e., known hypersensitivity to sitaxsentan or any of its excipients; mild-to-severe hepatic impairment [Child-Pugh Class A-C]; elevated aminotransferases prior to initiation of treatment, defined as aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 times upper limit of normal [ULN]; concomitant use of cyclosporin A; lactation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitaxentan sodiumSitaxentan sodium 100 mg / day | Drug | PAH patients receiving Sitaxentan |
Primary outcome
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation
Time frame: Day 1 to Month 6
Participants still receiving Thelin with evidence of receipt of another PAH-related therapy (eg. bosentan, sildenafil) not previously received during the study period. Mean time in months to therapy augmentation.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching
Time frame: Day 1 to Month 6
Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation
Time frame: Day 1 to Month 6
Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration
Time frame: Day 1 to Month 6
Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed
Time frame: Day 1 to Month 6
Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage
Time frame: Day 1 to Month 6
Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.
19 secondary outcomes
Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications
Time frame: Day 1 to Month 6
Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension
Time frame: Baseline to Month 6
Change From Baseline in Mean Right Atrial Pressure
Time frame: Baseline to Month 6
Change From Baseline in Mean Pulmonary Artery Pressure
Time frame: Baseline to Month 6
Change From Baseline in Pulmonary Capillary Wedge Pressure
Time frame: Baseline to Month 6
Change From Baseline in Left Ventricular End Diastolic Pressure
Time frame: Baseline to Month 6
Change From Baseline in Pulmonary Vascular Resistance
Time frame: Baseline to Month 6
Change From Baseline in Cardiac Output
Time frame: Baseline to Month 6
Change From Baseline in Tei Index
Time frame: Baseline to Month 6
Change From Baseline in Tricuspid Regurgitant Velocity
Time frame: Baseline to Month 6
Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)
Time frame: Baseline to Month 6
Change From Baseline in Borg Dyspnoea Score
Time frame: Baseline to Month 6
Change From Baseline in Percent of Predicted Peak VO2
Time frame: Baseline to Month 6
Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening
Time frame: Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality
Time frame: Day 1 to Month 6
Number of Hospitalizations
Time frame: Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation
Time frame: Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation
Time frame: Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy
Time frame: Day 1 to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation (time frame: Day 1 to Month 6). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.