Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01445873
First received: September 30, 2011
Last updated: May 9, 2012
Last verified: September 2011
  Purpose

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.


Condition Intervention
Pulmonary Arterial Hypertension
Drug: Sitaxentan sodium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation [ Time Frame: Day 1 to Month 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.


Secondary Outcome Measures:
  • Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications [ Time Frame: Day 1 to Month 6 ] [ Designated as safety issue: No ]
    Use of PAH-related medications other than Thelin described by class of agent received.

  • Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Mean Right Atrial Pressure [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Difference between pre-index and follow-up value.

  • Change From Baseline in Mean Pulmonary Artery Pressure [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Difference between pre-index and follow-up value.

  • Change From Baseline in Pulmonary Capillary Wedge Pressure [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Difference between pre-index and follow-up value.

  • Change From Baseline in Left Ventricular End Diastolic Pressure [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Difference between pre-index and follow-up value.

  • Change From Baseline in Pulmonary Vascular Resistance [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Difference between pre-index and follow-up value.

  • Change From Baseline in Cardiac Output [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Difference between pre-index and follow-up value.

  • Change From Baseline in Tei Index [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Tricuspid Regurgitant Velocity [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Difference between pre-index and follow-up value.

  • Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Borg Dyspnoea Score [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Percent of Predicted Peak VO2 [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Difference between pre-index and follow-up value.

  • Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening [ Time Frame: Day 1 to Month 6 ] [ Designated as safety issue: No ]
    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.

  • Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality [ Time Frame: Day 1 to Month 6 ] [ Designated as safety issue: No ]
    Number of participants who died during the follow-up period.

  • Number of Hospitalizations [ Time Frame: Day 1 to Month 6 ] [ Designated as safety issue: No ]
    All hospitalizations during the follow-up period recorded in medical records.

  • Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation [ Time Frame: Day 1 to Month 6 ] [ Designated as safety issue: No ]
    Number of participants who received an lung transplant during hospitalization.

  • Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation [ Time Frame: Day 1 to Month 6 ] [ Designated as safety issue: No ]
    Number of participants who received an heart/lung transplant during hospitalization.

  • Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy [ Time Frame: Day 1 to Month 6 ] [ Designated as safety issue: No ]
    Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.


Enrollment: 36
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PAH patients receiving Sitaxentan Drug: Sitaxentan sodium
Sitaxentan sodium 100 mg / day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445873

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01445873     History of Changes
Other Study ID Numbers: B1321051
Study First Received: September 30, 2011
Results First Received: February 14, 2012
Last Updated: May 9, 2012
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
Pulmonary arterial hypertension
sitaxentan sodium
Thelin

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 20, 2014