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
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, see Learn About Clinical Studies.

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 August 26, 2014