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

History of Changes

Results First Received: February 14, 2012

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Retrospective
Condition:	Pulmonary Arterial Hypertension
Intervention:	Drug: Sitaxentan sodium

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Data for this retrospective non-interventional study were abstracted from the medical records of subjects who met study entry criteria.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patterns of treatment with Thelin including duration and daily dosages reflect treatment participants received in clinical practice. Treatment was not specified by the protocol.

Reporting Groups

	Description
Sitaxentan (Thelin)	Duration and dose as prescribed in clinical practice.

Participant Flow: Overall Study

	Sitaxentan (Thelin)
STARTED	36
COMPLETED	36
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Sitaxentan (Thelin)	Duration and dose as prescribed in clinical practice.

Baseline Measures

	Sitaxentan (Thelin)
Number of Participants [units: participants]	36
Age, Customized [units: participants]
19 to 24 years	0
25 to 30 years	2
31 to 36 years	2
37 to 42 years	1
43 to 48 years	2
49 to 54 years	4
55 to 60 years	2
61 to 66 years	5
67 to 72 years	9
73 to 78 years	7
79 to 84 years	1
85 to 90 years	1
Gender [units: participants]
Female	29
Male	7

Outcome Measures

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1. Primary:

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation [ Time Frame: Day 1 to Month 6 ]

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2. Primary:

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching [ Time Frame: Day 1 to Month 6 ]

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3. Primary:

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation [ Time Frame: Day 1 to Month 6 ]

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4. Primary:

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration [ Time Frame: Day 1 to Month 6 ]

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Measure Type	Primary
Measure Title	Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration
Measure Description	Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.
Time Frame	Day 1 to Month 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS; participants without evidence of discontinuation of Thelin therapy were censored at the end of follow-up (at 6 months or death if prior to 6 months).

Reporting Groups

	Description
Sitaxentan (Thelin)	Duration and dose as prescribed in clinical practice.

Measured Values

	Sitaxentan (Thelin)
Number of Participants Analyzed [units: participants]	36
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration [units: months] Mean ± Standard Deviation	6 ± 0

No statistical analysis provided for Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration

5. Primary:

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed [ Time Frame: Day 1 to Month 6 ]

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6. Primary:

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage [ Time Frame: Day 1 to Month 6 ]

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7. Secondary:

Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications [ Time Frame: Day 1 to Month 6 ]

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8. Secondary:

Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension [ Time Frame: Baseline to Month 6 ]

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9. Secondary:

Change From Baseline in Mean Right Atrial Pressure [ Time Frame: Baseline to Month 6 ]

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10. Secondary:

Change From Baseline in Mean Pulmonary Artery Pressure [ Time Frame: Baseline to Month 6 ]

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11. Secondary:

Change From Baseline in Pulmonary Capillary Wedge Pressure [ Time Frame: Baseline to Month 6 ]

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12. Secondary:

Change From Baseline in Left Ventricular End Diastolic Pressure [ Time Frame: Baseline to Month 6 ]

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13. Secondary:

Change From Baseline in Pulmonary Vascular Resistance [ Time Frame: Baseline to Month 6 ]

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14. Secondary:

Change From Baseline in Cardiac Output [ Time Frame: Baseline to Month 6 ]

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15. Secondary:

Change From Baseline in Tei Index [ Time Frame: Baseline to Month 6 ]

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16. Secondary:

Change From Baseline in Tricuspid Regurgitant Velocity [ Time Frame: Baseline to Month 6 ]

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17. Secondary:

Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) [ Time Frame: Baseline to Month 6 ]

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18. Secondary:

Change From Baseline in Borg Dyspnoea Score [ Time Frame: Baseline to Month 6 ]

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19. Secondary:

Change From Baseline in Percent of Predicted Peak VO2 [ Time Frame: Baseline to Month 6 ]

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20. Secondary:

Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening [ Time Frame: Day 1 to Month 6 ]

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21. Secondary:

Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality [ Time Frame: Day 1 to Month 6 ]

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22. Secondary:

Number of Hospitalizations [ Time Frame: Day 1 to Month 6 ]

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23. Secondary:

Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation [ Time Frame: Day 1 to Month 6 ]

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24. Secondary:

Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation [ Time Frame: Day 1 to Month 6 ]

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25. Secondary:

Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy [ Time Frame: Day 1 to Month 6 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

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

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