A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

This study has been terminated.

(Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.)

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01204853

First received: August 6, 2010

Last updated: October 26, 2011

Last verified: October 2011

History of Changes

Results First Received: October 26, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypertension, Pulmonary
Intervention:	Drug: Sitaxentan

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Sitaxentan Treatment	All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.

Participant Flow: Overall Study

	Sitaxentan Treatment
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Sitaxentan Treatment	All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.

Baseline Measures

	Sitaxentan Treatment
Number of Participants [units: participants]	2
Age, Customized [units: Participant]
<=18 years	0
19-64 years	1
>=65 years	1
Gender [units: Participants]
Female	2
Male	0

Outcome Measures

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1. Primary:

Number of Participants With Adverse Events [ Time Frame: 12 weeks ]

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Measure Type	Primary
Measure Title	Number of Participants With Adverse Events
Measure Description	Number of participants with any adverse events, severe adverse events, serious adverse events
Time Frame	12 weeks
Safety Issue	Yes

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.
Safety analysis set is defined as all participants who receive at least one dose of the study drug. Descriptive statistics for adverse events were not calculated due to a small number of subjects.

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.

Safety analysis set is defined as all participants who receive at least one dose of the study drug.

Descriptive statistics for adverse events were not calculated due to a small number of subjects.

Reporting Groups

	Description
Sitaxentan Treatment	All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.

Measured Values

	Sitaxentan Treatment
Number of Participants Analyzed [units: participants]	2
Number of Participants With Adverse Events [units: Participant]
All-causality adverse events	1
All-causality serious adverse events	0
All-causality severe adverse events	0

No statistical analysis provided for Number of Participants With Adverse Events

2. Primary:

Change From Baseline in 6-minute Walk Distance [ Time Frame: 12 weeks ]

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3. Secondary:

Change From Baseline in WHO Functional Class [ Time Frame: 12 weeks ]

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4. Secondary:

Number of Participants With Haemodynamics Parameters [ Time Frame: 12 weeks ]

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5. Secondary:

Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) [ Time Frame: 12 weeks ]

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6. Secondary:

Clinical Worsening [ Time Frame: 12 weeks ]

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7. Secondary:

Number of Participants With Pharmacokinetic (PK) Parameters at Steady State [ Time Frame: pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination ]

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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
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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:	NCT01204853 History of Changes
Other Study ID Numbers:	B1321052
Study First Received:	August 6, 2010
Results First Received:	October 26, 2011
Last Updated:	October 26, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

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