Trial Outcomes & Findings for Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients (NCT NCT01210443)
NCT ID: NCT01210443
Last Updated: 2011-12-14
Results Overview
Number of participants with any adverse events, severe adverse events, serious adverse events
TERMINATED
PHASE3
2 participants
Up to 22 days (last participant discontinuation)
2011-12-14
Participant Flow
Participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks in preceding B1321052 study.
Participant milestones
| Measure |
Sitaxentan Treatment
All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
|
|---|---|
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Overall Study
STARTED
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2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Sitaxentan Treatment
All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
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|---|---|
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Overall Study
Study terminated by sponsor
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2
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Baseline Characteristics
Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
Baseline characteristics by cohort
| Measure |
Sitaxentan Treatment
n=2 Participants
All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
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|---|---|
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Age, Customized
<=18 years
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0 Participants
n=5 Participants
|
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Age, Customized
19-64 years
|
1 Participants
n=5 Participants
|
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Age, Customized
>=65 years
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1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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2 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 22 days (last participant discontinuation)Population: The safety analysis set is defined as all subjects who receive at least one dose of study drug during this extension study.
Number of participants with any adverse events, severe adverse events, serious adverse events
Outcome measures
| Measure |
Sitaxentan Treatment
n=2 Participants
All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
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|---|---|
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Number of Participants With Adverse Events
Treatment emergent all-causality adverse events
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1 Participants
|
|
Number of Participants With Adverse Events
Treatment emergen-causality serious adverse events
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0 Participants
|
|
Number of Participants With Adverse Events
Treatment emergent all-causality severe adverse ev
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 22 days (last participant discontinuation)Population: The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments. Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants.
Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 days (last participant discontinuation)Population: The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments. Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants.
Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 days (last participant discontinuation)Population: The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments. Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants.
The change from baseline in WHO functional class was classified into "Improved", "No change" and "Worsened". The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 days (last participant discontinuation)Population: The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments. Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants.
Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.
Outcome measures
Outcome data not reported
Adverse Events
Sitaxentan Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sitaxentan Treatment
n=2 participants at risk
All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
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|---|---|
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Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
50.0%
1/2
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER