Trial Outcomes & Findings for A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients (NCT NCT01204853)

Results Overview

Number of participants with any adverse events, severe adverse events, serious adverse events

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2 participants

Primary outcome timeframe

12 weeks

Results posted on

2011-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitaxentan Treatment n=2 Participants 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.
Age, Customized <=18 years	0 Participant n=5 Participants
Age, Customized 19-64 years	1 Participant n=5 Participants
Age, Customized >=65 years	1 Participant n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 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.

Number of participants with any adverse events, severe adverse events, serious adverse events

Outcome measures

Outcome measures
Measure	Sitaxentan Treatment n=2 Participants 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.
Number of Participants With Adverse Events All-causality adverse events	1 Participant
Number of Participants With Adverse Events All-causality serious adverse events	0 Participant
Number of Participants With Adverse Events All-causality severe adverse events	0 Participant

PRIMARY outcome

Timeframe: 12 weeks

Population: Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments. Descriptive statistics for change from baseline in 6-minute walk distance were not calculated due to a small number of participants.

Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments. Descriptive statistics for change from baseline in WHO functional class 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 at Week 12 was to be summarized with frequency count and percentage in each category based on imputed data for missing values at Week 12.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments. Descriptive statistics for change from baseline in haemodynamics parameters were not calculated due to a small number of participants.

The following haemodynamic measurements were assessed: right arterial pressure, pulmonary arterial systolic pressure, pulmonary arterial diastolic pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, left ventricular-end diastolic pressure, cardiac output, systemic arterial blood pressure (systolic, diastolic and mean), and heart rate. Change from baseline in haemodynamics parameters is calculated as the value at Week 12 minus value at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments. Descriptive statistics for change from baseline in NT-pro BNP were not calculated due to a small number of participants.

Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments. Descriptive statistics for clinical worsening 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: 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

Population: The PK concentration set was defined as all participants who have at least 1 concentration. The PK parameter analysis set was defined as all participants who have at least 1 of PK parameters of interest. Descriptive statistics for PK parameters were not calculated due to a small number of participants.

The following PK parameters at the steady state were evaluated: maximum observed concentration during the dosing interval (Cmax), time for maximum observed concentration during the dosing interval (Tmax), area under the plasma concentration-time curve over dosing interval tau for multiple dose (AUCtau), terminal elimination half-life (t1/2), apparent clearance (CL/F) and apparent volume of distribution during the terminal elimination phase (Vz/F) at Week 12/Termination (as data permit), and concentration predose during multiple dosing (Ctrough) at Week 2, 4, 8 and 12/Termination.

Outcome measures

Outcome data not reported

Adverse Events

Sitaxentan Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sitaxentan Treatment n=2 participants at risk 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.
Gastrointestinal disorders Abdominal pain	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.
General disorders Chest pain	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.
General disorders Oedema	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.
Musculoskeletal and connective tissue disorders Myalgia	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 Dizziness	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.
Psychiatric disorders Panic attack	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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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.
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Restriction type: OTHER