Not provided
Not provided
Not provided
Not provided
Not provided
Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitaxentan treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitaxentan | Drug | sitaxentan sodium 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of participants with any adverse events, severe adverse events, serious adverse events | 12 weeks |
| Change From Baseline in 6-minute Walk Distance | Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WHO Functional Class | 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. | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Nagoya | Aichi-ken | Japan | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Number of participants with any adverse events, severe adverse events, serious adverse events | 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. | Posted | Number | Participant | 12 weeks |
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C106276 | sitaxsentan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Number of Participants With Haemodynamics Parameters | 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. | 12 weeks |
| Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) | Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline. | 12 weeks |
| Clinical Worsening | 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. | 12 weeks |
| Number of Participants With Pharmacokinetic (PK) Parameters at Steady State | 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. | 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 |
| Shinjyuku-ku |
| Tokyo |
| Japan |
| Participant |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Change From Baseline in 6-minute Walk Distance | Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline. | 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. | Posted | Mean | Standard Deviation | Meters | 12 weeks |
|
|
| Secondary | Change From Baseline in WHO Functional Class | 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. | 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. | Posted | Number | Percentage of participants | 12 weeks |
|
|
| Secondary | Number of Participants With Haemodynamics Parameters | 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. | 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. | Posted | Number | Participants | 12 weeks |
|
|
| Secondary | Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) | Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline. | 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. | Posted | Mean | Standard Deviation | pg/mL | 12 weeks |
|
|
| Secondary | Clinical Worsening | 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. | 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. | Posted | Number | Participants | 12 weeks |
|
|
| Secondary | Number of Participants With Pharmacokinetic (PK) Parameters at Steady State | 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. | 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. | Posted | Number | Participants | 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 |
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
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.
| D002318 |
| Cardiovascular Diseases |