Pulmonary Arterial Hypertension
Conditions
Keywords
Open-label study
Brief summary
This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.
Detailed description
Open-label extension
Interventions
DRUGSitaxsentan
Sitaxsentan 100 mg tablets once daily
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization. * Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.
Exclusion criteria
* Has portal hypertension or chronic liver disease. * Has history of left sided heart disease or significant cardiac disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to 82 months | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported. |
| The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN) | Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months | ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. |
| The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months | ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. |
| Percentage of Participants With Total Bilirubin > 1.5 x ULN | Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months | Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. |
| Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months | Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. |
| Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months | Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. |
| Percentage of Participants With Laboratory Test Abnormalities (Urinalysis) | Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months | Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. |
| Percentage of Participants With Anticoagulant Use | Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months | Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan. |
| Percentage of Participants With Elevated International Normalize Ratio (INR) | Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months | Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as \> 3.5. Percentage calculated using number of participants with INR data as the denominator. |
| Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance | Weeks 28,60,72,84,96,104, Transition Visit up to 82 months | Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement. |
| Percentage of Participants With Vital Sign Results of Potential Clinical Importance | Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months | Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement. |
| Percentage of Participants With Abnormal Prothrombin Time (PT) | Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months | PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. |
| Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT) | Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months | PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled from studies FPH02/FPH02-X (STRIDE 2/STRIDE 2 Extension \[NCT00080457, NCT00593905\]), FPH04 (STRIDE 4), FPH06 (STRIDE 6) or were naive to sitaxsentan sodium.
Participants by arm
| Arm | Count |
|---|---|
| Sitaxsentan All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study. | 1,192 |
| Total | 1,192 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Additional Chronic Treatment | 31 |
| Overall Study | Adverse Event | 79 |
| Overall Study | ALT/AST >3x UNL, Bilirubin >2xUNL | 4 |
| Overall Study | ALT/AST >5x Upper Limit of Normal (ULN) | 70 |
| Overall Study | Death | 147 |
| Overall Study | Investigator Decision | 57 |
| Overall Study | Lost to Follow-up | 19 |
| Overall Study | Other | 26 |
| Overall Study | Pregnancy | 6 |
| Overall Study | Sponsor Decision | 450 |
| Overall Study | WHO FC deterioration and 6MWD decrease | 9 |
| Overall Study | Withdrawal by Subject | 70 |
Baseline characteristics
| Characteristic | Sitaxsentan |
|---|---|
| Age, Customized 18-44 years | 433 participants |
| Age, Customized 45-64 years | 468 participants |
| Age, Customized greater than or equal to 65 years | 256 participants |
| Age, Customized less than (<) 18 years | 35 participants |
| Sex: Female, Male Female | 914 Participants |
| Sex: Female, Male Male | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,069 / 1,192 |
| serious Total, serious adverse events | 586 / 1,192 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
Time frame: Day 1 up to 82 months
Population: Safety Population: all enrolled participants who took at least one dose of sitaxsentan 100 mg during the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 1150 participants |
| Sitaxsentan | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 586 participants |
Primary
Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)
PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Time frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Population: Data not summarized, study terminated early
Primary
Percentage of Participants With Abnormal Prothrombin Time (PT)
PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Time frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Population: Data not summarized, study terminated early
Primary
Percentage of Participants With Anticoagulant Use
Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.
Time frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan | Percentage of Participants With Anticoagulant Use | Warfarin before first dose | 39.77 percentage of participants |
| Sitaxsentan | Percentage of Participants With Anticoagulant Use | Warfarin Derivatives before first dose | 19.13 percentage of participants |
| Sitaxsentan | Percentage of Participants With Anticoagulant Use | Other Anticoagulants before first dose | 2.01 percentage of participants |
| Sitaxsentan | Percentage of Participants With Anticoagulant Use | Warfarin from first dose/data cut off | 58.22 percentage of participants |
| Sitaxsentan | Percentage of Participants With Anticoagulant Use | Warfarin Derivatives from first dose/data cut off | 20.55 percentage of participants |
| Sitaxsentan | Percentage of Participants With Anticoagulant Use | Other Anticoagulants from first dose/data cut off | 2.52 percentage of participants |
Primary
Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance
Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.
Time frame: Weeks 28,60,72,84,96,104, Transition Visit up to 82 months
Population: Data not summarized, study terminated early
Primary
Percentage of Participants With Elevated International Normalize Ratio (INR)
Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as \> 3.5. Percentage calculated using number of participants with INR data as the denominator.
Time frame: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR >9; no anticoagulant | 0.25 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR <= 3.5; warfarin | 20.97 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR >3.5 and <=5; warfarin | 17.70 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR >5 and <=9; warfarin | 12.75 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR > 9; warfarin | 3.44 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR <=3.5; warfarin derivatives | 4.95 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR >3.5 and <=5; warfarin derivatives | 6.96 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR >5 and <=9; warfarin derivatives | 5.96 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR >9; warfarin derivatives | 1.85 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR <=3.5; other anticoagulant | 1.34 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR >3.5 and <=5; other anticoagulant | 0.59 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR >5 and <= 9; other anticoagulant | 0.50 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR <=3.5; no anticoagulant | 19.55 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR >3.5 and <= 5; no anticoagulant | 0.17 percentage of participants |
| Sitaxsentan | Percentage of Participants With Elevated International Normalize Ratio (INR) | INR >5 and <=9; no anticoagulant | 0.42 percentage of participants |
Primary
Percentage of Participants With Laboratory Test Abnormalities (Chemistry)
Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Population: Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Albumin (n=33) | 45.5 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline Phosphatase (n=593) | 45.5 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | ALT (n=839) | 36.1 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Amylase (n=9) | 0 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | AST (n=814) | 49.4 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Bicarbonate (n=540) | 56.7 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Blood urea nitrogen (BUN) (n=615) | 42.4 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Calcium (n=819) | 21.4 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Chloride (n=804) | 31 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Creatinine (n=808) | 25 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Direct Bilirubin (n=11) | 54.5 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Gamma glutamyltransferase (GGT) (n=22) | 45.5 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Glucose (n=674) | 61.6 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Glucose-fasting (n=2) | 50 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Indirect Bilirubin (n=11) | 45.5 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Phosphorus (n=740) | 50.8 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Potassium (n=749) | 51.8 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Sodium (n=811) | 29.1 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Total Bilirubin (n=726) | 27.7 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Total Protein (n=738) | 38.1 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Urea (n=35) | 48.6 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Chemistry) | Uric Acid (n=415) | 46.5 percentage of participants |
Primary
Percentage of Participants With Laboratory Test Abnormalities (Hematology)
Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Population: Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Basophiles (n=814) | 4.1 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Eosinophiles % (n=3) | 100 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Eosinophils (n=785) | 20.6 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Hematocrit (n=537) | 46.2 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin (n=573) | 48.7 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocytes (n=737) | 35.5 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Mean Corpuscular Hemoglobin (n=56) | 21.4 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Mean Corpuscular Hemoglobin Concentration (n=59) | 33.9 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Mean Corpuscular Volume (n=65) | 27.7 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Monocytes (n=766) | 28.3 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Neutrophiles (n=728) | 38 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Platelets Count (n=719) | 26.3 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | Red Blood Cells (n=542) | 39.1 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells (n=730) | 35.3 percentage of participants |
Primary
Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)
Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Population: Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Urinalysis) | PH (n=789) | 0 percentage of participants |
| Sitaxsentan | Percentage of Participants With Laboratory Test Abnormalities (Urinalysis) | Specific Gravity (n=787) | 1.8 percentage of participants |
Primary
Percentage of Participants With Total Bilirubin > 1.5 x ULN
Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan | Percentage of Participants With Total Bilirubin > 1.5 x ULN | >= 1.5 x ULN and <2 x ULN | 10.23 percentage of participants |
| Sitaxsentan | Percentage of Participants With Total Bilirubin > 1.5 x ULN | >= 2 x ULN and < 3x ULN | 6.80 percentage of participants |
| Sitaxsentan | Percentage of Participants With Total Bilirubin > 1.5 x ULN | >= 3x ULN | 5.03 percentage of participants |
Primary
Percentage of Participants With Vital Sign Results of Potential Clinical Importance
Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.
Time frame: Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months
Population: Data not summarized, study terminated early
Primary
The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN)
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan | The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN) | > 3 x ULN and less than or equal to (<=) 5x ULN | 5.12 percentage of participants |
| Sitaxsentan | The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN) | > 5 x ULN and <= 8 x ULN | 4.45 percentage of participants |
| Sitaxsentan | The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN) | > 8 x ULN and <= 10 x ULN | 0.76 percentage of participants |
| Sitaxsentan | The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN) | > 10 x ULN | 2.60 percentage of participants |
Primary
The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitaxsentan | The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | > 3 x ULN and <= 5 x ULN | 3.94 percentage of participants |
| Sitaxsentan | The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | > 5 x ULN and <= 8 x ULN | 2.60 percentage of participants |
| Sitaxsentan | The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | > 8 x ULN and <= 10 x ULN | 0.67 percentage of participants |
| Sitaxsentan | The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN | > 10 x ULN | 1.26 percentage of participants |