Pulmonary Arterial Hypertension
Conditions
Keywords
Pulmonary Arterial Hypertension, tyrosine kinase inhibitor, STI571
Brief summary
This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension
Interventions
DRUGImatinib mesylate
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of PAH of either primary (idiopathic), familial or secondary to systemic sclerosis (excluding those with marked pulmonary fibrosis) according to World Conference on Pulmonary Hypertension classification (Venice, 2003). * Symptoms with a WHO class of II-IV
Exclusion criteria
* Use of unspecific phosphodiesterase inhibitors (for example, pentoxyfillin, enoximon, milrinone or pimobendan) during the study * Chronic inhaled nitric oxide therapy from start to study completion * Treatment with catecholamines (for example, adrenalin, noradrenalin, dopamine), * Pre-existing lung diseases, including parasitic diseases affecting lungs, asthma, congenital abnormalities of the lungs, chest, and diaphragm. * Pulmonary artery or valve stenosis; pulmonary venous hypertension; chronic thromboembolic pulmonary hypertension * Acute heart failure or chronic left sided heart failure; congenital or acquired valvular or myocardial disease * Severe (systemic) arterial hypertension (\> 200 mmHg (systolic) or \> 120 mmHg (diastolic)) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core | 6 months | In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section. |
| Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension | 72 months | In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section. |
| Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) | The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Distance \<500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance \>800 meters (with no rests) suggests mild or no limitation. |
| Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) | The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Number of stops were recorded for each patient. |
| Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) | The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. If the patient stopped the duration of each stop was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Borg Score During the Six Minutes Walk Test at Different Time Periods | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) | Borg Score during Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Borg Score of Breathlessness was recorded using the following score of 0 to 10, how breathless do you feel? 0 is nothing at all and 10 is maximal breathlessness |
| Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including right Pulmonary Arterial Pressure (PAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. |
| Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Arterial Wedge Pressure (PAWP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. |
| Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systolic Arterial Pressure (SAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. |
| Mean Heart Rate (HR) at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Heart Rate (HR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. |
| Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Cardiac Output (CO). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. |
| Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. PVR calculated according to the equation:PVR = (PAP - PCWP)/CO |
| Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion | PAH assessed according to the WHO classification: Class I Patients with PAH but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PAH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PAH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PAH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity. |
| Blood Gas Measurement - PvO2 at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PvO2 levels at baseline and Study completion Week 24. |
| Blood Gas Measurement - PaO2 at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaO2 levels at baseline and Study completion Week 24. |
| Blood Gas Measurement - PaCO2 at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaCO2 levels at baseline and Study completion Week 24. |
| Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Arterial Saturation levels at baseline and Study completion Week 24. |
| Blood Gas Measurement - Venous Saturation at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Venous Saturation levels at baseline and Study completion Week 24. |
| Blood Gas Measurement - pH at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including pH levels at baseline and Study completion Week 24. The pH scale measures how acidic or basic a substance is. It ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. |
| Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline, and Study completion (Week 24) | The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systemic Vascular Resistance (SVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. SVR was calculated according to the equation: SVR = (Paorta - Pright atrium)/CO |
| Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) | Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. The test was terminated if the patient became too distressed or if their SaO2% fell below 60%. |
| Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) | Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Systolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test |
| Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) | Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Diastolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test |
| Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) | Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Heart Rate (bpm) were recorded before the test at resting, at the end of the test and two minutes after the end of the test |
Countries
Austria, Germany, United Kingdom, United States
Participant flow
Recruitment details
Of the 42 participants that completed the Core Study only 22 Participants continued into the Open Label Extension. Not all participants were required to continue into the extension from the core.
Participants by arm
| Arm | Count |
|---|---|
| STI571 STI571 | 28 |
| Placebo Placebo | 31 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Core Study | Adverse Event | 6 | 4 | 0 |
| Core Study | Death | 3 | 3 | 0 |
| Core Study | Withdrawn Consent | 0 | 1 | 0 |
| Open Label Extension | Abnormal laboratory values | 0 | 0 | 1 |
| Open Label Extension | Adminiatrative problems | 0 | 0 | 2 |
| Open Label Extension | Adverse Event | 0 | 0 | 4 |
| Open Label Extension | Death | 0 | 0 | 4 |
| Open Label Extension | unsatisfactory therapeutic effects | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | STI571 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 15.3 | 44.2 years STANDARD_DEVIATION 15.7 | 44.3 years STANDARD_DEVIATION 15.4 |
| Sex: Female, Male Female | 18 Participants | 22 Participants | 40 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 26 / 28 | 25 / 31 | 21 / 22 |
| serious Total, serious adverse events | 12 / 28 | 11 / 31 | 16 / 22 |
Outcome results
Primary
Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods
The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Number of stops were recorded for each patient.
Time frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | Day 32 (n=25,27) | -0.2 number of stops | Standard Deviation 0.7 |
| STI571 | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | week 8 (n=23,24) | -0.2 number of stops | Standard Deviation 0.7 |
| STI571 | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | week 12 (n=22,24) | -0.3 number of stops | Standard Deviation 0.9 |
| STI571 | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | week 16 (n=19, 23) | -0.3 number of stops | Standard Deviation 0.8 |
| STI571 | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | week 20 (n=19, 21) | -0.4 number of stops | Standard Deviation 1 |
| STI571 | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | study completion Week 24 (n=21, 12) | -0.3 number of stops | Standard Deviation 0.8 |
| Placebo | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | week 20 (n=19, 21) | 0.3 number of stops | Standard Deviation 1 |
| Placebo | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | Day 32 (n=25,27) | 0.1 number of stops | Standard Deviation 0.4 |
| Placebo | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | week 16 (n=19, 23) | 0.0 number of stops | Standard Deviation 0.2 |
| Placebo | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | week 8 (n=23,24) | 0.0 number of stops | Standard Deviation 1.1 |
| Placebo | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | study completion Week 24 (n=21, 12) | -0.1 number of stops | Standard Deviation 0.5 |
| Placebo | Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods | week 12 (n=22,24) | 0.3 number of stops | Standard Deviation 0.9 |
Primary
Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods
The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Distance \<500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance \>800 meters (with no rests) suggests mild or no limitation.
Time frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | Day 32 (n=25,27) | 10.2 meters | Standard Deviation 53.7 |
| STI571 | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | week 8 (n=23,24) | 17.0 meters | Standard Deviation 55.6 |
| STI571 | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | week 12 (n=22,24) | 21 meters | Standard Deviation 36.2 |
| STI571 | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | week 16 (n=19, 23) | 25.5 meters | Standard Deviation 43.1 |
| STI571 | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | week 20 (n=19, 21) | 38.3 meters | Standard Deviation 42.5 |
| STI571 | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | study completion Week 24 (n=21, 12) | 22.0 meters | Standard Deviation 63.1 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | week 20 (n=19, 21) | 12.8 meters | Standard Deviation 60.4 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | Day 32 (n=25,27) | 8.2 meters | Standard Deviation 27.5 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | week 16 (n=19, 23) | 12.1 meters | Standard Deviation 47.9 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | week 8 (n=23,24) | 15.5 meters | Standard Deviation 40.8 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | study completion Week 24 (n=21, 12) | -1.0 meters | Standard Deviation 53.3 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods | week 12 (n=22,24) | 7.8 meters | Standard Deviation 50 |
Primary
Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods
The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. If the patient stopped the duration of each stop was recorded.
Time frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | Day 32 (n=25,27) | -0.06 minutes | Standard Deviation 0.19 |
| STI571 | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | week 8 (n=23,24) | -0.03 minutes | Standard Deviation 0.1 |
| STI571 | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | week 12 (n=22,24) | -0.03 minutes | Standard Deviation 0.1 |
| STI571 | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | week 16 (n=19, 23) | -0.03 minutes | Standard Deviation 0.1 |
| STI571 | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | week 20 (n=19, 21) | -0.05 minutes | Standard Deviation 0.15 |
| STI571 | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | study completion Week 24 (n=21, 12) | -0.02 minutes | Standard Deviation 0.1 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | week 20 (n=19, 21) | 0.12 minutes | Standard Deviation 0.42 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | Day 32 (n=25,27) | 0.12 minutes | Standard Deviation 0.36 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | week 16 (n=19, 23) | 0.06 minutes | Standard Deviation 0.26 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | week 8 (n=23,24) | 0.07 minutes | Standard Deviation 0.27 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | study completion Week 24 (n=21, 12) | 0.03 minutes | Standard Deviation 0.18 |
| Placebo | Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods | week 12 (n=22,24) | 0.19 minutes | Standard Deviation 0.55 |
Primary
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core
In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.
Time frame: 6 months
Population: Safety Population all participants enrolled was included in this population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| STI571 | Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core | Paients with AE(s) | 27 participants |
| STI571 | Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core | Death | 3 participants |
| STI571 | Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core | SAE(s) | 12 participants |
| Placebo | Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core | Paients with AE(s) | 29 participants |
| Placebo | Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core | Death | 3 participants |
| Placebo | Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core | SAE(s) | 11 participants |
Primary
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension
In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.
Time frame: 72 months
Population: No formal statistical analysis was performed in the extension phase of this study so no analysis data sets were defined. All summaries are based on all patients enrolled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| STI571 | Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension | Any AE(s) | 22 participants |
| STI571 | Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension | Death | 4 participants |
| STI571 | Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension | SAE(s) | 16 participants |
Secondary
Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion
The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Arterial Saturation levels at baseline and Study completion Week 24.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion | Baseline n=19,16 | 87.99 percentage of saturation | Standard Deviation 9.19 |
| STI571 | Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion | Week 24 n=14,15 | 92.89 percentage of saturation | Standard Deviation 4.5 |
| Placebo | Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion | Baseline n=19,16 | 91.81 percentage of saturation | Standard Deviation 4.05 |
| Placebo | Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion | Week 24 n=14,15 | 91.78 percentage of saturation | Standard Deviation 3.36 |
Secondary
Blood Gas Measurement - PaCO2 at Baseline and Study Completion
The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaCO2 levels at baseline and Study completion Week 24.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Blood Gas Measurement - PaCO2 at Baseline and Study Completion | Baseline n=23,21 | 32.70 mmHg | Standard Deviation 4.4 |
| STI571 | Blood Gas Measurement - PaCO2 at Baseline and Study Completion | Week 24 n=16,17 | 33.36 mmHg | Standard Deviation 5.11 |
| Placebo | Blood Gas Measurement - PaCO2 at Baseline and Study Completion | Baseline n=23,21 | 30.02 mmHg | Standard Deviation 4.76 |
| Placebo | Blood Gas Measurement - PaCO2 at Baseline and Study Completion | Week 24 n=16,17 | 30.23 mmHg | Standard Deviation 3.55 |
Secondary
Blood Gas Measurement - PaO2 at Baseline and Study Completion
The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaO2 levels at baseline and Study completion Week 24.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Blood Gas Measurement - PaO2 at Baseline and Study Completion | Baseline n=22,21 | 63.36 mmHg | Standard Deviation 14.33 |
| STI571 | Blood Gas Measurement - PaO2 at Baseline and Study Completion | Week 24 n=16,17 | 72.49 mmHg | Standard Deviation 14.09 |
| Placebo | Blood Gas Measurement - PaO2 at Baseline and Study Completion | Baseline n=22,21 | 63.75 mmHg | Standard Deviation 12.02 |
| Placebo | Blood Gas Measurement - PaO2 at Baseline and Study Completion | Week 24 n=16,17 | 70.13 mmHg | Standard Deviation 16.72 |
Secondary
Blood Gas Measurement - pH at Baseline and Study Completion
The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including pH levels at baseline and Study completion Week 24. The pH scale measures how acidic or basic a substance is. It ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Blood Gas Measurement - pH at Baseline and Study Completion | Baseline n=24,23 | 7.43 pH scale | Standard Deviation 0.04 |
| STI571 | Blood Gas Measurement - pH at Baseline and Study Completion | Week 24 n=17,17 | 7.44 pH scale | Standard Deviation 0.05 |
| Placebo | Blood Gas Measurement - pH at Baseline and Study Completion | Baseline n=24,23 | 7.44 pH scale | Standard Deviation 0.05 |
| Placebo | Blood Gas Measurement - pH at Baseline and Study Completion | Week 24 n=17,17 | 7.46 pH scale | Standard Deviation 0.05 |
Secondary
Blood Gas Measurement - PvO2 at Baseline and Study Completion
The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PvO2 levels at baseline and Study completion Week 24.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Blood Gas Measurement - PvO2 at Baseline and Study Completion | Baseline n=14,14 | 33.16 mmHg | Standard Deviation 4.62 |
| STI571 | Blood Gas Measurement - PvO2 at Baseline and Study Completion | Week 24 n=11,11 | 35.56 mmHg | Standard Deviation 3.8 |
| Placebo | Blood Gas Measurement - PvO2 at Baseline and Study Completion | Baseline n=14,14 | 34.70 mmHg | Standard Deviation 4.75 |
| Placebo | Blood Gas Measurement - PvO2 at Baseline and Study Completion | Week 24 n=11,11 | 32.65 mmHg | Standard Deviation 4.18 |
Secondary
Blood Gas Measurement - Venous Saturation at Baseline and Study Completion
The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Venous Saturation levels at baseline and Study completion Week 24.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Blood Gas Measurement - Venous Saturation at Baseline and Study Completion | Baseline n=17,14 | 57.96 percentage of saturation | Standard Deviation 10.48 |
| STI571 | Blood Gas Measurement - Venous Saturation at Baseline and Study Completion | Week 24 n=13,13 | 65.11 percentage of saturation | Standard Deviation 6.91 |
| Placebo | Blood Gas Measurement - Venous Saturation at Baseline and Study Completion | Baseline n=17,14 | 60.84 percentage of saturation | Standard Deviation 6.61 |
| Placebo | Blood Gas Measurement - Venous Saturation at Baseline and Study Completion | Week 24 n=13,13 | 57.00 percentage of saturation | Standard Deviation 9.18 |
Secondary
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Diastolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test
Time frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: Resting (n= 26, 28) | 68.2 mmHg | Standard Deviation 10.2 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: End of Test (n= 21, 26) | 75.1 mmHg | Standard Deviation 10.8 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: 2 minutes after end of test (n=25, 27) | 71.6 mmHg | Standard Deviation 9.8 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: Resting (n= 25, 27) | 69.6 mmHg | Standard Deviation 10.4 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: End of Test (n= 22, 22) | 78.2 mmHg | Standard Deviation 12.3 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: 2 minutes after end of test (n= 25, 26) | 72.5 mmHg | Standard Deviation 9.1 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: Resting (n= 22, 24) | 67.7 mmHg | Standard Deviation 11.8 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: End of Test (n= 19, 20) | 74.8 mmHg | Standard Deviation 10.8 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: 2 minutes after end of test (n= 23, 24) | 71.2 mmHg | Standard Deviation 10.3 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: Resting (n= 22, 23) | 65.5 mmHg | Standard Deviation 8.3 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: End of Test (n= 17, 19) | 75.6 mmHg | Standard Deviation 11.5 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: 2 minutes after end of test (n= 20, 22) | 73.1 mmHg | Standard Deviation 8.9 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: Resting (n= 19, 22) | 67.7 mmHg | Standard Deviation 9.9 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: End of Test (n= 15,18) | 72.7 mmHg | Standard Deviation 9.2 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: 2 minutes after end of test (n= 19, 22) | 71.4 mmHg | Standard Deviation 11 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: Resting (n= 19, 20) | 67.2 mmHg | Standard Deviation 8 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: End of Test (n= 16,17) | 72.9 mmHg | Standard Deviation 8.7 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: 2 minutes after end of test (n= 19, 20) | 71.9 mmHg | Standard Deviation 9.2 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: Resting (n= 20, 21) | 69.7 mmHg | Standard Deviation 10.3 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: End of Test (n= 16, 17) | 74.1 mmHg | Standard Deviation 10.7 |
| STI571 | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: 2 minutes after end of test (n= 20, 19) | 71.3 mmHg | Standard Deviation 10.1 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: End of Test (n= 17, 19) | 72.4 mmHg | Standard Deviation 14.3 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: Resting (n= 26, 28) | 67.9 mmHg | Standard Deviation 8.9 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: Resting (n= 20, 21) | 70.7 mmHg | Standard Deviation 10.9 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: End of Test (n= 21, 26) | 69.5 mmHg | Standard Deviation 11.9 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: 2 minutes after end of test (n= 20, 22) | 72.0 mmHg | Standard Deviation 13.7 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: 2 minutes after end of test (n=25, 27) | 67.9 mmHg | Standard Deviation 9.6 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: End of Test (n= 16,17) | 72.9 mmHg | Standard Deviation 8.1 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: Resting (n= 25, 27) | 68.4 mmHg | Standard Deviation 8.8 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: Resting (n= 19, 22) | 66.7 mmHg | Standard Deviation 7.7 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: End of Test (n= 22, 22) | 75.2 mmHg | Standard Deviation 11.2 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: 2 minutes after end of test (n= 20, 19) | 72.9 mmHg | Standard Deviation 9.5 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: 2 minutes after end of test (n= 25, 26) | 70.7 mmHg | Standard Deviation 9.4 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: End of Test (n= 15,18) | 76.7 mmHg | Standard Deviation 8.6 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: Resting (n= 22, 24) | 68.8 mmHg | Standard Deviation 9 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: 2 minutes after end of test (n= 19, 20) | 72.7 mmHg | Standard Deviation 9.8 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: End of Test (n= 19, 20) | 74.0 mmHg | Standard Deviation 10.9 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: 2 minutes after end of test (n= 19, 22) | 70.5 mmHg | Standard Deviation 8 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: 2 minutes after end of test (n= 23, 24) | 72.2 mmHg | Standard Deviation 11.7 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: End of Test (n= 16, 17) | 72.3 mmHg | Standard Deviation 10.9 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: Resting (n= 22, 23) | 70.6 mmHg | Standard Deviation 11.6 |
| Placebo | Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: Resting (n= 19, 20) | 69.8 mmHg | Standard Deviation 8.8 |
Secondary
Borg Score During the Six Minutes Walk Test at Different Time Periods
Borg Score during Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Borg Score of Breathlessness was recorded using the following score of 0 to 10, how breathless do you feel? 0 is nothing at all and 10 is maximal breathlessness
Time frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Baseline: Resting (n= 26, 27) | 0.27 score on a scale | Standard Deviation 0.83 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Baseline: End of Test (n= 27, 29) | 3.34 score on a scale | Standard Deviation 2.3 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Baseline: 2 minutes after end of test (n=24, 26) | 0.88 score on a scale | Standard Deviation 1.67 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Day 32: Resting (n= 25, 27) | 0.24 score on a scale | Standard Deviation 0.83 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Day 32: End of Test (n= 25, 28) | 2.53 score on a scale | Standard Deviation 2.02 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Day 32: 2 minutes after end of test (n= 25, 26) | 0.65 score on a scale | Standard Deviation 2.06 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 8: Resting (n= 23, 24) | 0.32 score on a scale | Standard Deviation 1.02 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 8: End of Test (n= 23, 25) | 2.46 score on a scale | Standard Deviation 2.02 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 8: 2 minutes after end of test (n= 23, 24) | 0.32 score on a scale | Standard Deviation 0.92 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 12: Resting (n= 22, 24) | 0.05 score on a scale | Standard Deviation 0.21 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 12: End of Test (n= 22, 25) | 2.27 score on a scale | Standard Deviation 1.59 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 12: 2 minutes after end of test (n= 22, 23) | 0.35 score on a scale | Standard Deviation 0.68 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 16: Resting (n= 19, 23) | 0.13 score on a scale | Standard Deviation 0.33 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 16: End of Test (n= 18, 23) | 2.50 score on a scale | Standard Deviation 1.91 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 16: 2 minutes after end of test (n= 19, 23) | 0.41 score on a scale | Standard Deviation 0.72 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 20: Resting (n= 19, 21) | 0.05 score on a scale | Standard Deviation 0.16 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 20: End of Test (n= 18,22) | 2.31 score on a scale | Standard Deviation 1.7 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 20: 2 minutes after end of test (n= 18, 20) | 0.31 score on a scale | Standard Deviation 0.55 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 24: Resting (n= 20, 21) | 0.18 score on a scale | Standard Deviation 0.49 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 24: End of Test (n= 20, 21) | 2.58 score on a scale | Standard Deviation 1.87 |
| STI571 | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 24: 2 minutes after end of test (n= 20, 20) | 0.29 score on a scale | Standard Deviation 0.62 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 12: End of Test (n= 22, 25) | 2.92 score on a scale | Standard Deviation 1.95 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Baseline: Resting (n= 26, 27) | 0.43 score on a scale | Standard Deviation 0.92 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 24: Resting (n= 20, 21) | 0.40 score on a scale | Standard Deviation 0.82 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Baseline: End of Test (n= 27, 29) | 3.02 score on a scale | Standard Deviation 1.59 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 12: 2 minutes after end of test (n= 22, 23) | 0.65 score on a scale | Standard Deviation 1.06 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Baseline: 2 minutes after end of test (n=24, 26) | 1.08 score on a scale | Standard Deviation 1.47 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 20: End of Test (n= 18,22) | 3.11 score on a scale | Standard Deviation 2.17 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Day 32: Resting (n= 25, 27) | 0.48 score on a scale | Standard Deviation 0.86 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 16: Resting (n= 19, 23) | 0.50 score on a scale | Standard Deviation 1.23 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Day 32: End of Test (n= 25, 28) | 3.07 score on a scale | Standard Deviation 2.08 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 24: 2 minutes after end of test (n= 20, 20) | 0.67 score on a scale | Standard Deviation 1.07 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Day 32: 2 minutes after end of test (n= 25, 26) | 1.06 score on a scale | Standard Deviation 1.34 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 16: End of Test (n= 18, 23) | 2.83 score on a scale | Standard Deviation 1.69 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 8: Resting (n= 23, 24) | 0.38 score on a scale | Standard Deviation 0.81 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 20: 2 minutes after end of test (n= 18, 20) | 0.75 score on a scale | Standard Deviation 1.15 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 8: End of Test (n= 23, 25) | 2.32 score on a scale | Standard Deviation 1.64 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 16: 2 minutes after end of test (n= 19, 23) | 0.70 score on a scale | Standard Deviation 1.25 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 8: 2 minutes after end of test (n= 23, 24) | 0.58 score on a scale | Standard Deviation 1.04 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 24: End of Test (n= 20, 21) | 2.93 score on a scale | Standard Deviation 1.9 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 12: Resting (n= 22, 24) | 0.46 score on a scale | Standard Deviation 0.97 |
| Placebo | Borg Score During the Six Minutes Walk Test at Different Time Periods | Week 20: Resting (n= 19, 21) | 0.67 score on a scale | Standard Deviation 1.14 |
Secondary
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Heart Rate (bpm) were recorded before the test at resting, at the end of the test and two minutes after the end of the test
Time frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Baseline: Resting (n= 28, 29) | 80.8 beats per minute (bpm) | Standard Deviation 13 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Baseline: End of Test (n= 28, 29) | 106.3 beats per minute (bpm) | Standard Deviation 23.9 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Baseline: 2 minutes after end of test (n=26, 26) | 84.2 beats per minute (bpm) | Standard Deviation 16.9 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Day 32: Resting (n= 25, 28) | 80.7 beats per minute (bpm) | Standard Deviation 14.3 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Day 32: End of Test (n= 25, 28) | 108.4 beats per minute (bpm) | Standard Deviation 19.1 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Day 32: 2 minutes after end of test (n= 25, 26) | 89.2 beats per minute (bpm) | Standard Deviation 17 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 8: Resting (n= 23, 25) | 80.3 beats per minute (bpm) | Standard Deviation 9.6 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 8: End of Test (n= 23, 24) | 109.5 beats per minute (bpm) | Standard Deviation 21.4 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 8: 2 minutes after end of test (n= 23, 23) | 85.3 beats per minute (bpm) | Standard Deviation 15.7 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 12: Resting (n= 22, 25) | 76.5 beats per minute (bpm) | Standard Deviation 13.2 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 12: End of Test (n= 20, 25) | 105.3 beats per minute (bpm) | Standard Deviation 26.2 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 12: 2 minutes after end of test (n= 19, 22) | 83.8 beats per minute (bpm) | Standard Deviation 17.8 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 16: Resting (n= 19, 24) | 76.5 beats per minute (bpm) | Standard Deviation 13.2 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 16: End of Test (n= 18, 23) | 102.8 beats per minute (bpm) | Standard Deviation 25.6 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 16: 2 minutes after end of test (n= 19, 21) | 85.8 beats per minute (bpm) | Standard Deviation 21 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 20: Resting (n= 19, 22) | 75.3 beats per minute (bpm) | Standard Deviation 13.8 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 20: End of Test (n= 18,22) | 109.2 beats per minute (bpm) | Standard Deviation 26.8 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 20: 2 minutes after end of test (n= 19, 21) | 83.3 beats per minute (bpm) | Standard Deviation 17.4 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 24: Resting (n= 20, 22) | 79.5 beats per minute (bpm) | Standard Deviation 13.8 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 24: End of Test (n= 20, 21) | 110.2 beats per minute (bpm) | Standard Deviation 18.1 |
| STI571 | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 24: 2 minutes after end of test (n= 20, 21) | 87.9 beats per minute (bpm) | Standard Deviation 17.5 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 12: End of Test (n= 20, 25) | 113.0 beats per minute (bpm) | Standard Deviation 26.5 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Baseline: Resting (n= 28, 29) | 87.9 beats per minute (bpm) | Standard Deviation 12.7 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 24: Resting (n= 20, 22) | 83.6 beats per minute (bpm) | Standard Deviation 8.6 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Baseline: End of Test (n= 28, 29) | 112.3 beats per minute (bpm) | Standard Deviation 20.4 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 12: 2 minutes after end of test (n= 19, 22) | 89.4 beats per minute (bpm) | Standard Deviation 15.7 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Baseline: 2 minutes after end of test (n=26, 26) | 94.1 beats per minute (bpm) | Standard Deviation 14.6 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 20: End of Test (n= 18,22) | 118.0 beats per minute (bpm) | Standard Deviation 24.5 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Day 32: Resting (n= 25, 28) | 83.6 beats per minute (bpm) | Standard Deviation 15.7 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 16: Resting (n= 19, 24) | 84.4 beats per minute (bpm) | Standard Deviation 12.9 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Day 32: End of Test (n= 25, 28) | 113.1 beats per minute (bpm) | Standard Deviation 19.5 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 24: 2 minutes after end of test (n= 20, 21) | 88.9 beats per minute (bpm) | Standard Deviation 11.8 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Day 32: 2 minutes after end of test (n= 25, 26) | 90.6 beats per minute (bpm) | Standard Deviation 14.1 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 16: End of Test (n= 18, 23) | 117.9 beats per minute (bpm) | Standard Deviation 24.3 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 8: Resting (n= 23, 25) | 81.1 beats per minute (bpm) | Standard Deviation 11.2 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 20: 2 minutes after end of test (n= 19, 21) | 87.3 beats per minute (bpm) | Standard Deviation 11.4 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 8: End of Test (n= 23, 24) | 110.3 beats per minute (bpm) | Standard Deviation 26.4 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 16: 2 minutes after end of test (n= 19, 21) | 85.5 beats per minute (bpm) | Standard Deviation 14.4 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 8: 2 minutes after end of test (n= 23, 23) | 88.9 beats per minute (bpm) | Standard Deviation 13.2 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 24: End of Test (n= 20, 21) | 116.8 beats per minute (bpm) | Standard Deviation 21.7 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 12: Resting (n= 22, 25) | 85.1 beats per minute (bpm) | Standard Deviation 13.2 |
| Placebo | Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods | Week 20: Resting (n= 19, 22) | 80.2 beats per minute (bpm) | Standard Deviation 9.6 |
Secondary
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. The test was terminated if the patient became too distressed or if their SaO2% fell below 60%.
Time frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Baseline: Resting (n= 28, 29) | 94.3 Percentage of Oxygen Saturation | Standard Deviation 4.6 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Baseline: End of Test (n= 28, 28) | 87.9 Percentage of Oxygen Saturation | Standard Deviation 12.4 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Baseline: 2 minutes after end of test (n=26, 26) | 93.0 Percentage of Oxygen Saturation | Standard Deviation 7 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Day 32: Resting (n= 25, 28) | 94.5 Percentage of Oxygen Saturation | Standard Deviation 4 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Day 32: End of Test (n= 25, 28) | 89.0 Percentage of Oxygen Saturation | Standard Deviation 11.2 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Day 32: 2 minutes after end of test (n= 25, 26) | 94.8 Percentage of Oxygen Saturation | Standard Deviation 4.6 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 8: Resting (n= 23, 25) | 95.1 Percentage of Oxygen Saturation | Standard Deviation 3.3 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 8: End of Test (n= 23, 24) | 90.9 Percentage of Oxygen Saturation | Standard Deviation 6.7 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 8: 2 minutes after end of test (n= 23, 23) | 94.4 Percentage of Oxygen Saturation | Standard Deviation 5.3 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 12: Resting (n= 22, 25) | 95.1 Percentage of Oxygen Saturation | Standard Deviation 4.8 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 12: End of Test (n= 20, 24) | 89.8 Percentage of Oxygen Saturation | Standard Deviation 9.2 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 12: 2 minutes after end of test (n= 19, 22) | 92.7 Percentage of Oxygen Saturation | Standard Deviation 8.9 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 16: Resting (n= 19, 24) | 95.0 Percentage of Oxygen Saturation | Standard Deviation 5 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 16: End of Test (n= 18, 23) | 87.9 Percentage of Oxygen Saturation | Standard Deviation 13.1 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 16: 2 minutes after end of test (n= 19, 19) | 94.6 Percentage of Oxygen Saturation | Standard Deviation 6 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 20: Resting (n= 19, 22) | 94.0 Percentage of Oxygen Saturation | Standard Deviation 4.7 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 20: End of Test (n= 18, 21) | 87.5 Percentage of Oxygen Saturation | Standard Deviation 13.2 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 20: 2 minutes after end of test (n= 19, 21) | 93.8 Percentage of Oxygen Saturation | Standard Deviation 7.1 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 24: Resting (n= 20, 22) | 95.5 Percentage of Oxygen Saturation | Standard Deviation 3.4 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 24: End of Test (n= 20, 21) | 89.9 Percentage of Oxygen Saturation | Standard Deviation 7.1 |
| STI571 | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 24: 2 minutes after end of test (n= 20, 21) | 94.8 Percentage of Oxygen Saturation | Standard Deviation 4.3 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 12: End of Test (n= 20, 24) | 89.6 Percentage of Oxygen Saturation | Standard Deviation 8.9 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Baseline: Resting (n= 28, 29) | 93.4 Percentage of Oxygen Saturation | Standard Deviation 4.7 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 24: Resting (n= 20, 22) | 94.3 Percentage of Oxygen Saturation | Standard Deviation 4.6 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Baseline: End of Test (n= 28, 28) | 87.9 Percentage of Oxygen Saturation | Standard Deviation 8.2 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 12: 2 minutes after end of test (n= 19, 22) | 94.2 Percentage of Oxygen Saturation | Standard Deviation 5.6 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Baseline: 2 minutes after end of test (n=26, 26) | 92.0 Percentage of Oxygen Saturation | Standard Deviation 6.2 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 20: End of Test (n= 18, 21) | 87.6 Percentage of Oxygen Saturation | Standard Deviation 9.1 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Day 32: Resting (n= 25, 28) | 92.4 Percentage of Oxygen Saturation | Standard Deviation 6.3 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 16: Resting (n= 19, 24) | 94.1 Percentage of Oxygen Saturation | Standard Deviation 5.1 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Day 32: End of Test (n= 25, 28) | 87.2 Percentage of Oxygen Saturation | Standard Deviation 12.8 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 24: 2 minutes after end of test (n= 20, 21) | 94.8 Percentage of Oxygen Saturation | Standard Deviation 3.9 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Day 32: 2 minutes after end of test (n= 25, 26) | 92.7 Percentage of Oxygen Saturation | Standard Deviation 7.1 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 16: End of Test (n= 18, 23) | 88.1 Percentage of Oxygen Saturation | Standard Deviation 9.8 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 8: Resting (n= 23, 25) | 93.2 Percentage of Oxygen Saturation | Standard Deviation 6.1 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 20: 2 minutes after end of test (n= 19, 21) | 93.4 Percentage of Oxygen Saturation | Standard Deviation 7.4 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 8: End of Test (n= 23, 24) | 87.9 Percentage of Oxygen Saturation | Standard Deviation 11.9 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 16: 2 minutes after end of test (n= 19, 19) | 93.3 Percentage of Oxygen Saturation | Standard Deviation 8 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 8: 2 minutes after end of test (n= 23, 23) | 93.1 Percentage of Oxygen Saturation | Standard Deviation 7.8 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 24: End of Test (n= 20, 21) | 89.3 Percentage of Oxygen Saturation | Standard Deviation 8.4 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 12: Resting (n= 22, 25) | 93.9 Percentage of Oxygen Saturation | Standard Deviation 5.6 |
| Placebo | Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods | Week 20: Resting (n= 19, 22) | 93.7 Percentage of Oxygen Saturation | Standard Deviation 5 |
Secondary
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Systolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test
Time frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: Resting (n= 26, 28) | 111.3 mmHg | Standard Deviation 14.2 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: End of Test (n= 21, 26) | 119.9 mmHg | Standard Deviation 19.3 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: 2 minutes after end of test (n=25, 27) | 120.0 mmHg | Standard Deviation 18.3 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: Resting (n= 25, 27) | 111.4 mmHg | Standard Deviation 9.6 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: End of Test (n= 22, 22) | 126.5 mmHg | Standard Deviation 17.3 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: 2 minutes after end of test (n= 25, 26) | 119.6 mmHg | Standard Deviation 12.6 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: Resting (n= 22, 24) | 108.9 mmHg | Standard Deviation 12.3 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: End of Test (n= 19, 20) | 124.6 mmHg | Standard Deviation 16.1 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: 2 minutes after end of test (n= 23, 24) | 115.2 mmHg | Standard Deviation 13.6 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: Resting (n= 22, 23) | 106.5 mmHg | Standard Deviation 11.5 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: End of Test (n= 17, 19) | 122.2 mmHg | Standard Deviation 17 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: 2 minutes after end of test (n= 20, 22) | 115.9 mmHg | Standard Deviation 14.2 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: Resting (n= 19, 22) | 106.7 mmHg | Standard Deviation 9.7 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: End of Test (n= 15,18) | 117.2 mmHg | Standard Deviation 12.3 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: 2 minutes after end of test (n= 19, 22) | 114.6 mmHg | Standard Deviation 13.8 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: Resting (n= 19, 20) | 106.5 mmHg | Standard Deviation 7 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: End of Test (n= 16,17) | 122.4 mmHg | Standard Deviation 13.3 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: 2 minutes after end of test (n= 19, 20) | 115.5 mmHg | Standard Deviation 14 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: Resting (n= 20, 21) | 110.6 mmHg | Standard Deviation 15.6 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: End of Test (n= 16, 17) | 126.9 mmHg | Standard Deviation 23.6 |
| STI571 | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: 2 minutes after end of test (n= 20, 19) | 118.2 mmHg | Standard Deviation 18.6 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: End of Test (n= 17, 19) | 118.8 mmHg | Standard Deviation 22.9 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: Resting (n= 26, 28) | 104.6 mmHg | Standard Deviation 13.2 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: Resting (n= 20, 21) | 108.2 mmHg | Standard Deviation 15.7 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: End of Test (n= 21, 26) | 118.3 mmHg | Standard Deviation 18 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: 2 minutes after end of test (n= 20, 22) | 115.9 mmHg | Standard Deviation 14.9 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Baseline: 2 minutes after end of test (n=25, 27) | 110.4 mmHg | Standard Deviation 13.6 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: End of Test (n= 16,17) | 119.9 mmHg | Standard Deviation 19.3 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: Resting (n= 25, 27) | 106.0 mmHg | Standard Deviation 12.3 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: Resting (n= 19, 22) | 105.7 mmHg | Standard Deviation 12.5 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: End of Test (n= 22, 22) | 122.3 mmHg | Standard Deviation 18.6 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: 2 minutes after end of test (n= 20, 19) | 111.1 mmHg | Standard Deviation 10.6 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Day 32: 2 minutes after end of test (n= 25, 26) | 113.8 mmHg | Standard Deviation 14.9 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: End of Test (n= 15,18) | 119.8 mmHg | Standard Deviation 13.5 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: Resting (n= 22, 24) | 107.3 mmHg | Standard Deviation 13.5 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: 2 minutes after end of test (n= 19, 20) | 115.1 mmHg | Standard Deviation 15.1 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: End of Test (n= 19, 20) | 119.9 mmHg | Standard Deviation 17.1 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 16: 2 minutes after end of test (n= 19, 22) | 112.6 mmHg | Standard Deviation 15.8 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 8: 2 minutes after end of test (n= 23, 24) | 114.5 mmHg | Standard Deviation 13.7 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 24: End of Test (n= 16, 17) | 116.8 mmHg | Standard Deviation 14.9 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 12: Resting (n= 22, 23) | 107.7 mmHg | Standard Deviation 13.8 |
| Placebo | Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods | Week 20: Resting (n= 19, 20) | 109.1 mmHg | Standard Deviation 12.1 |
Secondary
Mean Cardiac Output (CO) at Baseline and Study Completion
The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Cardiac Output (CO). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline breathing ambient air (n=27,28) | 4.20 L/min | Standard Deviation 1.33 |
| STI571 | Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=19,20) | 4.02 L/min | Standard Deviation 1.32 |
| STI571 | Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,18) | 3.98 L/min | Standard Deviation 1.16 |
| STI571 | Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=19,14) | 4.20 L/min | Standard Deviation 1.16 |
| STI571 | Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=18,19) | 3.87 L/min | Standard Deviation 1.03 |
| STI571 | Mean Cardiac Output (CO) at Baseline and Study Completion | Week 24 breathing ambient air (n=20,22) | 4.90 L/min | Standard Deviation 1.21 |
| STI571 | Mean Cardiac Output (CO) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=10,13) | 4.80 L/min | Standard Deviation 1.26 |
| STI571 | Mean Cardiac Output (CO) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 4.79 L/min | Standard Deviation 1.31 |
| STI571 | Mean Cardiac Output (CO) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=10,12) | 4.63 L/min | Standard Deviation 1.21 |
| STI571 | Mean Cardiac Output (CO) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 4.48 L/min | Standard Deviation 1.21 |
| Placebo | Mean Cardiac Output (CO) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 4.62 L/min | Standard Deviation 2.26 |
| Placebo | Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline breathing ambient air (n=27,28) | 4.09 L/min | Standard Deviation 1.44 |
| Placebo | Mean Cardiac Output (CO) at Baseline and Study Completion | Week 24 breathing ambient air (n=20,22) | 4.35 L/min | Standard Deviation 1.57 |
| Placebo | Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=19,20) | 4.22 L/min | Standard Deviation 1.64 |
| Placebo | Mean Cardiac Output (CO) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 4.46 L/min | Standard Deviation 1.98 |
| Placebo | Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,18) | 4.43 L/min | Standard Deviation 1.8 |
| Placebo | Mean Cardiac Output (CO) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=10,13) | 4.67 L/min | Standard Deviation 2.27 |
| Placebo | Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=19,14) | 4.71 L/min | Standard Deviation 1.95 |
| Placebo | Mean Cardiac Output (CO) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=10,12) | 4.65 L/min | Standard Deviation 1.99 |
| Placebo | Mean Cardiac Output (CO) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=18,19) | 4.47 L/min | Standard Deviation 2.15 |
Secondary
Mean Heart Rate (HR) at Baseline and Study Completion
The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Heart Rate (HR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Mean Heart Rate (HR) at Baseline and Study Completion | Baseline breathing ambient air (n=27,28) | 77.3 beats per minute (bpm) | Standard Deviation 7.5 |
| STI571 | Mean Heart Rate (HR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=20,19) | 75.9 beats per minute (bpm) | Standard Deviation 12.9 |
| STI571 | Mean Heart Rate (HR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,17) | 75.2 beats per minute (bpm) | Standard Deviation 13.6 |
| STI571 | Mean Heart Rate (HR) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=19,15) | 73.2 beats per minute (bpm) | Standard Deviation 10.2 |
| STI571 | Mean Heart Rate (HR) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=18,19) | 76.2 beats per minute (bpm) | Standard Deviation 9 |
| STI571 | Mean Heart Rate (HR) at Baseline and Study Completion | Week 24 breathing ambient air (n=20,22) | 76.6 beats per minute (bpm) | Standard Deviation 8.6 |
| STI571 | Mean Heart Rate (HR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=9,13) | 76.3 beats per minute (bpm) | Standard Deviation 10.1 |
| STI571 | Mean Heart Rate (HR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=8,11) | 76.6 beats per minute (bpm) | Standard Deviation 10.3 |
| STI571 | Mean Heart Rate (HR) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=9,12) | 75.7 beats per minute (bpm) | Standard Deviation 10.2 |
| STI571 | Mean Heart Rate (HR) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 73.2 beats per minute (bpm) | Standard Deviation 8.3 |
| Placebo | Mean Heart Rate (HR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=8,11) | 82.8 beats per minute (bpm) | Standard Deviation 16.7 |
| Placebo | Mean Heart Rate (HR) at Baseline and Study Completion | Baseline breathing ambient air (n=27,28) | 84.9 beats per minute (bpm) | Standard Deviation 13 |
| Placebo | Mean Heart Rate (HR) at Baseline and Study Completion | Week 24 breathing ambient air (n=20,22) | 83.0 beats per minute (bpm) | Standard Deviation 12.8 |
| Placebo | Mean Heart Rate (HR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=20,19) | 84.4 beats per minute (bpm) | Standard Deviation 15.5 |
| Placebo | Mean Heart Rate (HR) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 82.9 beats per minute (bpm) | Standard Deviation 10.5 |
| Placebo | Mean Heart Rate (HR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,17) | 83.3 beats per minute (bpm) | Standard Deviation 13.2 |
| Placebo | Mean Heart Rate (HR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=9,13) | 82.5 beats per minute (bpm) | Standard Deviation 15.3 |
| Placebo | Mean Heart Rate (HR) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=19,15) | 84.3 beats per minute (bpm) | Standard Deviation 13.9 |
| Placebo | Mean Heart Rate (HR) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=9,12) | 79.3 beats per minute (bpm) | Standard Deviation 10.4 |
| Placebo | Mean Heart Rate (HR) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=18,19) | 85.1 beats per minute (bpm) | Standard Deviation 13.8 |
Secondary
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including right Pulmonary Arterial Pressure (PAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline breathing ambient air (n=27,28) | 61.7 mmHg | Standard Deviation 15.6 |
| STI571 | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=20,20) | 61.6 mmHg | Standard Deviation 18.7 |
| STI571 | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,18) | 58.1 mmHg | Standard Deviation 16.7 |
| STI571 | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=20,14) | 60.9 mmHg | Standard Deviation 16.2 |
| STI571 | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=19,19) | 60.3 mmHg | Standard Deviation 16 |
| STI571 | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Week 24 breathing ambient air (n=20,22) | 52.5 mmHg | Standard Deviation 11.4 |
| STI571 | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=10,13) | 50.9 mmHg | Standard Deviation 17.5 |
| STI571 | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 46.2 mmHg | Standard Deviation 18.1 |
| STI571 | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=10,12) | 47.0 mmHg | Standard Deviation 15.8 |
| STI571 | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 48.1 mmHg | Standard Deviation 13.7 |
| Placebo | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 53.9 mmHg | Standard Deviation 14.1 |
| Placebo | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline breathing ambient air (n=27,28) | 59.2 mmHg | Standard Deviation 11.6 |
| Placebo | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Week 24 breathing ambient air (n=20,22) | 55.5 mmHg | Standard Deviation 11.6 |
| Placebo | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=20,20) | 55.7 mmHg | Standard Deviation 12 |
| Placebo | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 57.2 mmHg | Standard Deviation 12.4 |
| Placebo | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,18) | 53.3 mmHg | Standard Deviation 11.5 |
| Placebo | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=10,13) | 55.1 mmHg | Standard Deviation 13.9 |
| Placebo | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=20,14) | 56.9 mmHg | Standard Deviation 10.8 |
| Placebo | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=10,12) | 57.5 mmHg | Standard Deviation 12.8 |
| Placebo | Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=19,19) | 56.5 mmHg | Standard Deviation 10.3 |
Secondary
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Arterial Wedge Pressure (PAWP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline breathing ambient air (n=26,28) | 9.0 mmHg | Standard Deviation 2.6 |
| STI571 | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=20,17) | 9.5 mmHg | Standard Deviation 2 |
| STI571 | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,16) | 9.4 mmHg | Standard Deviation 2.2 |
| STI571 | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=19,12) | 9.5 mmHg | Standard Deviation 2.7 |
| STI571 | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=18,17) | 9.6 mmHg | Standard Deviation 2.4 |
| STI571 | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Week 24 breathing ambient air (n=19,22) | 8.4 mmHg | Standard Deviation 3.2 |
| STI571 | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=9,13) | 7.9 mmHg | Standard Deviation 3.1 |
| STI571 | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 7.0 mmHg | Standard Deviation 3.4 |
| STI571 | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=10,12) | 7.1 mmHg | Standard Deviation 3.1 |
| STI571 | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 6.7 mmHg | Standard Deviation 2.8 |
| Placebo | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 10.0 mmHg | Standard Deviation 3.7 |
| Placebo | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline breathing ambient air (n=26,28) | 7.6 mmHg | Standard Deviation 2.3 |
| Placebo | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Week 24 breathing ambient air (n=19,22) | 8.6 mmHg | Standard Deviation 2.8 |
| Placebo | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=20,17) | 7.7 mmHg | Standard Deviation 2.9 |
| Placebo | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 10.4 mmHg | Standard Deviation 3.6 |
| Placebo | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,16) | 7.8 mmHg | Standard Deviation 3.4 |
| Placebo | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=9,13) | 10.2 mmHg | Standard Deviation 3.7 |
| Placebo | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=19,12) | 7.8 mmHg | Standard Deviation 2.9 |
| Placebo | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=10,12) | 10.3 mmHg | Standard Deviation 3.3 |
| Placebo | Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=18,17) | 8.1 mmHg | Standard Deviation 2.6 |
Secondary
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. PVR calculated according to the equation:PVR = (PAP - PCWP)/CO
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline breathing ambient air (n=27,27) | 1124.4 dyn*s/cm^5 | Standard Deviation 460 |
| STI571 | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=19,17) | 1180.9 dyn*s/cm^5 | Standard Deviation 520.8 |
| STI571 | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,16) | 1064.6 dyn*s/cm^5 | Standard Deviation 458.9 |
| STI571 | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=19,11) | 1131.5 dyn*s/cm^5 | Standard Deviation 491.2 |
| STI571 | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=18,16) | 1181.9 dyn*s/cm^5 | Standard Deviation 498.7 |
| STI571 | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Week 24 breathing ambient air (n=19,21) | 729.9 dyn*s/cm^5 | Standard Deviation 230.1 |
| STI571 | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=9,14) | 706.9 dyn*s/cm^5 | Standard Deviation 285.5 |
| STI571 | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 687.4 dyn*s/cm^5 | Standard Deviation 276.3 |
| STI571 | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=10,12) | 717.2 dyn*s/cm^5 | Standard Deviation 271.6 |
| STI571 | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 776.1 dyn*s/cm^5 | Standard Deviation 286.8 |
| Placebo | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 1033.6 dyn*s/cm^5 | Standard Deviation 546.2 |
| Placebo | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline breathing ambient air (n=27,27) | 1118.3 dyn*s/cm^5 | Standard Deviation 486.7 |
| Placebo | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Week 24 breathing ambient air (n=19,21) | 1017.0 dyn*s/cm^5 | Standard Deviation 369.1 |
| Placebo | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=19,17) | 1067.9 dyn*s/cm^5 | Standard Deviation 509.1 |
| Placebo | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 1042.5 dyn*s/cm^5 | Standard Deviation 388.4 |
| Placebo | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,16) | 982.8 dyn*s/cm^5 | Standard Deviation 483.9 |
| Placebo | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=9,14) | 1000.6 dyn*s/cm^5 | Standard Deviation 501.5 |
| Placebo | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=19,11) | 1160.4 dyn*s/cm^5 | Standard Deviation 510 |
| Placebo | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=10,12) | 987.8 dyn*s/cm^5 | Standard Deviation 370.4 |
| Placebo | Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=18,16) | 1132.9 dyn*s/cm^5 | Standard Deviation 461 |
Secondary
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systemic Vascular Resistance (SVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. SVR was calculated according to the equation: SVR = (Paorta - Pright atrium)/CO
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline breathing ambient air (n=26,26) | 1674.4 dyn*s/cm^5 | Standard Deviation 761.2 |
| STI571 | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=18,15) | 1778.2 dyn*s/cm^5 | Standard Deviation 709.5 |
| STI571 | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=16,14) | 1807.3 dyn*s/cm^5 | Standard Deviation 615.1 |
| STI571 | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=18,11) | 1609.2 dyn*s/cm^5 | Standard Deviation 593.4 |
| STI571 | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=17,15) | 1976.3 dyn*s/cm^5 | Standard Deviation 877.5 |
| STI571 | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Week 24 breathing ambient air (n=18,21) | 1427.2 dyn*s/cm^5 | Standard Deviation 446.8 |
| STI571 | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=9,13) | 1344.2 dyn*s/cm^5 | Standard Deviation 474.8 |
| STI571 | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 1367.9 dyn*s/cm^5 | Standard Deviation 601.7 |
| STI571 | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=9,12) | 1419.7 dyn*s/cm^5 | Standard Deviation 566.6 |
| STI571 | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 1431.7 dyn*s/cm^5 | Standard Deviation 524.4 |
| Placebo | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 1592.5 dyn*s/cm^5 | Standard Deviation 389 |
| Placebo | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline breathing ambient air (n=26,26) | 1764.8 dyn*s/cm^5 | Standard Deviation 481.9 |
| Placebo | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Week 24 breathing ambient air (n=18,21) | 1667.9 dyn*s/cm^5 | Standard Deviation 357.8 |
| Placebo | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=18,15) | 1769.7 dyn*s/cm^5 | Standard Deviation 457 |
| Placebo | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 1629.3 dyn*s/cm^5 | Standard Deviation 355.6 |
| Placebo | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=16,14) | 1664.7 dyn*s/cm^5 | Standard Deviation 472 |
| Placebo | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=9,13) | 1579.3 dyn*s/cm^5 | Standard Deviation 386.8 |
| Placebo | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=18,11) | 1666.6 dyn*s/cm^5 | Standard Deviation 488.6 |
| Placebo | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=9,12) | 1503.9 dyn*s/cm^5 | Standard Deviation 305.3 |
| Placebo | Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=17,15) | 1748.4 dyn*s/cm^5 | Standard Deviation 499.3 |
Secondary
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systolic Arterial Pressure (SAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.
Time frame: Baseline, and Study completion (Week 24)
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STI571 | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline breathing ambient air (n=26,28) | 110.3 mmHg | Standard Deviation 19.5 |
| STI571 | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=20,19) | 108.3 mmHg | Standard Deviation 18.9 |
| STI571 | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,17) | 109.9 mmHg | Standard Deviation 19.1 |
| STI571 | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=21,15) | 106.0 mmHg | Standard Deviation 17.7 |
| STI571 | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=19,19) | 109.5 mmHg | Standard Deviation 20.3 |
| STI571 | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Week 24 breathing ambient air (n=20,22) | 108.0 mmHg | Standard Deviation 19.8 |
| STI571 | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=10,13) | 103.9 mmHg | Standard Deviation 17.5 |
| STI571 | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 104.8 mmHg | Standard Deviation 18.3 |
| STI571 | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=9,12) | 103.4 mmHg | Standard Deviation 18.7 |
| STI571 | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 103.8 mmHg | Standard Deviation 21.4 |
| Placebo | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (2nd) (n=9,11) | 103.6 mmHg | Standard Deviation 19.2 |
| Placebo | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline breathing ambient air (n=26,28) | 108.2 mmHg | Standard Deviation 15.4 |
| Placebo | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Week 24 breathing ambient air (n=20,22) | 106.9 mmHg | Standard Deviation 18.8 |
| Placebo | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (1st) (n=20,19) | 106.9 mmHg | Standard Deviation 18 |
| Placebo | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Week 24 15 mins after NO administration (n=10,14) | 107.3 mmHg | Standard Deviation 18.3 |
| Placebo | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline every 2 mins breathing NO (2nd) (n=17,17) | 105.4 mmHg | Standard Deviation 18.1 |
| Placebo | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Week 24 every 2 mins breathing NO (1st) (n=10,13) | 102.9 mmHg | Standard Deviation 20.4 |
| Placebo | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline 5 mins after NO administration (n=21,15) | 107.1 mmHg | Standard Deviation 18.6 |
| Placebo | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Week 24 5 mins after NO administration (n=9,12) | 104.0 mmHg | Standard Deviation 20 |
| Placebo | Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion | Baseline 15 mins after NO administration(n=19,19) | 106.9 mmHg | Standard Deviation 16.7 |
Secondary
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
PAH assessed according to the WHO classification: Class I Patients with PAH but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PAH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PAH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PAH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.
Time frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion
Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Baseline: WHO Class IV (n=27,30) | 2 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Baseline: WHO Class III (n=27,30) | 14 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Baseline: WHO Class II (n=27,30) | 11 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Day 32: WHO Class IV (n=27,30) | 3 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Day 32: WHO Class III (n=27,30) | 11 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Day 32: WHO Class II (n=27,30) | 13 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 8: WHO Class IV (n=24,27) | 3 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 8: WHO Class III (n=24,27) | 9 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 8: WHO Class II (n=24,27) | 12 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 12: WHO Class IV (n=23,27) | 0 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 12: WHO Class III (n=23,27) | 12 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 12: WHO Class II (n=23,27) | 11 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 16: WHO Class IV (n=22,27) | 0 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 16: WHO Class III (n=22,27) | 11 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 16: WHO Class II (n=22,27) | 11 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 16: WHO Class I (n=22,27) | 0 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 20: WHO Class IV (n=19,24) | 0 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 20: WHO Class III (n=19,24) | 10 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 20: WHO Class II (n=19,24) | 8 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 20: WHO Class I (n=19,24) | 1 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 24: WHO Class IV (n=21,25) | 1 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 24: WHO Class III (n=21,25) | 12 number of participants |
| STI571 | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 24: WHO Class II (n=21,25) | 8 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 12: WHO Class II (n=23,27) | 9 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Baseline: WHO Class IV (n=27,30) | 1 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 20: WHO Class III (n=19,24) | 14 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Baseline: WHO Class III (n=27,30) | 22 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 16: WHO Class IV (n=22,27) | 1 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Baseline: WHO Class II (n=27,30) | 7 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 24: WHO Class IV (n=21,25) | 2 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Day 32: WHO Class IV (n=27,30) | 3 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 16: WHO Class III (n=22,27) | 18 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Day 32: WHO Class III (n=27,30) | 21 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 20: WHO Class II (n=19,24) | 9 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Day 32: WHO Class II (n=27,30) | 6 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 16: WHO Class II (n=22,27) | 7 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 8: WHO Class IV (n=24,27) | 1 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 24: WHO Class II (n=21,25) | 10 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 8: WHO Class III (n=24,27) | 20 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 16: WHO Class I (n=22,27) | 1 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 8: WHO Class II (n=24,27) | 6 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 20: WHO Class I (n=19,24) | 0 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 12: WHO Class IV (n=23,27) | 1 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 20: WHO Class IV (n=19,24) | 1 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 12: WHO Class III (n=23,27) | 17 number of participants |
| Placebo | Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity | Week 24: WHO Class III (n=21,25) | 13 number of participants |