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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005569-12 |
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This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STI571 | Experimental | STI571 |
|
| Placebo | Placebo Comparator | Placebo |
|
| All Patients | Experimental | Open label extension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib mesylate | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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. | 72 months |
| 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. | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
| 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. | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis | Investigative site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Los Angeles | California | 90073 | United States | ||
| Novartis investigative site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20581169 | Derived | Ghofrani HA, Morrell NW, Hoeper MM, Olschewski H, Peacock AJ, Barst RJ, Shapiro S, Golpon H, Toshner M, Grimminger F, Pascoe S. Imatinib in pulmonary arterial hypertension patients with inadequate response to established therapy. Am J Respir Crit Care Med. 2010 Nov 1;182(9):1171-7. doi: 10.1164/rccm.201001-0123OC. Epub 2010 Jun 25. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | STI571 | STI571 |
| FG001 | Placebo | Placebo |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Study |
|
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| Placebo |
| Drug |
|
| Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
| Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion |
| 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%. | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
| 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 | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
| 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 | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
| 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 | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
| 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 | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| 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 | Baseline, and Study completion (Week 24) |
| 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 | Baseline, and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| 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. | Baseline, and Study completion (Week 24) |
| Newark |
| New Jersey |
| 07112 |
| United States |
| Novartis Investigative Site | New York | New York | 10032 | United States |
| Novartis Investigative Site | Graz | Austria | A-8036 | Austria |
| Novartis Investigative site | Graz | Austria |
| Novartis Investigative Site | Hanover | Germany | 30625 | Germany |
| Novartis Investigative Site | Giessen | 35385 | Germany |
| Novartis Investigative site | Giessen | Germany |
| Novartis Investigative site | Hanover | Germany |
| Novartis Investigative Site | Cambridge | Cambridgeshire | CB23 3RE | United Kingdom |
| Novartis Investigative Site | Glasgow | G11 6NT | United Kingdom |
| Novartis Investigative site | Glasgow | United Kingdom |
| Novartis Investigative site | Papworth Everard | United Kingdom |
| All Patients |
Open label extension |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open Label Extension |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | STI571 | STI571 |
| BG001 | Placebo | Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of 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. | Safety Population all participants enrolled was included in this population | Posted | Number | participants | 6 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | participants | 72 months |
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| |||||||||||||||||||||||||||||||||||||
| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | meters | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | number of stops | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | minutes | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Number | number of participants | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion |
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| 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%. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | Percentage of Oxygen Saturation | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
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| 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 | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
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| 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 | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
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| 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 | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
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| 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 | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | mmHg | Baseline, and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | mmHg | Baseline, and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | mmHg | Baseline, and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline, and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | L/min | Baseline, and Study completion (Week 24) |
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| 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 | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | dyn*s/cm^5 | Baseline, and Study completion (Week 24) |
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| 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 | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | dyn*s/cm^5 | Baseline, and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | mmHg | Baseline, and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | mmHg | Baseline, and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | mmHg | Baseline, and Study completion (Week 24) |
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | percentage of saturation | Baseline, and Study completion (Week 24) |
|
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | percentage of saturation | Baseline, and Study completion (Week 24) |
|
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| 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. | The intention to treat population (ITT) will include all patients who received at least one dose of study medication. | Posted | Mean | Standard Deviation | pH scale | Baseline, and Study completion (Week 24) |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Core - STI571 | Core - STI571 | 12 | 28 | 26 | 28 | ||
| EG001 | Core - Placebo | Core - Placebo | 11 | 31 | 25 | 31 | ||
| EG002 | Extension - STI571 | Extension - STI571 | 16 | 22 | 21 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary artery aneurysm | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Tonsillectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Arterial rupture | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Exercise tolerance decreased | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood amylase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| unsatisfactory therapeutic effects |
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| Adminiatrative problems |
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| Death |
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| Male |
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| SAE(s) |
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| Units | Counts |
|---|---|
| Participants |
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