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Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00477269
Recruitment Status : Completed
First Posted : May 23, 2007
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Interventions Drug: Imatinib mesylate
Drug: Placebo
Enrollment 59
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.
Pre-assignment Details  
Arm/Group Title STI571 Placebo All Patients
Hide Arm/Group Description STI571 Placebo Open label extension
Period Title: Core Study
Started 28 31 0
Completed 19 23 0
Not Completed 9 8 0
Reason Not Completed
Adverse Event             6             4             0
Death             3             3             0
Withdrawn Consent             0             1             0
Period Title: Open Label Extension
Started 0 [1] 0 [1] 22
Completed 0 [1] 0 [1] 9
Not Completed 0 0 13
Reason Not Completed
Adverse Event             0             0             4
Abnormal laboratory values             0             0             1
unsatisfactory therapeutic effects             0             0             2
Adminiatrative problems             0             0             2
Death             0             0             4
[1]
Arm in the Core study not extension
Arm/Group Title STI571 Placebo Total
Hide Arm/Group Description STI571 Placebo Total of all reporting groups
Overall Number of Baseline Participants 28 31 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 31 participants 59 participants
44.4  (15.3) 44.2  (15.7) 44.3  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 31 participants 59 participants
Female
18
  64.3%
22
  71.0%
40
  67.8%
Male
10
  35.7%
9
  29.0%
19
  32.2%
1.Primary Outcome
Title Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core
Hide Description In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.
Time Frame 6 months
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Hide Analysis Population Description
Safety Population all participants enrolled was included in this population
Arm/Group Title STI571 Placebo
Hide Arm/Group Description:
STI571
Placebo
Overall Number of Participants Analyzed 28 31
Measure Type: Number
Unit of Measure: participants
Paients with AE(s) 27 29
Death 3 3
SAE(s) 12 11
2.Primary Outcome
Title Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension
Hide Description In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Patients
Hide Arm/Group Description:
Open label extension
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
Any AE(s) 22
Death 4
SAE(s) 16
3.Primary Outcome
Title Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods
Hide Description 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)
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Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
Arm/Group Title STI571 Placebo
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STI571
Placebo
Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: meters
Day 32 (n=25,27) 10.2  (53.7) 8.2  (27.5)
week 8 (n=23,24) 17.0  (55.6) 15.5  (40.8)
week 12 (n=22,24) 21  (36.2) 7.8  (50.0)
week 16 (n=19, 23) 25.5  (43.1) 12.1  (47.9)
week 20 (n=19, 21) 38.3  (42.5) 12.8  (60.4)
study completion Week 24 (n=21, 12) 22.0  (63.1) -1.0  (53.3)
4.Primary Outcome
Title Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
Arm/Group Title STI571 Placebo
Hide Arm/Group Description:
STI571
Placebo
Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: number of stops
Day 32 (n=25,27) -0.2  (0.7) 0.1  (0.4)
week 8 (n=23,24) -0.2  (0.7) 0.0  (1.1)
week 12 (n=22,24) -0.3  (0.9) 0.3  (0.9)
week 16 (n=19, 23) -0.3  (0.8) 0.0  (0.2)
week 20 (n=19, 21) -0.4  (1.0) 0.3  (1.0)
study completion Week 24 (n=21, 12) -0.3  (0.8) -0.1  (0.5)
5.Primary Outcome
Title Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
Arm/Group Title STI571 Placebo
Hide Arm/Group Description:
STI571
Placebo
Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: minutes
Day 32 (n=25,27) -0.06  (0.19) 0.12  (0.36)
week 8 (n=23,24) -0.03  (0.10) 0.07  (0.27)
week 12 (n=22,24) -0.03  (0.10) 0.19  (0.55)
week 16 (n=19, 23) -0.03  (0.10) 0.06  (0.26)
week 20 (n=19, 21) -0.05  (0.15) 0.12  (0.42)
study completion Week 24 (n=21, 12) -0.02  (0.10) 0.03  (0.18)
6.Secondary Outcome
Title Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
Arm/Group Title STI571 Placebo
Hide Arm/Group Description:
STI571
Placebo
Overall Number of Participants Analyzed 28 31
Measure Type: Number
Unit of Measure: number of participants
Baseline: WHO Class IV (n=27,30) 2 1
Baseline: WHO Class III (n=27,30) 14 22
Baseline: WHO Class II (n=27,30) 11 7
Day 32: WHO Class IV (n=27,30) 3 3
Day 32: WHO Class III (n=27,30) 11 21
Day 32: WHO Class II (n=27,30) 13 6
Week 8: WHO Class IV (n=24,27) 3 1
Week 8: WHO Class III (n=24,27) 9 20
Week 8: WHO Class II (n=24,27) 12 6
Week 12: WHO Class IV (n=23,27) 0 1
Week 12: WHO Class III (n=23,27) 12 17
Week 12: WHO Class II (n=23,27) 11 9
Week 16: WHO Class IV (n=22,27) 0 1
Week 16: WHO Class III (n=22,27) 11 18
Week 16: WHO Class II (n=22,27) 11 7
Week 16: WHO Class I (n=22,27) 0 1
Week 20: WHO Class IV (n=19,24) 0 1
Week 20: WHO Class III (n=19,24) 10 14
Week 20: WHO Class II (n=19,24) 8 9
Week 20: WHO Class I (n=19,24) 1 0
Week 24: WHO Class IV (n=21,25) 1 2
Week 24: WHO Class III (n=21,25) 12 13
Week 24: WHO Class II (n=21,25) 8 10
7.Secondary Outcome
Title Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
Arm/Group Title STI571 Placebo
Hide Arm/Group Description:
STI571
Placebo
Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: Percentage of Oxygen Saturation
Baseline: Resting (n= 28, 29) 94.3  (4.6) 93.4  (4.7)
Baseline: End of Test (n= 28, 28) 87.9  (12.4) 87.9  (8.2)
Baseline: 2 minutes after end of test (n=26, 26) 93.0  (7.0) 92.0  (6.2)
Day 32: Resting (n= 25, 28) 94.5  (4.0) 92.4  (6.3)
Day 32: End of Test (n= 25, 28) 89.0  (11.2) 87.2  (12.8)
Day 32: 2 minutes after end of test (n= 25, 26) 94.8  (4.6) 92.7  (7.1)
Week 8: Resting (n= 23, 25) 95.1  (3.3) 93.2  (6.1)
Week 8: End of Test (n= 23, 24) 90.9  (6.7) 87.9  (11.9)
Week 8: 2 minutes after end of test (n= 23, 23) 94.4  (5.3) 93.1  (7.8)
Week 12: Resting (n= 22, 25) 95.1  (4.8) 93.9  (5.6)
Week 12: End of Test (n= 20, 24) 89.8  (9.2) 89.6  (8.9)
Week 12: 2 minutes after end of test (n= 19, 22) 92.7  (8.9) 94.2  (5.6)
Week 16: Resting (n= 19, 24) 95.0  (5.0) 94.1  (5.1)
Week 16: End of Test (n= 18, 23) 87.9  (13.1) 88.1  (9.8)
Week 16: 2 minutes after end of test (n= 19, 19) 94.6  (6.0) 93.3  (8.0)
Week 20: Resting (n= 19, 22) 94.0  (4.7) 93.7  (5.0)
Week 20: End of Test (n= 18, 21) 87.5  (13.2) 87.6  (9.1)
Week 20: 2 minutes after end of test (n= 19, 21) 93.8  (7.1) 93.4  (7.4)
Week 24: Resting (n= 20, 22) 95.5  (3.4) 94.3  (4.6)
Week 24: End of Test (n= 20, 21) 89.9  (7.1) 89.3  (8.4)
Week 24: 2 minutes after end of test (n= 20, 21) 94.8  (4.3) 94.8  (3.9)
8.Secondary Outcome
Title Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
Arm/Group Title STI571 Placebo
Hide Arm/Group Description:
STI571
Placebo
Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline: Resting (n= 26, 28) 111.3  (14.2) 104.6  (13.2)
Baseline: End of Test (n= 21, 26) 119.9  (19.3) 118.3  (18.0)
Baseline: 2 minutes after end of test (n=25, 27) 120.0  (18.3) 110.4  (13.6)
Day 32: Resting (n= 25, 27) 111.4  (9.6) 106.0  (12.3)
Day 32: End of Test (n= 22, 22) 126.5  (17.3) 122.3  (18.6)
Day 32: 2 minutes after end of test (n= 25, 26) 119.6  (12.6) 113.8  (14.9)
Week 8: Resting (n= 22, 24) 108.9  (12.3) 107.3  (13.5)
Week 8: End of Test (n= 19, 20) 124.6  (16.1) 119.9  (17.1)
Week 8: 2 minutes after end of test (n= 23, 24) 115.2  (13.6) 114.5  (13.7)
Week 12: Resting (n= 22, 23) 106.5  (11.5) 107.7  (13.8)
Week 12: End of Test (n= 17, 19) 122.2  (17.0) 118.8  (22.9)
Week 12: 2 minutes after end of test (n= 20, 22) 115.9  (14.2) 115.9  (14.9)
Week 16: Resting (n= 19, 22) 106.7  (9.7) 105.7  (12.5)
Week 16: End of Test (n= 15,18) 117.2  (12.3) 119.8  (13.5)
Week 16: 2 minutes after end of test (n= 19, 22) 114.6  (13.8) 112.6  (15.8)
Week 20: Resting (n= 19, 20) 106.5  (7.0) 109.1  (12.1)
Week 20: End of Test (n= 16,17) 122.4  (13.3) 119.9  (19.3)
Week 20: 2 minutes after end of test (n= 19, 20) 115.5  (14.0) 115.1  (15.1)
Week 24: Resting (n= 20, 21) 110.6  (15.6) 108.2  (15.7)
Week 24: End of Test (n= 16, 17) 126.9  (23.6) 116.8  (14.9)
Week 24: 2 minutes after end of test (n= 20, 19) 118.2  (18.6) 111.1  (10.6)
9.Secondary Outcome
Title Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
Arm/Group Title STI571 Placebo
Hide Arm/Group Description:
STI571
Placebo
Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline: Resting (n= 26, 28) 68.2  (10.2) 67.9  (8.9)
Baseline: End of Test (n= 21, 26) 75.1  (10.8) 69.5  (11.9)
Baseline: 2 minutes after end of test (n=25, 27) 71.6  (9.8) 67.9  (9.6)
Day 32: Resting (n= 25, 27) 69.6  (10.4) 68.4  (8.8)
Day 32: End of Test (n= 22, 22) 78.2  (12.3) 75.2  (11.2)
Day 32: 2 minutes after end of test (n= 25, 26) 72.5  (9.1) 70.7  (9.4)
Week 8: Resting (n= 22, 24) 67.7  (11.8) 68.8  (9.0)
Week 8: End of Test (n= 19, 20) 74.8  (10.8) 74.0  (10.9)
Week 8: 2 minutes after end of test (n= 23, 24) 71.2  (10.3) 72.2  (11.7)
Week 12: Resting (n= 22, 23) 65.5  (8.3) 70.6  (11.6)
Week 12: End of Test (n= 17, 19) 75.6  (11.5) 72.4  (14.3)
Week 12: 2 minutes after end of test (n= 20, 22) 73.1  (8.9) 72.0  (13.7)
Week 16: Resting (n= 19, 22) 67.7  (9.9) 66.7  (7.7)
Week 16: End of Test (n= 15,18) 72.7  (9.2) 76.7  (8.6)
Week 16: 2 minutes after end of test (n= 19, 22) 71.4  (11.0) 70.5  (8.0)
Week 20: Resting (n= 19, 20) 67.2  (8.0) 69.8  (8.8)
Week 20: End of Test (n= 16,17) 72.9  (8.7) 72.9  (8.1)
Week 20: 2 minutes after end of test (n= 19, 20) 71.9  (9.2) 72.7  (9.8)
Week 24: Resting (n= 20, 21) 69.7  (10.3) 70.7  (10.9)
Week 24: End of Test (n= 16, 17) 74.1  (10.7) 72.3  (10.9)
Week 24: 2 minutes after end of test (n= 20, 19) 71.3  (10.1) 72.9  (9.5)
10.Secondary Outcome
Title Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
Arm/Group Title STI571 Placebo
Hide Arm/Group Description:
STI571
Placebo
Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Baseline: Resting (n= 28, 29) 80.8  (13.0) 87.9  (12.7)
Baseline: End of Test (n= 28, 29) 106.3  (23.9) 112.3  (20.4)
Baseline: 2 minutes after end of test (n=26, 26) 84.2  (16.9) 94.1  (14.6)
Day 32: Resting (n= 25, 28) 80.7  (14.3) 83.6  (15.7)
Day 32: End of Test (n= 25, 28) 108.4  (19.1) 113.1  (19.5)
Day 32: 2 minutes after end of test (n= 25, 26) 89.2  (17.0) 90.6  (14.1)
Week 8: Resting (n= 23, 25) 80.3  (9.6) 81.1  (11.2)
Week 8: End of Test (n= 23, 24) 109.5  (21.4) 110.3  (26.4)
Week 8: 2 minutes after end of test (n= 23, 23) 85.3  (15.7) 88.9  (13.2)
Week 12: Resting (n= 22, 25) 76.5  (13.2) 85.1  (13.2)
Week 12: End of Test (n= 20, 25) 105.3  (26.2) 113.0  (26.5)
Week 12: 2 minutes after end of test (n= 19, 22) 83.8  (17.8) 89.4  (15.7)
Week 16: Resting (n= 19, 24) 76.5  (13.2) 84.4  (12.9)
Week 16: End of Test (n= 18, 23) 102.8  (25.6) 117.9  (24.3)
Week 16: 2 minutes after end of test (n= 19, 21) 85.8  (21.0) 85.5  (14.4)
Week 20: Resting (n= 19, 22) 75.3  (13.8) 80.2  (9.6)
Week 20: End of Test (n= 18,22) 109.2  (26.8) 118.0  (24.5)
Week 20: 2 minutes after end of test (n= 19, 21) 83.3  (17.4) 87.3  (11.4)
Week 24: Resting (n= 20, 22) 79.5  (13.8) 83.6  (8.6)
Week 24: End of Test (n= 20, 21) 110.2  (18.1) 116.8  (21.7)
Week 24: 2 minutes after end of test (n= 20, 21) 87.9  (17.5) 88.9  (11.8)
11.Secondary Outcome
Title Borg Score During the Six Minutes Walk Test at Different Time Periods
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
Arm/Group Title STI571 Placebo
Hide Arm/Group Description:
STI571
Placebo
Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline: Resting (n= 26, 27) 0.27  (0.83) 0.43  (0.92)
Baseline: End of Test (n= 27, 29) 3.34  (2.30) 3.02  (1.59)
Baseline: 2 minutes after end of test (n=24, 26) 0.88  (1.67) 1.08  (1.47)
Day 32: Resting (n= 25, 27) 0.24  (0.83) 0.48  (0.86)
Day 32: End of Test (n= 25, 28) 2.53  (2.02) 3.07  (2.08)
Day 32: 2 minutes after end of test (n= 25, 26) 0.65  (2.06) 1.06  (1.34)
Week 8: Resting (n= 23, 24) 0.32  (1.02) 0.38  (0.81)
Week 8: End of Test (n= 23, 25) 2.46  (2.02) 2.32  (1.64)
Week 8: 2 minutes after end of test (n= 23, 24) 0.32  (0.92) 0.58  (1.04)
Week 12: Resting (n= 22, 24) 0.05  (0.21) 0.46  (0.97)
Week 12: End of Test (n= 22, 25) 2.27  (1.59) 2.92  (1.95)
Week 12: 2 minutes after end of test (n= 22, 23) 0.35  (0.68) 0.65  (1.06)
Week 16: Resting (n= 19, 23) 0.13  (0.33) 0.50  (1.23)
Week 16: End of Test (n= 18, 23) 2.50  (1.91) 2.83  (1.69)
Week 16: 2 minutes after end of test (n= 19, 23) 0.41  (0.72) 0.70  (1.25)
Week 20: Resting (n= 19, 21) 0.05  (0.16) 0.67  (1.14)
Week 20: End of Test (n= 18,22) 2.31  (1.70) 3.11  (2.17)
Week 20: 2 minutes after end of test (n= 18, 20) 0.31  (0.55) 0.75  (1.15)
Week 24: Resting (n= 20, 21) 0.18  (0.49) 0.40  (0.82)
Week 24: End of Test (n= 20, 21) 2.58  (1.87) 2.93  (1.90)
Week 24: 2 minutes after end of test (n= 20, 20) 0.29  (0.62) 0.67  (1.07)
12.Secondary Outcome
Title Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Hide Description 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)
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The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline breathing ambient air (n=27,28) 61.7  (15.6) 59.2  (11.6)
Baseline every 2 mins breathing NO (1st) (n=20,20) 61.6  (18.7) 55.7  (12.0)
Baseline every 2 mins breathing NO (2nd) (n=17,18) 58.1  (16.7) 53.3  (11.5)
Baseline 5 mins after NO administration (n=20,14) 60.9  (16.2) 56.9  (10.8)
Baseline 15 mins after NO administration(n=19,19) 60.3  (16.0) 56.5  (10.3)
Week 24 breathing ambient air (n=20,22) 52.5  (11.4) 55.5  (11.6)
Week 24 every 2 mins breathing NO (1st) (n=10,13) 50.9  (17.5) 55.1  (13.9)
Week 24 every 2 mins breathing NO (2nd) (n=9,11) 46.2  (18.1) 53.9  (14.1)
Week 24 5 mins after NO administration (n=10,12) 47.0  (15.8) 57.5  (12.8)
Week 24 15 mins after NO administration (n=10,14) 48.1  (13.7) 57.2  (12.4)
13.Secondary Outcome
Title Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Hide Description 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)
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The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline breathing ambient air (n=26,28) 9.0  (2.6) 7.6  (2.3)
Baseline every 2 mins breathing NO (1st) (n=20,17) 9.5  (2.0) 7.7  (2.9)
Baseline every 2 mins breathing NO (2nd) (n=17,16) 9.4  (2.2) 7.8  (3.4)
Baseline 5 mins after NO administration (n=19,12) 9.5  (2.7) 7.8  (2.9)
Baseline 15 mins after NO administration(n=18,17) 9.6  (2.4) 8.1  (2.6)
Week 24 breathing ambient air (n=19,22) 8.4  (3.2) 8.6  (2.8)
Week 24 every 2 mins breathing NO (1st) (n=9,13) 7.9  (3.1) 10.2  (3.7)
Week 24 every 2 mins breathing NO (2nd) (n=9,11) 7.0  (3.4) 10.0  (3.7)
Week 24 5 mins after NO administration (n=10,12) 7.1  (3.1) 10.3  (3.3)
Week 24 15 mins after NO administration (n=10,14) 6.7  (2.8) 10.4  (3.6)
14.Secondary Outcome
Title Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Hide Description 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)
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The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline breathing ambient air (n=26,28) 110.3  (19.5) 108.2  (15.4)
Baseline every 2 mins breathing NO (1st) (n=20,19) 108.3  (18.9) 106.9  (18.0)
Baseline every 2 mins breathing NO (2nd) (n=17,17) 109.9  (19.1) 105.4  (18.1)
Baseline 5 mins after NO administration (n=21,15) 106.0  (17.7) 107.1  (18.6)
Baseline 15 mins after NO administration(n=19,19) 109.5  (20.3) 106.9  (16.7)
Week 24 breathing ambient air (n=20,22) 108.0  (19.8) 106.9  (18.8)
Week 24 every 2 mins breathing NO (1st) (n=10,13) 103.9  (17.5) 102.9  (20.4)
Week 24 every 2 mins breathing NO (2nd) (n=9,11) 104.8  (18.3) 103.6  (19.2)
Week 24 5 mins after NO administration (n=9,12) 103.4  (18.7) 104.0  (20.0)
Week 24 15 mins after NO administration (n=10,14) 103.8  (21.4) 107.3  (18.3)
15.Secondary Outcome
Title Mean Heart Rate (HR) at Baseline and Study Completion
Hide Description 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)
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Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Baseline breathing ambient air (n=27,28) 77.3  (7.5) 84.9  (13.0)
Baseline every 2 mins breathing NO (1st) (n=20,19) 75.9  (12.9) 84.4  (15.5)
Baseline every 2 mins breathing NO (2nd) (n=17,17) 75.2  (13.6) 83.3  (13.2)
Baseline 5 mins after NO administration (n=19,15) 73.2  (10.2) 84.3  (13.9)
Baseline 15 mins after NO administration(n=18,19) 76.2  (9.0) 85.1  (13.8)
Week 24 breathing ambient air (n=20,22) 76.6  (8.6) 83.0  (12.8)
Week 24 every 2 mins breathing NO (1st) (n=9,13) 76.3  (10.1) 82.5  (15.3)
Week 24 every 2 mins breathing NO (2nd) (n=8,11) 76.6  (10.3) 82.8  (16.7)
Week 24 5 mins after NO administration (n=9,12) 75.7  (10.2) 79.3  (10.4)
Week 24 15 mins after NO administration (n=10,14) 73.2  (8.3) 82.9  (10.5)
16.Secondary Outcome
Title Mean Cardiac Output (CO) at Baseline and Study Completion
Hide Description 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)
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Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: L/min
Baseline breathing ambient air (n=27,28) 4.20  (1.33) 4.09  (1.44)
Baseline every 2 mins breathing NO (1st) (n=19,20) 4.02  (1.32) 4.22  (1.64)
Baseline every 2 mins breathing NO (2nd) (n=17,18) 3.98  (1.16) 4.43  (1.80)
Baseline 5 mins after NO administration (n=19,14) 4.20  (1.16) 4.71  (1.95)
Baseline 15 mins after NO administration(n=18,19) 3.87  (1.03) 4.47  (2.15)
Week 24 breathing ambient air (n=20,22) 4.90  (1.21) 4.35  (1.57)
Week 24 every 2 mins breathing NO (1st) (n=10,13) 4.80  (1.26) 4.67  (2.27)
Week 24 every 2 mins breathing NO (2nd) (n=9,11) 4.79  (1.31) 4.62  (2.26)
Week 24 5 mins after NO administration (n=10,12) 4.63  (1.21) 4.65  (1.99)
Week 24 15 mins after NO administration (n=10,14) 4.48  (1.21) 4.46  (1.98)
17.Secondary Outcome
Title Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Hide Description 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)
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The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: dyn*s/cm^5
Baseline breathing ambient air (n=27,27) 1124.4  (460.0) 1118.3  (486.7)
Baseline every 2 mins breathing NO (1st) (n=19,17) 1180.9  (520.8) 1067.9  (509.1)
Baseline every 2 mins breathing NO (2nd) (n=17,16) 1064.6  (458.9) 982.8  (483.9)
Baseline 5 mins after NO administration (n=19,11) 1131.5  (491.2) 1160.4  (510.0)
Baseline 15 mins after NO administration(n=18,16) 1181.9  (498.7) 1132.9  (461.0)
Week 24 breathing ambient air (n=19,21) 729.9  (230.1) 1017.0  (369.1)
Week 24 every 2 mins breathing NO (1st) (n=9,14) 706.9  (285.5) 1000.6  (501.5)
Week 24 every 2 mins breathing NO (2nd) (n=9,11) 687.4  (276.3) 1033.6  (546.2)
Week 24 5 mins after NO administration (n=10,12) 717.2  (271.6) 987.8  (370.4)
Week 24 15 mins after NO administration (n=10,14) 776.1  (286.8) 1042.5  (388.4)
18.Secondary Outcome
Title Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Hide Description 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)
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The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: dyn*s/cm^5
Baseline breathing ambient air (n=26,26) 1674.4  (761.2) 1764.8  (481.9)
Baseline every 2 mins breathing NO (1st) (n=18,15) 1778.2  (709.5) 1769.7  (457.0)
Baseline every 2 mins breathing NO (2nd) (n=16,14) 1807.3  (615.1) 1664.7  (472.0)
Baseline 5 mins after NO administration (n=18,11) 1609.2  (593.4) 1666.6  (488.6)
Baseline 15 mins after NO administration(n=17,15) 1976.3  (877.5) 1748.4  (499.3)
Week 24 breathing ambient air (n=18,21) 1427.2  (446.8) 1667.9  (357.8)
Week 24 every 2 mins breathing NO (1st) (n=9,13) 1344.2  (474.8) 1579.3  (386.8)
Week 24 every 2 mins breathing NO (2nd) (n=9,11) 1367.9  (601.7) 1592.5  (389.0)
Week 24 5 mins after NO administration (n=9,12) 1419.7  (566.6) 1503.9  (305.3)
Week 24 15 mins after NO administration (n=10,14) 1431.7  (524.4) 1629.3  (355.6)
19.Secondary Outcome
Title Blood Gas Measurement - PaO2 at Baseline and Study Completion
Hide Description 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)
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The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline n=22,21 63.36  (14.33) 63.75  (12.02)
Week 24 n=16,17 72.49  (14.09) 70.13  (16.72)
20.Secondary Outcome
Title Blood Gas Measurement - PaCO2 at Baseline and Study Completion
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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STI571
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline n=23,21 32.70  (4.40) 30.02  (4.76)
Week 24 n=16,17 33.36  (5.11) 30.23  (3.55)
21.Secondary Outcome
Title Blood Gas Measurement - PvO2 at Baseline and Study Completion
Hide Description 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)
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Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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STI571
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline n=14,14 33.16  (4.62) 34.70  (4.75)
Week 24 n=11,11 35.56  (3.80) 32.65  (4.18)
22.Secondary Outcome
Title Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: percentage of saturation
Baseline n=19,16 87.99  (9.19) 91.81  (4.05)
Week 24 n=14,15 92.89  (4.50) 91.78  (3.36)
23.Secondary Outcome
Title Blood Gas Measurement - Venous Saturation at Baseline and Study Completion
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: percentage of saturation
Baseline n=17,14 57.96  (10.48) 60.84  (6.61)
Week 24 n=13,13 65.11  (6.91) 57.00  (9.18)
24.Secondary Outcome
Title Blood Gas Measurement - pH at Baseline and Study Completion
Hide Description 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)
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The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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Overall Number of Participants Analyzed 28 31
Mean (Standard Deviation)
Unit of Measure: pH scale
Baseline n=24,23 7.43  (0.04) 7.44  (0.05)
Week 24 n=17,17 7.44  (0.05) 7.46  (0.05)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
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All-Cause Mortality
Core - STI571 Core - Placebo Extension - STI571
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Core - STI571 Core - Placebo Extension - STI571
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/28 (42.86%)   11/31 (35.48%)   16/22 (72.73%) 
Blood and lymphatic system disorders       
Anaemia  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Cardiac disorders       
Aortic valve stenosis  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Atrial flutter  1  0/28 (0.00%)  1/31 (3.23%)  1/22 (4.55%) 
Atrial tachycardia  1  0/28 (0.00%)  1/31 (3.23%)  0/22 (0.00%) 
Cardiac arrest  1  2/28 (7.14%)  2/31 (6.45%)  0/22 (0.00%) 
Cardiac failure  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Cardiac tamponade  1  0/28 (0.00%)  1/31 (3.23%)  0/22 (0.00%) 
Right ventricular failure  1  1/28 (3.57%)  2/31 (6.45%)  1/22 (4.55%) 
Ear and labyrinth disorders       
Tinnitus  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Vertigo  1  1/28 (3.57%)  0/31 (0.00%)  0/22 (0.00%) 
Gastrointestinal disorders       
Anal haemorrhage  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Pancreatitis  1  1/28 (3.57%)  0/31 (0.00%)  0/22 (0.00%) 
Rectal polyp  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
General disorders       
Catheter related complication  1  1/28 (3.57%)  0/31 (0.00%)  0/22 (0.00%) 
Disease progression  1  0/28 (0.00%)  0/31 (0.00%)  7/22 (31.82%) 
General physical health deterioration  1  0/28 (0.00%)  1/31 (3.23%)  0/22 (0.00%) 
Oedema peripheral  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Pyrexia  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Immune system disorders       
Hypersensitivity  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Infections and infestations       
Diverticulitis  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Lung infection  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Urinary tract infection  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Injury, poisoning and procedural complications       
Femur fracture  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Subdural haematoma  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Investigations       
Blood creatinine increased  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Liver function test abnormal  1  1/28 (3.57%)  0/31 (0.00%)  0/22 (0.00%) 
Metabolism and nutrition disorders       
Fluid retention  1  0/28 (0.00%)  2/31 (6.45%)  1/22 (4.55%) 
Hyponatraemia  1  0/28 (0.00%)  1/31 (3.23%)  1/22 (4.55%) 
Nervous system disorders       
Dizziness  1  1/28 (3.57%)  1/31 (3.23%)  0/22 (0.00%) 
Presyncope  1  2/28 (7.14%)  1/31 (3.23%)  1/22 (4.55%) 
Syncope  1  2/28 (7.14%)  1/31 (3.23%)  3/22 (13.64%) 
Renal and urinary disorders       
Renal failure acute  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/28 (0.00%)  2/31 (6.45%)  1/22 (4.55%) 
Dyspnoea at rest  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Haemoptysis  1  1/28 (3.57%)  0/31 (0.00%)  0/22 (0.00%) 
Pulmonary arterial hypertension  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Pulmonary artery aneurysm  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Pulmonary hypertension  1  2/28 (7.14%)  3/31 (9.68%)  1/22 (4.55%) 
Surgical and medical procedures       
Tonsillectomy  1  0/28 (0.00%)  0/31 (0.00%)  1/22 (4.55%) 
Vascular disorders       
Arterial rupture  1  1/28 (3.57%)  0/31 (0.00%)  0/22 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Core - STI571 Core - Placebo Extension - STI571
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/28 (92.86%)   25/31 (80.65%)   21/22 (95.45%) 
Blood and lymphatic system disorders       
Anaemia  1  0/28 (0.00%)  0/31 (0.00%)  3/22 (13.64%) 
Cardiac disorders       
Cardiac failure  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Palpitations  1  3/28 (10.71%)  4/31 (12.90%)  4/22 (18.18%) 
Pericardial effusion  1  0/28 (0.00%)  1/31 (3.23%)  2/22 (9.09%) 
Tachycardia  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Ear and labyrinth disorders       
Tinnitus  1  0/28 (0.00%)  0/31 (0.00%)  3/22 (13.64%) 
Vertigo  1  4/28 (14.29%)  4/31 (12.90%)  8/22 (36.36%) 
Endocrine disorders       
Hypothyroidism  1  0/28 (0.00%)  0/31 (0.00%)  4/22 (18.18%) 
Eye disorders       
Eye swelling  1  3/28 (10.71%)  0/31 (0.00%)  1/22 (4.55%) 
Gastrointestinal disorders       
Abdominal pain  1  4/28 (14.29%)  0/31 (0.00%)  0/22 (0.00%) 
Abdominal pain upper  1  2/28 (7.14%)  1/31 (3.23%)  2/22 (9.09%) 
Ascites  1  0/28 (0.00%)  1/31 (3.23%)  4/22 (18.18%) 
Constipation  1  1/28 (3.57%)  2/31 (6.45%)  2/22 (9.09%) 
Diarrhoea  1  6/28 (21.43%)  3/31 (9.68%)  9/22 (40.91%) 
Dyspepsia  1  3/28 (10.71%)  2/31 (6.45%)  4/22 (18.18%) 
Gastritis  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Gastrooesophageal reflux disease  1  0/28 (0.00%)  3/31 (9.68%)  0/22 (0.00%) 
Nausea  1  14/28 (50.00%)  5/31 (16.13%)  8/22 (36.36%) 
Vomiting  1  6/28 (21.43%)  1/31 (3.23%)  3/22 (13.64%) 
General disorders       
Asthenia  1  0/28 (0.00%)  2/31 (6.45%)  0/22 (0.00%) 
Chest discomfort  1  2/28 (7.14%)  3/31 (9.68%)  4/22 (18.18%) 
Chest pain  1  1/28 (3.57%)  3/31 (9.68%)  1/22 (4.55%) 
Exercise tolerance decreased  1  1/28 (3.57%)  2/31 (6.45%)  0/22 (0.00%) 
Fatigue  1  3/28 (10.71%)  4/31 (12.90%)  3/22 (13.64%) 
General physical health deterioration  1  1/28 (3.57%)  0/31 (0.00%)  3/22 (13.64%) 
Oedema  1  1/28 (3.57%)  0/31 (0.00%)  8/22 (36.36%) 
Oedema peripheral  1  7/28 (25.00%)  5/31 (16.13%)  9/22 (40.91%) 
Pain  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Pyrexia  1  2/28 (7.14%)  0/31 (0.00%)  4/22 (18.18%) 
Infections and infestations       
Bacteriuria  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Bronchitis  1  0/28 (0.00%)  1/31 (3.23%)  2/22 (9.09%) 
Cystitis  1  0/28 (0.00%)  1/31 (3.23%)  2/22 (9.09%) 
Gastrointestinal infection  1  0/28 (0.00%)  1/31 (3.23%)  5/22 (22.73%) 
Helicobacter infection  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Herpes simplex  1  2/28 (7.14%)  1/31 (3.23%)  0/22 (0.00%) 
Nasopharyngitis  1  6/28 (21.43%)  8/31 (25.81%)  14/22 (63.64%) 
Oral candidiasis  1  2/28 (7.14%)  0/31 (0.00%)  0/22 (0.00%) 
Respiratory tract infection  1  6/28 (21.43%)  1/31 (3.23%)  11/22 (50.00%) 
Sinusitis  1  1/28 (3.57%)  0/31 (0.00%)  2/22 (9.09%) 
Urinary tract infection  1  0/28 (0.00%)  0/31 (0.00%)  7/22 (31.82%) 
Injury, poisoning and procedural complications       
Contusion  1  0/28 (0.00%)  2/31 (6.45%)  0/22 (0.00%) 
Investigations       
Blood amylase increased  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Blood creatine phosphokinase increased  1  0/28 (0.00%)  1/31 (3.23%)  3/22 (13.64%) 
Blood creatinine increased  1  1/28 (3.57%)  0/31 (0.00%)  3/22 (13.64%) 
Blood potassium decreased  1  3/28 (10.71%)  0/31 (0.00%)  6/22 (27.27%) 
Blood thyroid stimulating hormone increased  1  0/28 (0.00%)  1/31 (3.23%)  2/22 (9.09%) 
Brain natriuretic peptide increased  1  0/28 (0.00%)  0/31 (0.00%)  3/22 (13.64%) 
C-reactive protein increased  1  0/28 (0.00%)  1/31 (3.23%)  3/22 (13.64%) 
Haemoglobin decreased  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Lipase increased  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Platelet count decreased  1  2/28 (7.14%)  0/31 (0.00%)  1/22 (4.55%) 
Weight decreased  1  1/28 (3.57%)  0/31 (0.00%)  4/22 (18.18%) 
Metabolism and nutrition disorders       
Anorexia  1  2/28 (7.14%)  0/31 (0.00%)  0/22 (0.00%) 
Hyperuricaemia  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Hypokalaemia  1  1/28 (3.57%)  2/31 (6.45%)  4/22 (18.18%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  5/28 (17.86%)  0/31 (0.00%)  3/22 (13.64%) 
Back pain  1  4/28 (14.29%)  4/31 (12.90%)  2/22 (9.09%) 
Muscle spasms  1  4/28 (14.29%)  0/31 (0.00%)  3/22 (13.64%) 
Musculoskeletal pain  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Myalgia  1  0/28 (0.00%)  1/31 (3.23%)  5/22 (22.73%) 
Pain in extremity  1  3/28 (10.71%)  3/31 (9.68%)  1/22 (4.55%) 
Nervous system disorders       
Dizziness  1  3/28 (10.71%)  3/31 (9.68%)  5/22 (22.73%) 
Headache  1  10/28 (35.71%)  6/31 (19.35%)  4/22 (18.18%) 
Psychiatric disorders       
Anxiety  1  1/28 (3.57%)  0/31 (0.00%)  2/22 (9.09%) 
Insomnia  1  1/28 (3.57%)  0/31 (0.00%)  4/22 (18.18%) 
Sleep disorder  1  2/28 (7.14%)  0/31 (0.00%)  4/22 (18.18%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/28 (7.14%)  6/31 (19.35%)  7/22 (31.82%) 
Dyspnoea  1  2/28 (7.14%)  5/31 (16.13%)  3/22 (13.64%) 
Nasal congestion  1  2/28 (7.14%)  0/31 (0.00%)  2/22 (9.09%) 
Oropharyngeal pain  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Rhinitis allergic  1  0/28 (0.00%)  0/31 (0.00%)  3/22 (13.64%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Dry skin  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Periorbital oedema  1  3/28 (10.71%)  0/31 (0.00%)  0/22 (0.00%) 
Pruritus  1  5/28 (17.86%)  3/31 (9.68%)  0/22 (0.00%) 
Rash  1  3/28 (10.71%)  0/31 (0.00%)  3/22 (13.64%) 
Swelling face  1  2/28 (7.14%)  0/31 (0.00%)  2/22 (9.09%) 
Vascular disorders       
Flushing  1  2/28 (7.14%)  3/31 (9.68%)  0/22 (0.00%) 
Haematoma  1  1/28 (3.57%)  0/31 (0.00%)  2/22 (9.09%) 
Hypotension  1  0/28 (0.00%)  0/31 (0.00%)  2/22 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00477269     History of Changes
Other Study ID Numbers: CSTI571E2203
2005-005569-12
First Submitted: May 22, 2007
First Posted: May 23, 2007
Results First Submitted: January 26, 2015
Results First Posted: March 23, 2015
Last Update Posted: March 23, 2015