Trial Outcomes & Findings for Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension (NCT NCT00477269)
NCT ID: NCT00477269
Last Updated: 2015-03-23
Results Overview
In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
59 participants
Primary outcome timeframe
6 months
Results posted on
2015-03-23
Participant Flow
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.
Participant milestones
| Measure |
STI571
STI571
|
Placebo
Placebo
|
All Patients
Open label extension
|
|---|---|---|---|
|
Core Study
STARTED
|
28
|
31
|
0
|
|
Core Study
COMPLETED
|
19
|
23
|
0
|
|
Core Study
NOT COMPLETED
|
9
|
8
|
0
|
|
Open Label Extension
STARTED
|
0
|
0
|
22
|
|
Open Label Extension
COMPLETED
|
0
|
0
|
9
|
|
Open Label Extension
NOT COMPLETED
|
0
|
0
|
13
|
Reasons for withdrawal
| Measure |
STI571
STI571
|
Placebo
Placebo
|
All Patients
Open label extension
|
|---|---|---|---|
|
Core Study
Adverse Event
|
6
|
4
|
0
|
|
Core Study
Death
|
3
|
3
|
0
|
|
Core Study
Withdrawn Consent
|
0
|
1
|
0
|
|
Open Label Extension
Adverse Event
|
0
|
0
|
4
|
|
Open Label Extension
Abnormal laboratory values
|
0
|
0
|
1
|
|
Open Label Extension
unsatisfactory therapeutic effects
|
0
|
0
|
2
|
|
Open Label Extension
Adminiatrative problems
|
0
|
0
|
2
|
|
Open Label Extension
Death
|
0
|
0
|
4
|
Baseline Characteristics
Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 15.7 • n=7 Participants
|
44.3 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Safety Population all participants enrolled was included in this population
In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core
SAE(s)
|
12 participants
|
11 participants
|
|
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core
Paients with AE(s)
|
27 participants
|
29 participants
|
|
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core
Death
|
3 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 72 monthsPopulation: 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.
In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.
Outcome measures
| Measure |
STI571
n=22 Participants
STI571
|
Placebo
Placebo
|
|---|---|---|
|
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension
Any AE(s)
|
22 participants
|
—
|
|
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension
Death
|
4 participants
|
—
|
|
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension
SAE(s)
|
16 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods
Day 32 (n=25,27)
|
10.2 meters
Standard Deviation 53.7
|
8.2 meters
Standard Deviation 27.5
|
|
Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods
week 8 (n=23,24)
|
17.0 meters
Standard Deviation 55.6
|
15.5 meters
Standard Deviation 40.8
|
|
Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods
week 12 (n=22,24)
|
21 meters
Standard Deviation 36.2
|
7.8 meters
Standard Deviation 50.0
|
|
Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods
week 16 (n=19, 23)
|
25.5 meters
Standard Deviation 43.1
|
12.1 meters
Standard Deviation 47.9
|
|
Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods
week 20 (n=19, 21)
|
38.3 meters
Standard Deviation 42.5
|
12.8 meters
Standard Deviation 60.4
|
|
Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods
study completion Week 24 (n=21, 12)
|
22.0 meters
Standard Deviation 63.1
|
-1.0 meters
Standard Deviation 53.3
|
PRIMARY outcome
Timeframe: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods
Day 32 (n=25,27)
|
-0.2 number of stops
Standard Deviation 0.7
|
0.1 number of stops
Standard Deviation 0.4
|
|
Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods
week 8 (n=23,24)
|
-0.2 number of stops
Standard Deviation 0.7
|
0.0 number of stops
Standard Deviation 1.1
|
|
Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods
week 12 (n=22,24)
|
-0.3 number of stops
Standard Deviation 0.9
|
0.3 number of stops
Standard Deviation 0.9
|
|
Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods
week 16 (n=19, 23)
|
-0.3 number of stops
Standard Deviation 0.8
|
0.0 number of stops
Standard Deviation 0.2
|
|
Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods
week 20 (n=19, 21)
|
-0.4 number of stops
Standard Deviation 1.0
|
0.3 number of stops
Standard Deviation 1.0
|
|
Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods
study completion Week 24 (n=21, 12)
|
-0.3 number of stops
Standard Deviation 0.8
|
-0.1 number of stops
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods
Day 32 (n=25,27)
|
-0.06 minutes
Standard Deviation 0.19
|
0.12 minutes
Standard Deviation 0.36
|
|
Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods
week 8 (n=23,24)
|
-0.03 minutes
Standard Deviation 0.10
|
0.07 minutes
Standard Deviation 0.27
|
|
Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods
week 12 (n=22,24)
|
-0.03 minutes
Standard Deviation 0.10
|
0.19 minutes
Standard Deviation 0.55
|
|
Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods
week 16 (n=19, 23)
|
-0.03 minutes
Standard Deviation 0.10
|
0.06 minutes
Standard Deviation 0.26
|
|
Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods
week 20 (n=19, 21)
|
-0.05 minutes
Standard Deviation 0.15
|
0.12 minutes
Standard Deviation 0.42
|
|
Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods
study completion Week 24 (n=21, 12)
|
-0.02 minutes
Standard Deviation 0.10
|
0.03 minutes
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completionPopulation: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Baseline: WHO Class IV (n=27,30)
|
2 number of participants
|
1 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Baseline: WHO Class III (n=27,30)
|
14 number of participants
|
22 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Baseline: WHO Class II (n=27,30)
|
11 number of participants
|
7 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Day 32: WHO Class IV (n=27,30)
|
3 number of participants
|
3 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Day 32: WHO Class III (n=27,30)
|
11 number of participants
|
21 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Day 32: WHO Class II (n=27,30)
|
13 number of participants
|
6 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 8: WHO Class IV (n=24,27)
|
3 number of participants
|
1 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 8: WHO Class III (n=24,27)
|
9 number of participants
|
20 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 8: WHO Class II (n=24,27)
|
12 number of participants
|
6 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 12: WHO Class IV (n=23,27)
|
0 number of participants
|
1 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 12: WHO Class III (n=23,27)
|
12 number of participants
|
17 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 12: WHO Class II (n=23,27)
|
11 number of participants
|
9 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 16: WHO Class IV (n=22,27)
|
0 number of participants
|
1 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 16: WHO Class III (n=22,27)
|
11 number of participants
|
18 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 16: WHO Class II (n=22,27)
|
11 number of participants
|
7 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 16: WHO Class I (n=22,27)
|
0 number of participants
|
1 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 20: WHO Class IV (n=19,24)
|
0 number of participants
|
1 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 20: WHO Class III (n=19,24)
|
10 number of participants
|
14 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 20: WHO Class II (n=19,24)
|
8 number of participants
|
9 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 20: WHO Class I (n=19,24)
|
1 number of participants
|
0 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 24: WHO Class IV (n=21,25)
|
1 number of participants
|
2 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 24: WHO Class III (n=21,25)
|
12 number of participants
|
13 number of participants
|
|
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity
Week 24: WHO Class II (n=21,25)
|
8 number of participants
|
10 number of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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%.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Baseline: Resting (n= 28, 29)
|
94.3 Percentage of Oxygen Saturation
Standard Deviation 4.6
|
93.4 Percentage of Oxygen Saturation
Standard Deviation 4.7
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Baseline: End of Test (n= 28, 28)
|
87.9 Percentage of Oxygen Saturation
Standard Deviation 12.4
|
87.9 Percentage of Oxygen Saturation
Standard Deviation 8.2
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Baseline: 2 minutes after end of test (n=26, 26)
|
93.0 Percentage of Oxygen Saturation
Standard Deviation 7.0
|
92.0 Percentage of Oxygen Saturation
Standard Deviation 6.2
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Day 32: Resting (n= 25, 28)
|
94.5 Percentage of Oxygen Saturation
Standard Deviation 4.0
|
92.4 Percentage of Oxygen Saturation
Standard Deviation 6.3
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Day 32: End of Test (n= 25, 28)
|
89.0 Percentage of Oxygen Saturation
Standard Deviation 11.2
|
87.2 Percentage of Oxygen Saturation
Standard Deviation 12.8
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Day 32: 2 minutes after end of test (n= 25, 26)
|
94.8 Percentage of Oxygen Saturation
Standard Deviation 4.6
|
92.7 Percentage of Oxygen Saturation
Standard Deviation 7.1
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 8: Resting (n= 23, 25)
|
95.1 Percentage of Oxygen Saturation
Standard Deviation 3.3
|
93.2 Percentage of Oxygen Saturation
Standard Deviation 6.1
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 8: End of Test (n= 23, 24)
|
90.9 Percentage of Oxygen Saturation
Standard Deviation 6.7
|
87.9 Percentage of Oxygen Saturation
Standard Deviation 11.9
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 8: 2 minutes after end of test (n= 23, 23)
|
94.4 Percentage of Oxygen Saturation
Standard Deviation 5.3
|
93.1 Percentage of Oxygen Saturation
Standard Deviation 7.8
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 12: Resting (n= 22, 25)
|
95.1 Percentage of Oxygen Saturation
Standard Deviation 4.8
|
93.9 Percentage of Oxygen Saturation
Standard Deviation 5.6
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 12: End of Test (n= 20, 24)
|
89.8 Percentage of Oxygen Saturation
Standard Deviation 9.2
|
89.6 Percentage of Oxygen Saturation
Standard Deviation 8.9
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 12: 2 minutes after end of test (n= 19, 22)
|
92.7 Percentage of Oxygen Saturation
Standard Deviation 8.9
|
94.2 Percentage of Oxygen Saturation
Standard Deviation 5.6
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 16: Resting (n= 19, 24)
|
95.0 Percentage of Oxygen Saturation
Standard Deviation 5.0
|
94.1 Percentage of Oxygen Saturation
Standard Deviation 5.1
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 16: End of Test (n= 18, 23)
|
87.9 Percentage of Oxygen Saturation
Standard Deviation 13.1
|
88.1 Percentage of Oxygen Saturation
Standard Deviation 9.8
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 16: 2 minutes after end of test (n= 19, 19)
|
94.6 Percentage of Oxygen Saturation
Standard Deviation 6.0
|
93.3 Percentage of Oxygen Saturation
Standard Deviation 8.0
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 20: Resting (n= 19, 22)
|
94.0 Percentage of Oxygen Saturation
Standard Deviation 4.7
|
93.7 Percentage of Oxygen Saturation
Standard Deviation 5.0
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 20: End of Test (n= 18, 21)
|
87.5 Percentage of Oxygen Saturation
Standard Deviation 13.2
|
87.6 Percentage of Oxygen Saturation
Standard Deviation 9.1
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 20: 2 minutes after end of test (n= 19, 21)
|
93.8 Percentage of Oxygen Saturation
Standard Deviation 7.1
|
93.4 Percentage of Oxygen Saturation
Standard Deviation 7.4
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 24: Resting (n= 20, 22)
|
95.5 Percentage of Oxygen Saturation
Standard Deviation 3.4
|
94.3 Percentage of Oxygen Saturation
Standard Deviation 4.6
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 24: End of Test (n= 20, 21)
|
89.9 Percentage of Oxygen Saturation
Standard Deviation 7.1
|
89.3 Percentage of Oxygen Saturation
Standard Deviation 8.4
|
|
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods
Week 24: 2 minutes after end of test (n= 20, 21)
|
94.8 Percentage of Oxygen Saturation
Standard Deviation 4.3
|
94.8 Percentage of Oxygen Saturation
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Baseline: Resting (n= 26, 28)
|
111.3 mmHg
Standard Deviation 14.2
|
104.6 mmHg
Standard Deviation 13.2
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Baseline: End of Test (n= 21, 26)
|
119.9 mmHg
Standard Deviation 19.3
|
118.3 mmHg
Standard Deviation 18.0
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Baseline: 2 minutes after end of test (n=25, 27)
|
120.0 mmHg
Standard Deviation 18.3
|
110.4 mmHg
Standard Deviation 13.6
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Day 32: Resting (n= 25, 27)
|
111.4 mmHg
Standard Deviation 9.6
|
106.0 mmHg
Standard Deviation 12.3
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Day 32: End of Test (n= 22, 22)
|
126.5 mmHg
Standard Deviation 17.3
|
122.3 mmHg
Standard Deviation 18.6
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Day 32: 2 minutes after end of test (n= 25, 26)
|
119.6 mmHg
Standard Deviation 12.6
|
113.8 mmHg
Standard Deviation 14.9
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 8: Resting (n= 22, 24)
|
108.9 mmHg
Standard Deviation 12.3
|
107.3 mmHg
Standard Deviation 13.5
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 8: End of Test (n= 19, 20)
|
124.6 mmHg
Standard Deviation 16.1
|
119.9 mmHg
Standard Deviation 17.1
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 8: 2 minutes after end of test (n= 23, 24)
|
115.2 mmHg
Standard Deviation 13.6
|
114.5 mmHg
Standard Deviation 13.7
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 12: Resting (n= 22, 23)
|
106.5 mmHg
Standard Deviation 11.5
|
107.7 mmHg
Standard Deviation 13.8
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 12: End of Test (n= 17, 19)
|
122.2 mmHg
Standard Deviation 17.0
|
118.8 mmHg
Standard Deviation 22.9
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 12: 2 minutes after end of test (n= 20, 22)
|
115.9 mmHg
Standard Deviation 14.2
|
115.9 mmHg
Standard Deviation 14.9
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 16: Resting (n= 19, 22)
|
106.7 mmHg
Standard Deviation 9.7
|
105.7 mmHg
Standard Deviation 12.5
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 16: End of Test (n= 15,18)
|
117.2 mmHg
Standard Deviation 12.3
|
119.8 mmHg
Standard Deviation 13.5
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 16: 2 minutes after end of test (n= 19, 22)
|
114.6 mmHg
Standard Deviation 13.8
|
112.6 mmHg
Standard Deviation 15.8
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 20: Resting (n= 19, 20)
|
106.5 mmHg
Standard Deviation 7.0
|
109.1 mmHg
Standard Deviation 12.1
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 20: End of Test (n= 16,17)
|
122.4 mmHg
Standard Deviation 13.3
|
119.9 mmHg
Standard Deviation 19.3
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 20: 2 minutes after end of test (n= 19, 20)
|
115.5 mmHg
Standard Deviation 14.0
|
115.1 mmHg
Standard Deviation 15.1
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 24: Resting (n= 20, 21)
|
110.6 mmHg
Standard Deviation 15.6
|
108.2 mmHg
Standard Deviation 15.7
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 24: End of Test (n= 16, 17)
|
126.9 mmHg
Standard Deviation 23.6
|
116.8 mmHg
Standard Deviation 14.9
|
|
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 24: 2 minutes after end of test (n= 20, 19)
|
118.2 mmHg
Standard Deviation 18.6
|
111.1 mmHg
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Baseline: Resting (n= 26, 28)
|
68.2 mmHg
Standard Deviation 10.2
|
67.9 mmHg
Standard Deviation 8.9
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Baseline: End of Test (n= 21, 26)
|
75.1 mmHg
Standard Deviation 10.8
|
69.5 mmHg
Standard Deviation 11.9
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Baseline: 2 minutes after end of test (n=25, 27)
|
71.6 mmHg
Standard Deviation 9.8
|
67.9 mmHg
Standard Deviation 9.6
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Day 32: Resting (n= 25, 27)
|
69.6 mmHg
Standard Deviation 10.4
|
68.4 mmHg
Standard Deviation 8.8
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Day 32: End of Test (n= 22, 22)
|
78.2 mmHg
Standard Deviation 12.3
|
75.2 mmHg
Standard Deviation 11.2
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Day 32: 2 minutes after end of test (n= 25, 26)
|
72.5 mmHg
Standard Deviation 9.1
|
70.7 mmHg
Standard Deviation 9.4
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 8: Resting (n= 22, 24)
|
67.7 mmHg
Standard Deviation 11.8
|
68.8 mmHg
Standard Deviation 9.0
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 8: End of Test (n= 19, 20)
|
74.8 mmHg
Standard Deviation 10.8
|
74.0 mmHg
Standard Deviation 10.9
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 8: 2 minutes after end of test (n= 23, 24)
|
71.2 mmHg
Standard Deviation 10.3
|
72.2 mmHg
Standard Deviation 11.7
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 12: Resting (n= 22, 23)
|
65.5 mmHg
Standard Deviation 8.3
|
70.6 mmHg
Standard Deviation 11.6
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 12: End of Test (n= 17, 19)
|
75.6 mmHg
Standard Deviation 11.5
|
72.4 mmHg
Standard Deviation 14.3
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 12: 2 minutes after end of test (n= 20, 22)
|
73.1 mmHg
Standard Deviation 8.9
|
72.0 mmHg
Standard Deviation 13.7
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 16: Resting (n= 19, 22)
|
67.7 mmHg
Standard Deviation 9.9
|
66.7 mmHg
Standard Deviation 7.7
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 16: End of Test (n= 15,18)
|
72.7 mmHg
Standard Deviation 9.2
|
76.7 mmHg
Standard Deviation 8.6
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 16: 2 minutes after end of test (n= 19, 22)
|
71.4 mmHg
Standard Deviation 11.0
|
70.5 mmHg
Standard Deviation 8.0
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 20: Resting (n= 19, 20)
|
67.2 mmHg
Standard Deviation 8.0
|
69.8 mmHg
Standard Deviation 8.8
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 20: End of Test (n= 16,17)
|
72.9 mmHg
Standard Deviation 8.7
|
72.9 mmHg
Standard Deviation 8.1
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 20: 2 minutes after end of test (n= 19, 20)
|
71.9 mmHg
Standard Deviation 9.2
|
72.7 mmHg
Standard Deviation 9.8
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 24: Resting (n= 20, 21)
|
69.7 mmHg
Standard Deviation 10.3
|
70.7 mmHg
Standard Deviation 10.9
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 24: End of Test (n= 16, 17)
|
74.1 mmHg
Standard Deviation 10.7
|
72.3 mmHg
Standard Deviation 10.9
|
|
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods
Week 24: 2 minutes after end of test (n= 20, 19)
|
71.3 mmHg
Standard Deviation 10.1
|
72.9 mmHg
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Baseline: Resting (n= 28, 29)
|
80.8 beats per minute (bpm)
Standard Deviation 13.0
|
87.9 beats per minute (bpm)
Standard Deviation 12.7
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Baseline: End of Test (n= 28, 29)
|
106.3 beats per minute (bpm)
Standard Deviation 23.9
|
112.3 beats per minute (bpm)
Standard Deviation 20.4
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Baseline: 2 minutes after end of test (n=26, 26)
|
84.2 beats per minute (bpm)
Standard Deviation 16.9
|
94.1 beats per minute (bpm)
Standard Deviation 14.6
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Day 32: Resting (n= 25, 28)
|
80.7 beats per minute (bpm)
Standard Deviation 14.3
|
83.6 beats per minute (bpm)
Standard Deviation 15.7
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Day 32: End of Test (n= 25, 28)
|
108.4 beats per minute (bpm)
Standard Deviation 19.1
|
113.1 beats per minute (bpm)
Standard Deviation 19.5
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Day 32: 2 minutes after end of test (n= 25, 26)
|
89.2 beats per minute (bpm)
Standard Deviation 17.0
|
90.6 beats per minute (bpm)
Standard Deviation 14.1
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 8: Resting (n= 23, 25)
|
80.3 beats per minute (bpm)
Standard Deviation 9.6
|
81.1 beats per minute (bpm)
Standard Deviation 11.2
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 8: End of Test (n= 23, 24)
|
109.5 beats per minute (bpm)
Standard Deviation 21.4
|
110.3 beats per minute (bpm)
Standard Deviation 26.4
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 8: 2 minutes after end of test (n= 23, 23)
|
85.3 beats per minute (bpm)
Standard Deviation 15.7
|
88.9 beats per minute (bpm)
Standard Deviation 13.2
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 12: Resting (n= 22, 25)
|
76.5 beats per minute (bpm)
Standard Deviation 13.2
|
85.1 beats per minute (bpm)
Standard Deviation 13.2
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 12: End of Test (n= 20, 25)
|
105.3 beats per minute (bpm)
Standard Deviation 26.2
|
113.0 beats per minute (bpm)
Standard Deviation 26.5
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 12: 2 minutes after end of test (n= 19, 22)
|
83.8 beats per minute (bpm)
Standard Deviation 17.8
|
89.4 beats per minute (bpm)
Standard Deviation 15.7
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 16: Resting (n= 19, 24)
|
76.5 beats per minute (bpm)
Standard Deviation 13.2
|
84.4 beats per minute (bpm)
Standard Deviation 12.9
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 16: End of Test (n= 18, 23)
|
102.8 beats per minute (bpm)
Standard Deviation 25.6
|
117.9 beats per minute (bpm)
Standard Deviation 24.3
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 16: 2 minutes after end of test (n= 19, 21)
|
85.8 beats per minute (bpm)
Standard Deviation 21.0
|
85.5 beats per minute (bpm)
Standard Deviation 14.4
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 20: Resting (n= 19, 22)
|
75.3 beats per minute (bpm)
Standard Deviation 13.8
|
80.2 beats per minute (bpm)
Standard Deviation 9.6
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 20: End of Test (n= 18,22)
|
109.2 beats per minute (bpm)
Standard Deviation 26.8
|
118.0 beats per minute (bpm)
Standard Deviation 24.5
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 20: 2 minutes after end of test (n= 19, 21)
|
83.3 beats per minute (bpm)
Standard Deviation 17.4
|
87.3 beats per minute (bpm)
Standard Deviation 11.4
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 24: Resting (n= 20, 22)
|
79.5 beats per minute (bpm)
Standard Deviation 13.8
|
83.6 beats per minute (bpm)
Standard Deviation 8.6
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 24: End of Test (n= 20, 21)
|
110.2 beats per minute (bpm)
Standard Deviation 18.1
|
116.8 beats per minute (bpm)
Standard Deviation 21.7
|
|
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods
Week 24: 2 minutes after end of test (n= 20, 21)
|
87.9 beats per minute (bpm)
Standard Deviation 17.5
|
88.9 beats per minute (bpm)
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Baseline: Resting (n= 26, 27)
|
0.27 score on a scale
Standard Deviation 0.83
|
0.43 score on a scale
Standard Deviation 0.92
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Baseline: End of Test (n= 27, 29)
|
3.34 score on a scale
Standard Deviation 2.30
|
3.02 score on a scale
Standard Deviation 1.59
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Baseline: 2 minutes after end of test (n=24, 26)
|
0.88 score on a scale
Standard Deviation 1.67
|
1.08 score on a scale
Standard Deviation 1.47
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Day 32: Resting (n= 25, 27)
|
0.24 score on a scale
Standard Deviation 0.83
|
0.48 score on a scale
Standard Deviation 0.86
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Day 32: End of Test (n= 25, 28)
|
2.53 score on a scale
Standard Deviation 2.02
|
3.07 score on a scale
Standard Deviation 2.08
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Day 32: 2 minutes after end of test (n= 25, 26)
|
0.65 score on a scale
Standard Deviation 2.06
|
1.06 score on a scale
Standard Deviation 1.34
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 8: Resting (n= 23, 24)
|
0.32 score on a scale
Standard Deviation 1.02
|
0.38 score on a scale
Standard Deviation 0.81
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 8: End of Test (n= 23, 25)
|
2.46 score on a scale
Standard Deviation 2.02
|
2.32 score on a scale
Standard Deviation 1.64
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 8: 2 minutes after end of test (n= 23, 24)
|
0.32 score on a scale
Standard Deviation 0.92
|
0.58 score on a scale
Standard Deviation 1.04
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 12: Resting (n= 22, 24)
|
0.05 score on a scale
Standard Deviation 0.21
|
0.46 score on a scale
Standard Deviation 0.97
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 12: End of Test (n= 22, 25)
|
2.27 score on a scale
Standard Deviation 1.59
|
2.92 score on a scale
Standard Deviation 1.95
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 12: 2 minutes after end of test (n= 22, 23)
|
0.35 score on a scale
Standard Deviation 0.68
|
0.65 score on a scale
Standard Deviation 1.06
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 16: Resting (n= 19, 23)
|
0.13 score on a scale
Standard Deviation 0.33
|
0.50 score on a scale
Standard Deviation 1.23
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 16: End of Test (n= 18, 23)
|
2.50 score on a scale
Standard Deviation 1.91
|
2.83 score on a scale
Standard Deviation 1.69
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 16: 2 minutes after end of test (n= 19, 23)
|
0.41 score on a scale
Standard Deviation 0.72
|
0.70 score on a scale
Standard Deviation 1.25
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 20: Resting (n= 19, 21)
|
0.05 score on a scale
Standard Deviation 0.16
|
0.67 score on a scale
Standard Deviation 1.14
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 20: End of Test (n= 18,22)
|
2.31 score on a scale
Standard Deviation 1.70
|
3.11 score on a scale
Standard Deviation 2.17
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 20: 2 minutes after end of test (n= 18, 20)
|
0.31 score on a scale
Standard Deviation 0.55
|
0.75 score on a scale
Standard Deviation 1.15
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 24: Resting (n= 20, 21)
|
0.18 score on a scale
Standard Deviation 0.49
|
0.40 score on a scale
Standard Deviation 0.82
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 24: End of Test (n= 20, 21)
|
2.58 score on a scale
Standard Deviation 1.87
|
2.93 score on a scale
Standard Deviation 1.90
|
|
Borg Score During the Six Minutes Walk Test at Different Time Periods
Week 24: 2 minutes after end of test (n= 20, 20)
|
0.29 score on a scale
Standard Deviation 0.62
|
0.67 score on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Baseline breathing ambient air (n=27,28)
|
61.7 mmHg
Standard Deviation 15.6
|
59.2 mmHg
Standard Deviation 11.6
|
|
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Baseline every 2 mins breathing NO (1st) (n=20,20)
|
61.6 mmHg
Standard Deviation 18.7
|
55.7 mmHg
Standard Deviation 12.0
|
|
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Baseline every 2 mins breathing NO (2nd) (n=17,18)
|
58.1 mmHg
Standard Deviation 16.7
|
53.3 mmHg
Standard Deviation 11.5
|
|
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Baseline 5 mins after NO administration (n=20,14)
|
60.9 mmHg
Standard Deviation 16.2
|
56.9 mmHg
Standard Deviation 10.8
|
|
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Baseline 15 mins after NO administration(n=19,19)
|
60.3 mmHg
Standard Deviation 16.0
|
56.5 mmHg
Standard Deviation 10.3
|
|
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Week 24 breathing ambient air (n=20,22)
|
52.5 mmHg
Standard Deviation 11.4
|
55.5 mmHg
Standard Deviation 11.6
|
|
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (1st) (n=10,13)
|
50.9 mmHg
Standard Deviation 17.5
|
55.1 mmHg
Standard Deviation 13.9
|
|
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (2nd) (n=9,11)
|
46.2 mmHg
Standard Deviation 18.1
|
53.9 mmHg
Standard Deviation 14.1
|
|
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Week 24 5 mins after NO administration (n=10,12)
|
47.0 mmHg
Standard Deviation 15.8
|
57.5 mmHg
Standard Deviation 12.8
|
|
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion
Week 24 15 mins after NO administration (n=10,14)
|
48.1 mmHg
Standard Deviation 13.7
|
57.2 mmHg
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Baseline breathing ambient air (n=26,28)
|
9.0 mmHg
Standard Deviation 2.6
|
7.6 mmHg
Standard Deviation 2.3
|
|
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Baseline every 2 mins breathing NO (1st) (n=20,17)
|
9.5 mmHg
Standard Deviation 2.0
|
7.7 mmHg
Standard Deviation 2.9
|
|
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Baseline every 2 mins breathing NO (2nd) (n=17,16)
|
9.4 mmHg
Standard Deviation 2.2
|
7.8 mmHg
Standard Deviation 3.4
|
|
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Baseline 5 mins after NO administration (n=19,12)
|
9.5 mmHg
Standard Deviation 2.7
|
7.8 mmHg
Standard Deviation 2.9
|
|
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Baseline 15 mins after NO administration(n=18,17)
|
9.6 mmHg
Standard Deviation 2.4
|
8.1 mmHg
Standard Deviation 2.6
|
|
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Week 24 breathing ambient air (n=19,22)
|
8.4 mmHg
Standard Deviation 3.2
|
8.6 mmHg
Standard Deviation 2.8
|
|
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (1st) (n=9,13)
|
7.9 mmHg
Standard Deviation 3.1
|
10.2 mmHg
Standard Deviation 3.7
|
|
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (2nd) (n=9,11)
|
7.0 mmHg
Standard Deviation 3.4
|
10.0 mmHg
Standard Deviation 3.7
|
|
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Week 24 5 mins after NO administration (n=10,12)
|
7.1 mmHg
Standard Deviation 3.1
|
10.3 mmHg
Standard Deviation 3.3
|
|
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion
Week 24 15 mins after NO administration (n=10,14)
|
6.7 mmHg
Standard Deviation 2.8
|
10.4 mmHg
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Baseline breathing ambient air (n=26,28)
|
110.3 mmHg
Standard Deviation 19.5
|
108.2 mmHg
Standard Deviation 15.4
|
|
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Baseline every 2 mins breathing NO (1st) (n=20,19)
|
108.3 mmHg
Standard Deviation 18.9
|
106.9 mmHg
Standard Deviation 18.0
|
|
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Baseline every 2 mins breathing NO (2nd) (n=17,17)
|
109.9 mmHg
Standard Deviation 19.1
|
105.4 mmHg
Standard Deviation 18.1
|
|
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Baseline 5 mins after NO administration (n=21,15)
|
106.0 mmHg
Standard Deviation 17.7
|
107.1 mmHg
Standard Deviation 18.6
|
|
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Baseline 15 mins after NO administration(n=19,19)
|
109.5 mmHg
Standard Deviation 20.3
|
106.9 mmHg
Standard Deviation 16.7
|
|
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Week 24 breathing ambient air (n=20,22)
|
108.0 mmHg
Standard Deviation 19.8
|
106.9 mmHg
Standard Deviation 18.8
|
|
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (1st) (n=10,13)
|
103.9 mmHg
Standard Deviation 17.5
|
102.9 mmHg
Standard Deviation 20.4
|
|
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (2nd) (n=9,11)
|
104.8 mmHg
Standard Deviation 18.3
|
103.6 mmHg
Standard Deviation 19.2
|
|
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Week 24 5 mins after NO administration (n=9,12)
|
103.4 mmHg
Standard Deviation 18.7
|
104.0 mmHg
Standard Deviation 20.0
|
|
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion
Week 24 15 mins after NO administration (n=10,14)
|
103.8 mmHg
Standard Deviation 21.4
|
107.3 mmHg
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Mean Heart Rate (HR) at Baseline and Study Completion
Baseline breathing ambient air (n=27,28)
|
77.3 beats per minute (bpm)
Standard Deviation 7.5
|
84.9 beats per minute (bpm)
Standard Deviation 13.0
|
|
Mean Heart Rate (HR) at Baseline and Study Completion
Baseline every 2 mins breathing NO (1st) (n=20,19)
|
75.9 beats per minute (bpm)
Standard Deviation 12.9
|
84.4 beats per minute (bpm)
Standard Deviation 15.5
|
|
Mean Heart Rate (HR) at Baseline and Study Completion
Baseline every 2 mins breathing NO (2nd) (n=17,17)
|
75.2 beats per minute (bpm)
Standard Deviation 13.6
|
83.3 beats per minute (bpm)
Standard Deviation 13.2
|
|
Mean Heart Rate (HR) at Baseline and Study Completion
Baseline 5 mins after NO administration (n=19,15)
|
73.2 beats per minute (bpm)
Standard Deviation 10.2
|
84.3 beats per minute (bpm)
Standard Deviation 13.9
|
|
Mean Heart Rate (HR) at Baseline and Study Completion
Baseline 15 mins after NO administration(n=18,19)
|
76.2 beats per minute (bpm)
Standard Deviation 9.0
|
85.1 beats per minute (bpm)
Standard Deviation 13.8
|
|
Mean Heart Rate (HR) at Baseline and Study Completion
Week 24 breathing ambient air (n=20,22)
|
76.6 beats per minute (bpm)
Standard Deviation 8.6
|
83.0 beats per minute (bpm)
Standard Deviation 12.8
|
|
Mean Heart Rate (HR) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (1st) (n=9,13)
|
76.3 beats per minute (bpm)
Standard Deviation 10.1
|
82.5 beats per minute (bpm)
Standard Deviation 15.3
|
|
Mean Heart Rate (HR) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (2nd) (n=8,11)
|
76.6 beats per minute (bpm)
Standard Deviation 10.3
|
82.8 beats per minute (bpm)
Standard Deviation 16.7
|
|
Mean Heart Rate (HR) at Baseline and Study Completion
Week 24 5 mins after NO administration (n=9,12)
|
75.7 beats per minute (bpm)
Standard Deviation 10.2
|
79.3 beats per minute (bpm)
Standard Deviation 10.4
|
|
Mean Heart Rate (HR) at Baseline and Study Completion
Week 24 15 mins after NO administration (n=10,14)
|
73.2 beats per minute (bpm)
Standard Deviation 8.3
|
82.9 beats per minute (bpm)
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Mean Cardiac Output (CO) at Baseline and Study Completion
Baseline breathing ambient air (n=27,28)
|
4.20 L/min
Standard Deviation 1.33
|
4.09 L/min
Standard Deviation 1.44
|
|
Mean Cardiac Output (CO) at Baseline and Study Completion
Baseline every 2 mins breathing NO (1st) (n=19,20)
|
4.02 L/min
Standard Deviation 1.32
|
4.22 L/min
Standard Deviation 1.64
|
|
Mean Cardiac Output (CO) at Baseline and Study Completion
Baseline every 2 mins breathing NO (2nd) (n=17,18)
|
3.98 L/min
Standard Deviation 1.16
|
4.43 L/min
Standard Deviation 1.80
|
|
Mean Cardiac Output (CO) at Baseline and Study Completion
Baseline 5 mins after NO administration (n=19,14)
|
4.20 L/min
Standard Deviation 1.16
|
4.71 L/min
Standard Deviation 1.95
|
|
Mean Cardiac Output (CO) at Baseline and Study Completion
Baseline 15 mins after NO administration(n=18,19)
|
3.87 L/min
Standard Deviation 1.03
|
4.47 L/min
Standard Deviation 2.15
|
|
Mean Cardiac Output (CO) at Baseline and Study Completion
Week 24 breathing ambient air (n=20,22)
|
4.90 L/min
Standard Deviation 1.21
|
4.35 L/min
Standard Deviation 1.57
|
|
Mean Cardiac Output (CO) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (1st) (n=10,13)
|
4.80 L/min
Standard Deviation 1.26
|
4.67 L/min
Standard Deviation 2.27
|
|
Mean Cardiac Output (CO) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (2nd) (n=9,11)
|
4.79 L/min
Standard Deviation 1.31
|
4.62 L/min
Standard Deviation 2.26
|
|
Mean Cardiac Output (CO) at Baseline and Study Completion
Week 24 5 mins after NO administration (n=10,12)
|
4.63 L/min
Standard Deviation 1.21
|
4.65 L/min
Standard Deviation 1.99
|
|
Mean Cardiac Output (CO) at Baseline and Study Completion
Week 24 15 mins after NO administration (n=10,14)
|
4.48 L/min
Standard Deviation 1.21
|
4.46 L/min
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Baseline breathing ambient air (n=27,27)
|
1124.4 dyn*s/cm^5
Standard Deviation 460.0
|
1118.3 dyn*s/cm^5
Standard Deviation 486.7
|
|
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Baseline every 2 mins breathing NO (1st) (n=19,17)
|
1180.9 dyn*s/cm^5
Standard Deviation 520.8
|
1067.9 dyn*s/cm^5
Standard Deviation 509.1
|
|
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Baseline every 2 mins breathing NO (2nd) (n=17,16)
|
1064.6 dyn*s/cm^5
Standard Deviation 458.9
|
982.8 dyn*s/cm^5
Standard Deviation 483.9
|
|
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Baseline 5 mins after NO administration (n=19,11)
|
1131.5 dyn*s/cm^5
Standard Deviation 491.2
|
1160.4 dyn*s/cm^5
Standard Deviation 510.0
|
|
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Baseline 15 mins after NO administration(n=18,16)
|
1181.9 dyn*s/cm^5
Standard Deviation 498.7
|
1132.9 dyn*s/cm^5
Standard Deviation 461.0
|
|
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Week 24 breathing ambient air (n=19,21)
|
729.9 dyn*s/cm^5
Standard Deviation 230.1
|
1017.0 dyn*s/cm^5
Standard Deviation 369.1
|
|
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (1st) (n=9,14)
|
706.9 dyn*s/cm^5
Standard Deviation 285.5
|
1000.6 dyn*s/cm^5
Standard Deviation 501.5
|
|
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (2nd) (n=9,11)
|
687.4 dyn*s/cm^5
Standard Deviation 276.3
|
1033.6 dyn*s/cm^5
Standard Deviation 546.2
|
|
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Week 24 5 mins after NO administration (n=10,12)
|
717.2 dyn*s/cm^5
Standard Deviation 271.6
|
987.8 dyn*s/cm^5
Standard Deviation 370.4
|
|
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion
Week 24 15 mins after NO administration (n=10,14)
|
776.1 dyn*s/cm^5
Standard Deviation 286.8
|
1042.5 dyn*s/cm^5
Standard Deviation 388.4
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Baseline breathing ambient air (n=26,26)
|
1674.4 dyn*s/cm^5
Standard Deviation 761.2
|
1764.8 dyn*s/cm^5
Standard Deviation 481.9
|
|
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Baseline every 2 mins breathing NO (1st) (n=18,15)
|
1778.2 dyn*s/cm^5
Standard Deviation 709.5
|
1769.7 dyn*s/cm^5
Standard Deviation 457.0
|
|
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Baseline every 2 mins breathing NO (2nd) (n=16,14)
|
1807.3 dyn*s/cm^5
Standard Deviation 615.1
|
1664.7 dyn*s/cm^5
Standard Deviation 472.0
|
|
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Baseline 5 mins after NO administration (n=18,11)
|
1609.2 dyn*s/cm^5
Standard Deviation 593.4
|
1666.6 dyn*s/cm^5
Standard Deviation 488.6
|
|
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Baseline 15 mins after NO administration(n=17,15)
|
1976.3 dyn*s/cm^5
Standard Deviation 877.5
|
1748.4 dyn*s/cm^5
Standard Deviation 499.3
|
|
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Week 24 breathing ambient air (n=18,21)
|
1427.2 dyn*s/cm^5
Standard Deviation 446.8
|
1667.9 dyn*s/cm^5
Standard Deviation 357.8
|
|
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (1st) (n=9,13)
|
1344.2 dyn*s/cm^5
Standard Deviation 474.8
|
1579.3 dyn*s/cm^5
Standard Deviation 386.8
|
|
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Week 24 every 2 mins breathing NO (2nd) (n=9,11)
|
1367.9 dyn*s/cm^5
Standard Deviation 601.7
|
1592.5 dyn*s/cm^5
Standard Deviation 389.0
|
|
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Week 24 5 mins after NO administration (n=9,12)
|
1419.7 dyn*s/cm^5
Standard Deviation 566.6
|
1503.9 dyn*s/cm^5
Standard Deviation 305.3
|
|
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion
Week 24 15 mins after NO administration (n=10,14)
|
1431.7 dyn*s/cm^5
Standard Deviation 524.4
|
1629.3 dyn*s/cm^5
Standard Deviation 355.6
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Blood Gas Measurement - PaO2 at Baseline and Study Completion
Baseline n=22,21
|
63.36 mmHg
Standard Deviation 14.33
|
63.75 mmHg
Standard Deviation 12.02
|
|
Blood Gas Measurement - PaO2 at Baseline and Study Completion
Week 24 n=16,17
|
72.49 mmHg
Standard Deviation 14.09
|
70.13 mmHg
Standard Deviation 16.72
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Blood Gas Measurement - PaCO2 at Baseline and Study Completion
Baseline n=23,21
|
32.70 mmHg
Standard Deviation 4.40
|
30.02 mmHg
Standard Deviation 4.76
|
|
Blood Gas Measurement - PaCO2 at Baseline and Study Completion
Week 24 n=16,17
|
33.36 mmHg
Standard Deviation 5.11
|
30.23 mmHg
Standard Deviation 3.55
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Blood Gas Measurement - PvO2 at Baseline and Study Completion
Baseline n=14,14
|
33.16 mmHg
Standard Deviation 4.62
|
34.70 mmHg
Standard Deviation 4.75
|
|
Blood Gas Measurement - PvO2 at Baseline and Study Completion
Week 24 n=11,11
|
35.56 mmHg
Standard Deviation 3.80
|
32.65 mmHg
Standard Deviation 4.18
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion
Baseline n=19,16
|
87.99 percentage of saturation
Standard Deviation 9.19
|
91.81 percentage of saturation
Standard Deviation 4.05
|
|
Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion
Week 24 n=14,15
|
92.89 percentage of saturation
Standard Deviation 4.50
|
91.78 percentage of saturation
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Blood Gas Measurement - Venous Saturation at Baseline and Study Completion
Baseline n=17,14
|
57.96 percentage of saturation
Standard Deviation 10.48
|
60.84 percentage of saturation
Standard Deviation 6.61
|
|
Blood Gas Measurement - Venous Saturation at Baseline and Study Completion
Week 24 n=13,13
|
65.11 percentage of saturation
Standard Deviation 6.91
|
57.00 percentage of saturation
Standard Deviation 9.18
|
SECONDARY outcome
Timeframe: Baseline, and Study completion (Week 24)Population: The intention to treat population (ITT) will include all patients who received at least one dose of study medication.
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.
Outcome measures
| Measure |
STI571
n=28 Participants
STI571
|
Placebo
n=31 Participants
Placebo
|
|---|---|---|
|
Blood Gas Measurement - pH at Baseline and Study Completion
Baseline n=24,23
|
7.43 pH scale
Standard Deviation 0.04
|
7.44 pH scale
Standard Deviation 0.05
|
|
Blood Gas Measurement - pH at Baseline and Study Completion
Week 24 n=17,17
|
7.44 pH scale
Standard Deviation 0.05
|
7.46 pH scale
Standard Deviation 0.05
|
Adverse Events
Core - STI571
Serious events: 12 serious events
Other events: 26 other events
Deaths: 0 deaths
Core - Placebo
Serious events: 11 serious events
Other events: 25 other events
Deaths: 0 deaths
Extension - STI571
Serious events: 16 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Core - STI571
n=28 participants at risk
Core - STI571
|
Core - Placebo
n=31 participants at risk
Core - Placebo
|
Extension - STI571
n=22 participants at risk
Extension - STI571
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/28
|
3.2%
1/31
|
4.5%
1/22
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/22
|
|
Cardiac disorders
Cardiac arrest
|
7.1%
2/28
|
6.5%
2/31
|
0.00%
0/22
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/22
|
|
Cardiac disorders
Right ventricular failure
|
3.6%
1/28
|
6.5%
2/31
|
4.5%
1/22
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Ear and labyrinth disorders
Vertigo
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/22
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Gastrointestinal disorders
Pancreatitis
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/22
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
General disorders
Catheter related complication
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/22
|
|
General disorders
Disease progression
|
0.00%
0/28
|
0.00%
0/31
|
31.8%
7/22
|
|
General disorders
General physical health deterioration
|
0.00%
0/28
|
3.2%
1/31
|
0.00%
0/22
|
|
General disorders
Oedema peripheral
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
General disorders
Pyrexia
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Infections and infestations
Lung infection
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Investigations
Blood creatinine increased
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Investigations
Liver function test abnormal
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/28
|
6.5%
2/31
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/28
|
3.2%
1/31
|
4.5%
1/22
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28
|
3.2%
1/31
|
0.00%
0/22
|
|
Nervous system disorders
Presyncope
|
7.1%
2/28
|
3.2%
1/31
|
4.5%
1/22
|
|
Nervous system disorders
Syncope
|
7.1%
2/28
|
3.2%
1/31
|
13.6%
3/22
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/28
|
6.5%
2/31
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery aneurysm
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
7.1%
2/28
|
9.7%
3/31
|
4.5%
1/22
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Vascular disorders
Arterial rupture
|
3.6%
1/28
|
0.00%
0/31
|
0.00%
0/22
|
Other adverse events
| Measure |
Core - STI571
n=28 participants at risk
Core - STI571
|
Core - Placebo
n=31 participants at risk
Core - Placebo
|
Extension - STI571
n=22 participants at risk
Extension - STI571
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/28
|
0.00%
0/31
|
13.6%
3/22
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Cardiac disorders
Palpitations
|
10.7%
3/28
|
12.9%
4/31
|
18.2%
4/22
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/28
|
3.2%
1/31
|
9.1%
2/22
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/28
|
0.00%
0/31
|
13.6%
3/22
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
4/28
|
12.9%
4/31
|
36.4%
8/22
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/28
|
0.00%
0/31
|
18.2%
4/22
|
|
Eye disorders
Eye swelling
|
10.7%
3/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
4/28
|
0.00%
0/31
|
0.00%
0/22
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
2/28
|
3.2%
1/31
|
9.1%
2/22
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/28
|
3.2%
1/31
|
18.2%
4/22
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28
|
6.5%
2/31
|
9.1%
2/22
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
6/28
|
9.7%
3/31
|
40.9%
9/22
|
|
Gastrointestinal disorders
Dyspepsia
|
10.7%
3/28
|
6.5%
2/31
|
18.2%
4/22
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/28
|
9.7%
3/31
|
0.00%
0/22
|
|
Gastrointestinal disorders
Nausea
|
50.0%
14/28
|
16.1%
5/31
|
36.4%
8/22
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
6/28
|
3.2%
1/31
|
13.6%
3/22
|
|
General disorders
Asthenia
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/22
|
|
General disorders
Chest discomfort
|
7.1%
2/28
|
9.7%
3/31
|
18.2%
4/22
|
|
General disorders
Chest pain
|
3.6%
1/28
|
9.7%
3/31
|
4.5%
1/22
|
|
General disorders
Exercise tolerance decreased
|
3.6%
1/28
|
6.5%
2/31
|
0.00%
0/22
|
|
General disorders
Fatigue
|
10.7%
3/28
|
12.9%
4/31
|
13.6%
3/22
|
|
General disorders
General physical health deterioration
|
3.6%
1/28
|
0.00%
0/31
|
13.6%
3/22
|
|
General disorders
Oedema
|
3.6%
1/28
|
0.00%
0/31
|
36.4%
8/22
|
|
General disorders
Oedema peripheral
|
25.0%
7/28
|
16.1%
5/31
|
40.9%
9/22
|
|
General disorders
Pain
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
General disorders
Pyrexia
|
7.1%
2/28
|
0.00%
0/31
|
18.2%
4/22
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Infections and infestations
Bronchitis
|
0.00%
0/28
|
3.2%
1/31
|
9.1%
2/22
|
|
Infections and infestations
Cystitis
|
0.00%
0/28
|
3.2%
1/31
|
9.1%
2/22
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/28
|
3.2%
1/31
|
22.7%
5/22
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Infections and infestations
Herpes simplex
|
7.1%
2/28
|
3.2%
1/31
|
0.00%
0/22
|
|
Infections and infestations
Nasopharyngitis
|
21.4%
6/28
|
25.8%
8/31
|
63.6%
14/22
|
|
Infections and infestations
Oral candidiasis
|
7.1%
2/28
|
0.00%
0/31
|
0.00%
0/22
|
|
Infections and infestations
Respiratory tract infection
|
21.4%
6/28
|
3.2%
1/31
|
50.0%
11/22
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/28
|
0.00%
0/31
|
31.8%
7/22
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/28
|
6.5%
2/31
|
0.00%
0/22
|
|
Investigations
Blood amylase increased
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/28
|
3.2%
1/31
|
13.6%
3/22
|
|
Investigations
Blood creatinine increased
|
3.6%
1/28
|
0.00%
0/31
|
13.6%
3/22
|
|
Investigations
Blood potassium decreased
|
10.7%
3/28
|
0.00%
0/31
|
27.3%
6/22
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/28
|
3.2%
1/31
|
9.1%
2/22
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/28
|
0.00%
0/31
|
13.6%
3/22
|
|
Investigations
C-reactive protein increased
|
0.00%
0/28
|
3.2%
1/31
|
13.6%
3/22
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Investigations
Lipase increased
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Investigations
Platelet count decreased
|
7.1%
2/28
|
0.00%
0/31
|
4.5%
1/22
|
|
Investigations
Weight decreased
|
3.6%
1/28
|
0.00%
0/31
|
18.2%
4/22
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
2/28
|
0.00%
0/31
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
1/28
|
6.5%
2/31
|
18.2%
4/22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.9%
5/28
|
0.00%
0/31
|
13.6%
3/22
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
4/28
|
12.9%
4/31
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
4/28
|
0.00%
0/31
|
13.6%
3/22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28
|
3.2%
1/31
|
22.7%
5/22
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.7%
3/28
|
9.7%
3/31
|
4.5%
1/22
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28
|
9.7%
3/31
|
22.7%
5/22
|
|
Nervous system disorders
Headache
|
35.7%
10/28
|
19.4%
6/31
|
18.2%
4/22
|
|
Psychiatric disorders
Anxiety
|
3.6%
1/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Psychiatric disorders
Insomnia
|
3.6%
1/28
|
0.00%
0/31
|
18.2%
4/22
|
|
Psychiatric disorders
Sleep disorder
|
7.1%
2/28
|
0.00%
0/31
|
18.2%
4/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
2/28
|
19.4%
6/31
|
31.8%
7/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
2/28
|
16.1%
5/31
|
13.6%
3/22
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
2/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/28
|
0.00%
0/31
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
10.7%
3/28
|
0.00%
0/31
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
5/28
|
9.7%
3/31
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.7%
3/28
|
0.00%
0/31
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
7.1%
2/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Vascular disorders
Flushing
|
7.1%
2/28
|
9.7%
3/31
|
0.00%
0/22
|
|
Vascular disorders
Haematoma
|
3.6%
1/28
|
0.00%
0/31
|
9.1%
2/22
|
|
Vascular disorders
Hypotension
|
0.00%
0/28
|
0.00%
0/31
|
9.1%
2/22
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER