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Imatinib (QTI571) in Pulmonary Arterial Hypertension (IMPRES)

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ClinicalTrials.gov Identifier: NCT00902174
Recruitment Status : Completed
First Posted : May 15, 2009
Results First Posted : July 16, 2013
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Interventions Drug: imatinib mesylate
Drug: Placebo
Enrollment 202
Recruitment Details Overall, 326 participants were screened, 202 participants were randomized (103 to Imatinib and 99 to placebo). Out of 202 participants randomized 201 participants received study drug treatment (103 received imatinib mesylate, 98 received placebo). One participant was randomized to the placebo group but did not receive any study treatment.
Pre-assignment Details Participants were randomized in a 1:1 ratio to imatinib mesylate or placebo.
Arm/Group Title Imatinib Mesylate Placebo
Hide Arm/Group Description Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted. Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
Period Title: Overall Study
Started 103 99
Completed 69 81
Not Completed 34 18
Reason Not Completed
Adverse Event             27             7
Lack of Efficacy             1             5
Death             2             2
Withdrawal by Subject             2             1
Abnormal labs             1             1
Protocol Violation             1             1
Administration problem             0             1
Arm/Group Title Imatinib Mesylate Placebo Total
Hide Arm/Group Description Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted. Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments. Total of all reporting groups
Overall Number of Baseline Participants 103 99 202
Hide Baseline Analysis Population Description
Age set includes all randomized participants (202). Gender set includes all treated participants (201). One participant was randomized to placebo but did not receive stuy drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 99 participants 202 participants
50.0  (15.33) 46.5  (13.60) 48.3  (14.59)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants 99 participants 202 participants
Female 83 79 162
Male 20 19 39
[1]
Measure Description: One participant was randomized to placebo but did not receive study drug.
1.Primary Outcome
Title Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks
Hide Description This standardized walk course was 30 meters in length. During the walk the participant was connected to a portable pulse oximeter via a finger probe. Participants were instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. The total distance walked (in meters) was recorded. Results were compared between the 2 groups.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all participants who received at least one dose of study drug and completed the 6MWD Six-minute walk test at week 24. Repeated measurement model was used for this analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 92 93
Least Squares Mean (Standard Error)
Unit of Measure: meters
382.94  (9.790) 351.18  (9.834)
2.Secondary Outcome
Title Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases
Hide Description Clinical worsening per participant was measured by the onset of any adjudicated event (all cause mortality; overnight hospitalization for worsening of Pulmonary Arterial Hypertension (PAH); worsening of WHO functional class by one level; 15% decline in Six Minute Walk Distance (6MWD) measured on two consecutive occasions) at 24 weeks treatment, comparing imatinib to placebo groups. A cox regression analysis model was used.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included all participants who received at least one dose of study drug and experienced an adjudicated event. A cox regression analysis model was used.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 37 32
Measure Type: Number
Unit of Measure: percentage of participants
35.9 32.7
3.Secondary Outcome
Title Change From Baseline in Right Atrial Pressure
Hide Description Change from baseline in right atrial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The right atrial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher right atrial pressure number indicates worsening.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 73 81
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-1.02  (0.851) 0.68  (0.855)
4.Secondary Outcome
Title Change From Baseline in Mean Pulmonary Arterial Pressure
Hide Description Change from baseline in mean pulmonary arterial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The mean pulmonary arterial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher mean pulmonary arterial pressure number indicates worsening.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 75 82
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-3.54  (1.585) 1.63  (1.586)
5.Secondary Outcome
Title Change From Baseline in Mean Pulmonary Capillary Wedge Pressure
Hide Description Change from baseline in mean pulmonary capillary wedge pressure (mmHg)was measured via right heart catheterization according to the local hospital procedures. The right atrial mean pulmonary capillary wedge pressure was assessed when the participant was in a stable hemodynamic rest state.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 74 80
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
0.92  (0.693) -0.05  (0.701)
6.Secondary Outcome
Title Change From Baseline in Systemic Vascular Resistance
Hide Description Change from baseline in systemic vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The systemic vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in mean systemic vascular resistance indicates improvement.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 71 76
Least Squares Mean (Standard Error)
Unit of Measure: dynes*sec*cm^-5
-467.84  (78.577) -88.10  (77.183)
7.Secondary Outcome
Title Change From Baseline in Pulmonary Vascular Resistance
Hide Description Change from baseline in pulmonary vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The pulmonary vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in pulmonary vascular resistance indicates improvement.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 74 80
Least Squares Mean (Standard Error)
Unit of Measure: dynes*sec*cm^-5
-366.47  (67.673) 12.12  (68.963)
8.Secondary Outcome
Title Change From Baseline in Pulmonary Resistance Index
Hide Description Change from baseline in pulmonary resistance index (dynes*sec*cm^-5/m2) was measured via right heart catheterization according to the local hospital procedures. The pulmonary resistance index was assessed when the participant was in a stable hemodynamic rest state. A reduction from baseline in pulmonary resistance index indicates improvement.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 74 80
Least Squares Mean (Standard Error)
Unit of Measure: dynes*sec*cm^-5/m2
-221.29  (47.355) 21.92  (48.247)
9.Secondary Outcome
Title Change From Baseline in Cardiac Output
Hide Description Change from baseline in cardiac output (L/min) was measured via right heart catheterization according to the local hospital procedures. The cardiac output was assessed when the participant was in a stable hemodynamic rest state. An increase from baseline (higher number) in cardiac output indicates improvement.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 75 81
Least Squares Mean (Standard Error)
Unit of Measure: Liters/minute
1.17  (0.182) 0.29  (0.186)
10.Secondary Outcome
Title Change From Baseline in Systolic Arterial Blood Pressure
Hide Description Change from baseline in systolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The systolic arterial blood was assessed when the participant was in a stable hemodynamic rest state.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 73 78
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-2.92  (2.298) -1.15  (2.227)
11.Secondary Outcome
Title Change From Baseline in Diastolic Arterial Blood Pressure
Hide Description Change from baseline in diastolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The diastolic arterial blood pressure was assessed when the participant was in a stable hemodynamic rest state.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 72 78
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-3.81  (1.958) -1.48  (1.909)
12.Secondary Outcome
Title Change From Baseline in Heart Rate
Hide Description Change from baseline in heart rate (bpm) was measured via right heart catheterization according to the local hospital procedures. The heart rate was assessed when the participant was in a stable hemodynamic rest state.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 73 77
Least Squares Mean (Standard Error)
Unit of Measure: bpm
0.38  (12.63) 0.73  (2.255)
13.Secondary Outcome
Title Change in Borg Dyspnea Score During 6-minute Walk Test
Hide Description Change in Borg scale was measured at different time points at week 24. The Borg Scale consists of scale range of 0 to 10. Participants pointed to indicate their level of dyspnea before and at the end of exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). A reduction in this score indicates an improvement.
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 92 91
Mean (Standard Deviation)
Unit of Measure: units on a scale
Resting (n= 86 imatinib; 89 placebo) -0.06  (1.097) -0.12  (1.142)
End of test (n= 92 imatinib; 91 placebo) -0.38  (2.009) -0.24  (2.093)
2 min after end (n= 82 imatinib; 81 placebo) -0.37  (1.409) -0.18  (1.550)
End of test - Resting (n= 81 imatinib; 81 placebo) -0.24  (1.193) -0.29  (1.279)
2 min after end - end of test (n= 82 ima; 81plb) -0.07  (1.533) -0.03  (1.743)
14.Secondary Outcome
Title Covariance of End of Study CAMPHOR Score
Hide Description The CAMPHOR test consists of 65 items and 3 scales. Two scales measure Health Related Quality of Life. 1) Symptoms: consists of 25 items measuring loss or abnormality of psychological, physiological or anatomical structure or function; further sub-divided into 3 subscales (energy, breathlessness and mood), 2) Disability: consists of 15 items measuring any restriction or lack of ability to perform an activity. 3) Quality of Life (QOL): consists of 25 items defining how individuals perceived ability and capacity to satisfy their needs. The 25-item symptom and QOL scales score from 0-25 where a higher score indicates the presence of more symptoms and poor QOL, respectively. The 15-item functioning scale scores 0-30; a higher score indicates poor functioning.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
imatinib mesylate
Placebo to imatinib
Overall Number of Participants Analyzed 45 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Symptoms score 7.93  (1.372) 9.03  (1.431)
Activity score 8.99  (1.177) 10.55  (1.223)
Quality of life score 7.45  (1.026) 7.13  (1.066)
15.Secondary Outcome
Title Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Hide Description

Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.

The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay.

Time Frame predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.
Arm/Group Title Imatinib 200 mg GCP74588
Hide Arm/Group Description:
imatinib mesylate 200 mg once daily
imatinib metabolite
Overall Number of Participants Analyzed 77 77
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 - predose (n=77 imat; n=77 GCP) 0  (0) 0  (0)
Day 1 - 0-3h post-dose (n=77 imat; n=77 GCP) 471.9  (560.1) 61.8  (77.6)
Day 14 - predose (n=18 imat; n=18 GCP) 579.6  (384.9) 178.8  (122.8)
Day 14 - 0-3h post-dose (n=19 imat; n=19 GCP) 1005.7  (665.6) 233.8  (170.9)
Day 28 - predose (n=20 imat; n=20 GCP) 658.8  (450.3) 228.6  (121.4)
Day 28 - 0-3h post-dose (n=19 imat; n=19 GCP) 1438.6  (924.4) 323.9  (150.6)
Day 168 predose (n=24 imat; n=24 GCP) 398.6  (415.5) 126.6  (83.3)
Day 168- 0-3h post-dose (n=23 imat; n=23 GCP) 710.8  (639.7) 166.1  (103.1)
16.Secondary Outcome
Title Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant
Hide Description

Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.

The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay.

Time Frame predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.
Arm/Group Title Imatinib 400 mg GCP74588
Hide Arm/Group Description:
imatinib mesylate 400 mg once daily
imatinib metabolite
Overall Number of Participants Analyzed 62 62
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 - predose (n=12 imat; n=12 GCP) 0  (0) 0  (0)
Day 1 - 0-3h post-dose (n=13 imat; n=13 GCP) 843.2  (788.9) 109.9  (132.4)
Day 14 - predose (n=62 imat; n=62 GCP) 516.5  (405.2) 155.1  (101.1)
Day 14 - 0-3h post-dose (n=62 imat; n=62 GCP) 1172.8  (1088.9) 233.7  (165.6)
Day 28 - predose (n=55 imat; n=55 GCP) 829.8  (482.6) 248.2  (125.2)
Day 28 - 0-3h post-dose (n=58 imat; n=58 GCP) 1335.3  (817.9) 320.7  (154.8)
Day 168 predose (n=36 imat; n=36 GCP) 869.9  (407.8) 241.4  (91.9)
Day 168- 0-3h post-dose (n=35 imat; n=35 GCP) 1616.1  (787.6) 348.0  (119.1)
Time Frame [Not Specified]
Adverse Event Reporting Description 202 participants were randomized (103 imatinib & 99 placebo; however, one participant who was randomized to the placebo group did not receive study drug and was excluded from this analysis set. The safety set includes all participants who received study drug = 201 (103 imatinib, 98 placebo).
 
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description imatinib mesylate Placebo to imatinib
All-Cause Mortality
Imatinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Imatinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   45/103 (43.69%)   29/98 (29.59%) 
Blood and lymphatic system disorders     
Anaemia  1  7/103 (6.80%)  1/98 (1.02%) 
Coagulopathy  1  1/103 (0.97%)  0/98 (0.00%) 
Neutropenia  1  2/103 (1.94%)  0/98 (0.00%) 
Thrombocytopenia  1  2/103 (1.94%)  0/98 (0.00%) 
Cardiac disorders     
Angina pectoris  1  2/103 (1.94%)  0/98 (0.00%) 
Atrial fibrillation  1  1/103 (0.97%)  1/98 (1.02%) 
Atrial flutter  1  2/103 (1.94%)  1/98 (1.02%) 
Cardiac failure  1  1/103 (0.97%)  0/98 (0.00%) 
Nodal arrhythmia  1  1/103 (0.97%)  0/98 (0.00%) 
Right ventricular failure  1  2/103 (1.94%)  2/98 (2.04%) 
Tricuspid valve incompetence  1  1/103 (0.97%)  0/98 (0.00%) 
Eye disorders     
Periorbital oedema  1  1/103 (0.97%)  0/98 (0.00%) 
Retinal detachment  1  1/103 (0.97%)  0/98 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/103 (0.97%)  0/98 (0.00%) 
Diarrhoea  1  3/103 (2.91%)  2/98 (2.04%) 
Gastritis  1  1/103 (0.97%)  0/98 (0.00%) 
Gastrointestinal haemorrhage  1  1/103 (0.97%)  1/98 (1.02%) 
Haemorrhoidal haemorrhage  1  1/103 (0.97%)  0/98 (0.00%) 
Melaena  1  1/103 (0.97%)  0/98 (0.00%) 
Nausea  1  2/103 (1.94%)  1/98 (1.02%) 
Vomiting  1  1/103 (0.97%)  0/98 (0.00%) 
General disorders     
Catheter site haemorrhage  1  1/103 (0.97%)  0/98 (0.00%) 
Device leakage  1  0/103 (0.00%)  1/98 (1.02%) 
Face oedema  1  1/103 (0.97%)  0/98 (0.00%) 
Fatigue  1  1/103 (0.97%)  0/98 (0.00%) 
Injection site extravasation  1  0/103 (0.00%)  1/98 (1.02%) 
Medical device complication  1  1/103 (0.97%)  1/98 (1.02%) 
Non-cardiac chest pain  1  0/103 (0.00%)  2/98 (2.04%) 
Oedema peripheral  1  6/103 (5.83%)  0/98 (0.00%) 
Pyrexia  1  0/103 (0.00%)  1/98 (1.02%) 
Hepatobiliary disorders     
Hepatic congestion  1  1/103 (0.97%)  0/98 (0.00%) 
Jaundice  1  1/103 (0.97%)  0/98 (0.00%) 
Infections and infestations     
Bacteraemia  1  1/103 (0.97%)  0/98 (0.00%) 
Campylobacter infection  1  0/103 (0.00%)  1/98 (1.02%) 
Clostridial infection  1  0/103 (0.00%)  1/98 (1.02%) 
Device related infection  1  3/103 (2.91%)  0/98 (0.00%) 
Enterocolitis infectious  1  0/103 (0.00%)  1/98 (1.02%) 
Gastroenteritis  1  0/103 (0.00%)  2/98 (2.04%) 
Gastroenteritis bacterial  1  1/103 (0.97%)  0/98 (0.00%) 
Infection  1  0/103 (0.00%)  1/98 (1.02%) 
Lower respiratory tract infection  1  0/103 (0.00%)  1/98 (1.02%) 
Lung infection  1  0/103 (0.00%)  1/98 (1.02%) 
Pneumonia  1  1/103 (0.97%)  2/98 (2.04%) 
Pneumonia primary atypical  1  0/103 (0.00%)  1/98 (1.02%) 
Pyelonephritis acute  1  1/103 (0.97%)  0/98 (0.00%) 
Respiratory tract infection  1  0/103 (0.00%)  1/98 (1.02%) 
Sepsis  1  2/103 (1.94%)  0/98 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/103 (0.97%)  0/98 (0.00%) 
Fall  1  1/103 (0.97%)  0/98 (0.00%) 
Head injury  1  1/103 (0.97%)  0/98 (0.00%) 
Subdural haematoma  1  1/103 (0.97%)  0/98 (0.00%) 
Subdural haemorrhage  1  1/103 (0.97%)  0/98 (0.00%) 
Investigations     
Cardiac output decreased  1  0/103 (0.00%)  1/98 (1.02%) 
International normalised ratio increased  1  1/103 (0.97%)  0/98 (0.00%) 
Right atrial pressure increased  1  1/103 (0.97%)  0/98 (0.00%) 
Metabolism and nutrition disorders     
Electrolyte imbalance  1  1/103 (0.97%)  0/98 (0.00%) 
Fluid overload  1  1/103 (0.97%)  1/98 (1.02%) 
Hypervolaemia  1  1/103 (0.97%)  0/98 (0.00%) 
Hypokalaemia  1  2/103 (1.94%)  0/98 (0.00%) 
Hyponatraemia  1  1/103 (0.97%)  1/98 (1.02%) 
Hypovolaemia  1  1/103 (0.97%)  0/98 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/103 (0.97%)  0/98 (0.00%) 
Myalgia  1  0/103 (0.00%)  1/98 (1.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/103 (0.00%)  1/98 (1.02%) 
Nervous system disorders     
Dizziness  1  1/103 (0.97%)  0/98 (0.00%) 
Headache  1  1/103 (0.97%)  0/98 (0.00%) 
Presyncope  1  5/103 (4.85%)  0/98 (0.00%) 
Syncope  1  1/103 (0.97%)  5/98 (5.10%) 
Renal and urinary disorders     
Renal failure  1  1/103 (0.97%)  1/98 (1.02%) 
Renal failure acute  1  1/103 (0.97%)  0/98 (0.00%) 
Renal impairment  1  1/103 (0.97%)  0/98 (0.00%) 
Reproductive system and breast disorders     
Menorrhagia  1  1/103 (0.97%)  0/98 (0.00%) 
Uterine haemorrhage  1  1/103 (0.97%)  0/98 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  0/103 (0.00%)  1/98 (1.02%) 
Bronchial haemorrhage  1  0/103 (0.00%)  1/98 (1.02%) 
Dyspnoea  1  6/103 (5.83%)  2/98 (2.04%) 
Epistaxis  1  1/103 (0.97%)  0/98 (0.00%) 
Haemoptysis  1  0/103 (0.00%)  2/98 (2.04%) 
Hypoxia  1  1/103 (0.97%)  1/98 (1.02%) 
Pleural effusion  1  2/103 (1.94%)  1/98 (1.02%) 
Pneumonitis  1  1/103 (0.97%)  0/98 (0.00%) 
Pulmonary arterial hypertension  1  4/103 (3.88%)  4/98 (4.08%) 
Pulmonary fibrosis  1  1/103 (0.97%)  0/98 (0.00%) 
Pulmonary hypertension  1  2/103 (1.94%)  4/98 (4.08%) 
Pulmonary veno-occlusive disease  1  1/103 (0.97%)  0/98 (0.00%) 
Respiratory failure  1  1/103 (0.97%)  2/98 (2.04%) 
Vascular disorders     
Haematoma  1  1/103 (0.97%)  0/98 (0.00%) 
Hypertension  1  1/103 (0.97%)  0/98 (0.00%) 
Hypertensive crisis  1  0/103 (0.00%)  1/98 (1.02%) 
Hypoperfusion  1  1/103 (0.97%)  0/98 (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%
Imatinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   96/103 (93.20%)   80/98 (81.63%) 
Blood and lymphatic system disorders     
Anaemia  1  8/103 (7.77%)  2/98 (2.04%) 
Cardiac disorders     
Palpitations  1  4/103 (3.88%)  7/98 (7.14%) 
Eye disorders     
Periorbital oedema  1  30/103 (29.13%)  7/98 (7.14%) 
Gastrointestinal disorders     
Abdominal distension  1  9/103 (8.74%)  3/98 (3.06%) 
Abdominal pain  1  6/103 (5.83%)  3/98 (3.06%) 
Abdominal pain upper  1  2/103 (1.94%)  6/98 (6.12%) 
Diarrhoea  1  33/103 (32.04%)  18/98 (18.37%) 
Dyspepsia  1  8/103 (7.77%)  5/98 (5.10%) 
Nausea  1  56/103 (54.37%)  23/98 (23.47%) 
Vomiting  1  30/103 (29.13%)  10/98 (10.20%) 
General disorders     
Face oedema  1  9/103 (8.74%)  1/98 (1.02%) 
Fatigue  1  10/103 (9.71%)  7/98 (7.14%) 
Non-cardiac chest pain  1  3/103 (2.91%)  5/98 (5.10%) 
Oedema peripheral  1  41/103 (39.81%)  20/98 (20.41%) 
Pyrexia  1  7/103 (6.80%)  3/98 (3.06%) 
Infections and infestations     
Device related infection  1  1/103 (0.97%)  5/98 (5.10%) 
Influenza  1  2/103 (1.94%)  5/98 (5.10%) 
Nasopharyngitis  1  18/103 (17.48%)  19/98 (19.39%) 
Respiratory tract infection  1  3/103 (2.91%)  7/98 (7.14%) 
Sinusitis  1  2/103 (1.94%)  6/98 (6.12%) 
Upper respiratory tract infection  1  5/103 (4.85%)  7/98 (7.14%) 
Urinary tract infection  1  4/103 (3.88%)  5/98 (5.10%) 
Investigations     
Blood creatinine increased  1  9/103 (8.74%)  1/98 (1.02%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  14/103 (13.59%)  3/98 (3.06%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  10/103 (9.71%)  2/98 (2.04%) 
Pain in extremity  1  5/103 (4.85%)  6/98 (6.12%) 
Nervous system disorders     
Dizziness  1  8/103 (7.77%)  5/98 (5.10%) 
Headache  1  25/103 (24.27%)  22/98 (22.45%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  11/103 (10.68%)  15/98 (15.31%) 
Dyspnoea  1  13/103 (12.62%)  11/98 (11.22%) 
Epistaxis  1  7/103 (6.80%)  7/98 (7.14%) 
Nasal congestion  1  6/103 (5.83%)  4/98 (4.08%) 
Oropharyngeal pain  1  9/103 (8.74%)  6/98 (6.12%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  7/103 (6.80%)  1/98 (1.02%) 
Pruritus  1  3/103 (2.91%)  5/98 (5.10%) 
Rash  1  9/103 (8.74%)  2/98 (2.04%) 
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
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Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00902174     History of Changes
Other Study ID Numbers: CQTI571A2301
First Submitted: May 13, 2009
First Posted: May 15, 2009
Results First Submitted: April 16, 2013
Results First Posted: July 16, 2013
Last Update Posted: February 17, 2016