Pulmonary Arterial Hypertension
Conditions
Keywords
Pulmonary arterial hypertension, imatinib, 6MWD
Brief summary
This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.
Interventions
DRUGImatinib
200 mg or 400 mg qd
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who completed in CQTI571A2102 clinical trial including all Study Completion assessments at the end of study visit met the eligibility criteria for that study and did not meet withdrawal criteria for safety reasons during study conduct
Exclusion criteria
* Patients with left ventricular ejection fraction (LVEF) \< 45% * Patients with thrombocytopenia, platelet count \< 50 x109/L (50 x 103/µL). * Patients with uncontrolled systemic arterial hypertension, systolic pressure \> 160 mmHg or diastolic pressure \> 90 mmHg. * Patients with a QTcF \> 450 ms for males and \> 470 ms for females in the absence of right bundle branch block. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events, Serious Adverse Events and Deaths | 144 weeks | Adverse event monitoring was conducted throughout the trial. |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in the Six Minute Walk Distance (6MWD) | baseline, 144 weeks |
| Time to Clinical Worsening (TTCW) Endpoints | 144 weeks |
| Medical Resource Utilization | 144 weeks |
Countries
Australia, Belgium, Germany, Italy, Lithuania, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| QTI571 Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative problems | 8 |
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | QTI571 |
|---|---|
| Age, Continuous | 53.5 Years STANDARD_DEVIATION 14.3 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 4 | 13 / 13 |
| serious Total, serious adverse events | 4 / 4 | 5 / 13 |
Outcome results
Primary
Number of Patients With Adverse Events, Serious Adverse Events and Deaths
Adverse event monitoring was conducted throughout the trial.
Time frame: 144 weeks
Population: Safety Analysis Set: The safety analysis set included all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QTI571 200 mg | Number of Patients With Adverse Events, Serious Adverse Events and Deaths | Adverse Events (serious and non-serious) | 4 Participants |
| QTI571 200 mg | Number of Patients With Adverse Events, Serious Adverse Events and Deaths | Deaths | 2 Participants |
| QTI571 200 mg | Number of Patients With Adverse Events, Serious Adverse Events and Deaths | Serious Adverse Events | 4 Participants |
| QTI571 400 mg | Number of Patients With Adverse Events, Serious Adverse Events and Deaths | Deaths | 1 Participants |
| QTI571 400 mg | Number of Patients With Adverse Events, Serious Adverse Events and Deaths | Adverse Events (serious and non-serious) | 13 Participants |
| QTI571 400 mg | Number of Patients With Adverse Events, Serious Adverse Events and Deaths | Serious Adverse Events | 5 Participants |
Secondary
Change From Baseline in the Six Minute Walk Distance (6MWD)
Time frame: baseline, 144 weeks
Population: The study terminated early. No statistical analysis was performed on the efficacy outcomes.
Secondary
Medical Resource Utilization
Time frame: 144 weeks
Population: The study terminated early. No statistical analysis was performed on the efficacy outcomes.
Secondary
Time to Clinical Worsening (TTCW) Endpoints
Time frame: 144 weeks
Population: The study terminated early. No statistical analysis was performed on the efficacy outcomes.