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To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.
This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QTI571 | Experimental | Participants will receive QTI571 during 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QTI571 | Drug | QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects. | Approximately 2.9 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Sendai | Miyagi | 980-8574 | Japan | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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8 participants entered this study after completing the CQTI571A2301E1 study. All 8 participants discontinued study prematurely.
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| ID | Title | Description |
|---|---|---|
| FG000 | QTI571 | Participants received QTI571 during 3 years |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | QTI571 | Participants received QTI571 during 3 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serious Adverse Events | All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects. | Posted | Number | participants | Approximately 2.9 years |
|
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Adverse events were collected up to approximately 2.9 years
AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 2.9 years. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 2.9 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QTI571 | QTI571 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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No efficacy data was captured in this study, and no analysis of efficacy was planned. No formal analyses of Adverse Events were undertaken.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | (862) 778-8300 | Novartis.email@novartis.com |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment
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| Bunkyo-ku |
| Tokyo |
| 113-8655 |
| Japan |
| Novartis Investigative Site | Mitaka | Tokyo | 181-8611 | Japan |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 5 |
| 8 |
| 0 |
| 8 |
| Right ventricular failure | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Device connection issue | Product Issues | MedDRA (19.1) | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA (19.1) | Systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.