Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
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| ClinicalTrials.gov Identifier: NCT01392495 |
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Recruitment Status :
Terminated
(Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.)
First Posted : July 12, 2011
Results First Posted : July 13, 2015
Last Update Posted : August 10, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Pulmonary Arterial Hypertension |
| Intervention |
Drug: Imatinib |
| Enrollment | 17 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | QTI571 |
|---|---|
 Arm/Group Description |
Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469). |
| Period Title: Overall Study | |
| Started | 17 |
| Received 200 mg | 4 |
| Received 400 mg | 13 |
| Completed | 1 |
| Not Completed | 16 |
| Reason Not Completed | |
| Death | 3 |
| Administrative problems | 8 |
| Withdrawal by Subject | 2 |
| Adverse Event | 3 |
Baseline Characteristics
| Arm/Group Title | QTI571 | |
|---|---|---|
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Arm/Group Description |
Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102. | |
| Overall Number of Baseline Participants | 17 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 17 participants | |
| 53.5 (14.3) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 17 participants | |
| Female |
11 64.7%
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| Male |
6 35.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-8300 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01392495 |
| Other Study ID Numbers: |
CQTI571A2102E1 2010-021960-14 ( EudraCT Number ) |
| First Submitted: | July 11, 2011 |
| First Posted: | July 12, 2011 |
| Results First Submitted: | March 24, 2015 |
| Results First Posted: | July 13, 2015 |
| Last Update Posted: | August 10, 2015 |