Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) (IMPRES Extn)
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ClinicalTrials.gov Identifier: NCT01117987 |
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 : May 6, 2010
Results First Posted : May 21, 2015
Last Update Posted : August 13, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Tracking Information | ||||
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First Submitted Date ICMJE | May 3, 2010 | |||
First Posted Date ICMJE | May 6, 2010 | |||
Results First Submitted Date ICMJE | April 2, 2015 | |||
Results First Posted Date ICMJE | May 21, 2015 | |||
Last Update Posted Date | August 13, 2015 | |||
Study Start Date ICMJE | April 2010 | |||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Participants With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: 204 weeks ] Adverse event monitoring was conducted throughout the study.
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Original Primary Outcome Measures ICMJE |
Number of patients with Adverse Events as a measure of the safety and tolerability of QTI571 [ Time Frame: 672 days ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) | |||
Official Title ICMJE | An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension | |||
Brief Summary | This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Pulmonary Arterial Hypertension | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
144 | |||
Original Estimated Enrollment ICMJE |
160 | |||
Actual Study Completion Date ICMJE | April 2014 | |||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, Canada, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Spain, Switzerland, United Kingdom, United States | |||
Removed Location Countries | Sweden | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01117987 | |||
Other Study ID Numbers ICMJE | CQTI571A2301E1 2009-018167-26 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Novartis ( Novartis Pharmaceuticals ) | |||
Original Responsible Party | External Affairs, Novartis Pharmaceuticals | |||
Current Study Sponsor ICMJE | Novartis Pharmaceuticals | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | July 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |