Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT01117987
Last Updated: 2015-08-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
144 participants
INTERVENTIONAL
2010-04-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Core imatinib
Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Imatinib
Participants, who received imatinib 200 mg in the core study, CQTI571A2301 (NCT00902174), and completed the core study, received imatinib 200 mg every day (qd) in the extension. Participants, who were randomized to receive imatinib 400 mg in the core study and completed the core study, received imatinib 400 mg qd in the extension. Participants, who terminated early from the core study or who were randomized to placebo and completed the core study, started the extension with imatinib 200 mg qd. After 2 weeks, the dose was increased to 400 mg qd if tolerated.
Placebo
To preserve the blind of the core study until the core study, CQTI571A2301 (NCT00902174), was completed, participants received a blinded study drug package containing a 70-tablet bottle of imatinib and a 70-tablet bottle of matching placebo.
Core placebo
Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Imatinib
Participants, who received imatinib 200 mg in the core study, CQTI571A2301 (NCT00902174), and completed the core study, received imatinib 200 mg every day (qd) in the extension. Participants, who were randomized to receive imatinib 400 mg in the core study and completed the core study, received imatinib 400 mg qd in the extension. Participants, who terminated early from the core study or who were randomized to placebo and completed the core study, started the extension with imatinib 200 mg qd. After 2 weeks, the dose was increased to 400 mg qd if tolerated.
Placebo
To preserve the blind of the core study until the core study, CQTI571A2301 (NCT00902174), was completed, participants received a blinded study drug package containing a 70-tablet bottle of imatinib and a 70-tablet bottle of matching placebo.
Interventions
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Imatinib
Participants, who received imatinib 200 mg in the core study, CQTI571A2301 (NCT00902174), and completed the core study, received imatinib 200 mg every day (qd) in the extension. Participants, who were randomized to receive imatinib 400 mg in the core study and completed the core study, received imatinib 400 mg qd in the extension. Participants, who terminated early from the core study or who were randomized to placebo and completed the core study, started the extension with imatinib 200 mg qd. After 2 weeks, the dose was increased to 400 mg qd if tolerated.
Placebo
To preserve the blind of the core study until the core study, CQTI571A2301 (NCT00902174), was completed, participants received a blinded study drug package containing a 70-tablet bottle of imatinib and a 70-tablet bottle of matching placebo.
Eligibility Criteria
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Inclusion Criteria
* Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related to study drug or not related to a safety issue but performed all Study Completion assessments
Exclusion Criteria
* LVEF \< 45%
* Patients with thrombocytopenia, platelet count \< 50E9/L (50E3/µL)
* Patients with uncontrolled systemic arterial hypertension, systolic \> 160 mmHg or diastolic \> 90 mmHg
* Patients with a QTcF \> 450 ms for males and \> 470 ms for females in the absence of right branch bundle block (based on Visit 1 ECG if required to be performed)
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
Weston, Florida, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
Novartis Investigative Site
Mineola, New York, United States
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New York, New York, United States
Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Tualatin, Oregon, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Milwaulkee, Wisconsin, United States
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Clamart, , France
Novartis Investigative Site
Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
Novartis Investigative Site
Dresden, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Homburg, , Germany
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Marburg, , Germany
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München, , Germany
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Regensburg, , Germany
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Würzburg, , Germany
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Pavia, (pv), Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Okayama, Okayama-ken, Japan
Novartis Investigative Site
Hamamatsu, Shizuoka, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
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Mitaka, Tokyo, Japan
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Amsterdam, , Netherlands
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
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Seoul, Korea, South Korea
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Seville, Andalusia, Spain
Novartis Investigative Site
Santander, Cantabria, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, Madrid, Spain
Novartis Investigative Site
Sankt Gallen, , Switzerland
Novartis Investigative Site
Cambridge, Cambridgeshire, United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, Newcastle, United Kingdom
Novartis Investigative Site
Sheffield, South Yorkshire, United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Other Identifiers
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2009-018167-26
Identifier Type: -
Identifier Source: secondary_id
CQTI571A2301E1
Identifier Type: -
Identifier Source: org_study_id
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