Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
202 participants
INTERVENTIONAL
2009-09-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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imatinib mesylate
Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
imatinib mesylate
Two or 4 imatinib mesylate (QTI571) 100 mg film coated tablets once daily.
Placebo
Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
Placebo
Placebo to imatinib 100 mg film coated tablets
Interventions
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imatinib mesylate
Two or 4 imatinib mesylate (QTI571) 100 mg film coated tablets once daily.
Placebo
Placebo to imatinib 100 mg film coated tablets
Eligibility Criteria
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Inclusion Criteria
* A Pulmonary Vascular Resistance (PVR) ≥ 800 dynes.sec.cm-5 (as assessed by Right Heart Catheterization (RHC) at screening or in the 3 months preceding the screening visit) despite treatment with two or more specific PAH therapies, including Endothelin Receptor Antagonists (ERAs), phosphodiesterase 5 inhibitors (PDE5), or subcutaneous, inhaled, intravenous or oral prostacyclin analogues for ≥ 3 months. Background therapy doses were to be stable for ≥ 30 days except for warfarin and prostacyclin analogues ( ≥ 30 days but doses could vary even within the month before enrollment).
* World Health Organization functional Class II-IV. For WHO Functional Class IV, one of the 2 or more specific PAH therapies were to be an inhaled, subcutaneous, intravenous or oral prostacyclin analogue, unless the subject showed intolerance of prostacyclin analogues.
* 6MWD ≥ 150 meters and ≤ 450 meters at screening. Distances of two consecutive 6MWTs were to be within 15% of one another.
Exclusion Criteria
* With a diagnosis of pulmonary artery or vein stenosis
* Left ventricular ejection fraction (LVEF) \< 45%
* With Disseminated Intravascular Coagulation (DIC)
* With evidence of major bleeding or intracranial hemorrhage
* With a history of elevated intracranial pressure
* With a history of latent bleeding risk such as diabetic retinopathy, gastrointestinal bleeding due to gastric or duodenal ulcers, or colitis ulcerosa
* With a QTcF \> 450 msec for males and \> 470 msec for females at screening and baseline in the absence of right bundle branch block.
* With a history of ventricular tachycardia, ventricular fibrillation or ventricular flutter
* With a history of Torsades de Pointes
* With a history of long QT syndrome
* Having undergone atrial septostomy in the 3 months prior to the screening visit
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
Bern, , Switzerland
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Lausanne, , Switzerland
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Sankt Gallen, , Switzerland
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Cambridge, , United Kingdom
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Clydebank, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Sheffield, , United Kingdom
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Clearwater, Florida, United States
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Miami Beach, Florida, United States
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Weston, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Minneola, New York, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Milwaukee, Wisconsin, United States
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Innsbruck, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Leuven, , Belgium
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Calgary, , Canada
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Edmonton, , Canada
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London, , Canada
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Montreal, , Canada
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Ottawa, , Canada
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Toronto, , Canada
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Vancouver, , Canada
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Clamart, , France
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Berlin, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Giessen, , Germany
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Greifswald, , 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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Löwenstein, , Germany
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München, , Germany
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Regensberg, , Germany
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Würzberg, , Germany
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Bologna, , Italy
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Pavia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Bunkyō City, , Japan
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Hamamatsu, , Japan
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Mitaka, , Japan
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Okayama, , Japan
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Sendai, , Japan
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Suita, , Japan
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Amsterdam, , Netherlands
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Seoul, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Caceras, , Spain
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Las Palmas de Gran Canarias, , Spain
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Madrid, , Spain
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Málaga, , Spain
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San Cristóbal de La Laguna, , Spain
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Santa Cruz de Tenerife, , Spain
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Santander, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Lund, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
Novartis Investigative Site
Uppsala, , Sweden
University Hospital Basel
Basel, , Switzerland
Countries
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References
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Querejeta Roca G, Campbell P, Claggett B, Solomon SD, Shah AM. Right Atrial Function in Pulmonary Arterial Hypertension. Circ Cardiovasc Imaging. 2015 Nov;8(11):e003521; discussion e003521. doi: 10.1161/CIRCIMAGING.115.003521.
Querejeta Roca G, Campbell P, Claggett B, Vazir A, Quinn D, Solomon SD, Shah AM. Impact of lowering pulmonary vascular resistance on right and left ventricular deformation in pulmonary arterial hypertension. Eur J Heart Fail. 2015 Jan;17(1):63-73. doi: 10.1002/ejhf.177. Epub 2014 Nov 4.
Shah AM, Campbell P, Rocha GQ, Peacock A, Barst RJ, Quinn D, Solomon SD; IMPRES Investigators. Effect of imatinib as add-on therapy on echocardiographic measures of right ventricular function in patients with significant pulmonary arterial hypertension. Eur Heart J. 2015 Mar 7;36(10):623-32. doi: 10.1093/eurheartj/ehu035. Epub 2014 Feb 23.
Hoeper MM, Barst RJ, Bourge RC, Feldman J, Frost AE, Galie N, Gomez-Sanchez MA, Grimminger F, Grunig E, Hassoun PM, Morrell NW, Peacock AJ, Satoh T, Simonneau G, Tapson VF, Torres F, Lawrence D, Quinn DA, Ghofrani HA. Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: results of the randomized IMPRES study. Circulation. 2013 Mar 12;127(10):1128-38. doi: 10.1161/CIRCULATIONAHA.112.000765. Epub 2013 Feb 12.
Related Links
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Related Info
Other Identifiers
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CQTI571A2301
Identifier Type: -
Identifier Source: org_study_id
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