Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

This study has been terminated.

(Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.)

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01392495

First received: July 11, 2011

Last updated: July 13, 2015

Last verified: July 2015

History of Changes

Purpose

This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: Imatinib	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

Drug Information available for: Imatinib Imatinib mesylate

Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension

U.S. FDA Resources

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:

Number of Patients With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: 144 weeks ]
Adverse event monitoring was conducted throughout the trial.

Secondary Outcome Measures:

Change From Baseline in the Six Minute Walk Distance (6MWD) [ Time Frame: baseline, 144 weeks ]
Time to Clinical Worsening (TTCW) Endpoints [ Time Frame: 144 weeks ]
Medical Resource Utilization [ Time Frame: 144 weeks ]


Enrollment:	17
Study Start Date:	June 2011
Study Completion Date:	March 2014
Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: QTI571 Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).	Drug: Imatinib 200 mg or 400 mg qd

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who completed in CQTI571A2102 clinical trial including all Study Completion assessments at the end of study visit met the eligibility criteria for that study and did not meet withdrawal criteria for safety reasons during study conduct

Exclusion Criteria:

Patients with left ventricular ejection fraction (LVEF) < 45%
Patients with thrombocytopenia, platelet count < 50 x109/L (50 x 103/µL).
Patients with uncontrolled systemic arterial hypertension, systolic pressure > 160 mmHg or diastolic pressure > 90 mmHg.
Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right bundle branch block.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392495

Locations


United States, New York
Novartis Investigative Site
Mineola, New York, United States, 11501
Australia, New South Wales
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Germany
Novartis Investigative Site
Hannover, Germany, 30625
Italy
Novartis Investigative Site
Roma, RM, Italy, 00161
Lithuania
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
United Kingdom
Novartis Investigative Site
London, United Kingdom, NW3 2QG

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Frost AE, Barst RJ, Hoeper MM, Chang HJ, Frantz RP, Fukumoto Y, Galié N, Hassoun PM, Klose H, Matsubara H, Morrell NW, Peacock AJ, Pfeifer M, Simonneau G, Tapson VF, Torres F, Dario Vizza C, Lawrence D, Yang W, Felser JM, Quinn DA, Ghofrani HA. Long-term safety and efficacy of imatinib in pulmonary arterial hypertension. J Heart Lung Transplant. 2015 Nov;34(11):1366-75. doi: 10.1016/j.healun.2015.05.025. Epub 2015 Jun 11.

Hoeper MM, Barst RJ, Bourge RC, Feldman J, Frost AE, Galié N, Gómez-Sánchez MA, Grimminger F, Grünig 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.


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01392495 History of Changes
Other Study ID Numbers:	CQTI571A2102E1 2010-021960-14 ( EudraCT Number )
Study First Received:	July 11, 2011
Results First Received:	March 24, 2015
Last Updated:	July 13, 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Pulmonary arterial hypertension imatinib 6MWD

Additional relevant MeSH terms:


Hypertension Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases	Respiratory Tract Diseases Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2017

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