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

Stopped early · Phase 3

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT01392495

Run by

Novartis Pharmaceuticals

People needed

17

Starts

2011-06-01

Expected to finish

2014-03-01

Last updated by the study team

2015-08-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Mineola, New York, United States
• Novartis Investigative Site — Darlinghurst, New South Wales, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Vilnius, Lithuania
• Novartis Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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