An Extension Study to QTI571A2301 to Evaluate the Long-Term Safety, Tolerability and Effectiveness of Imatinib in Severe Pulmonary Arterial Hypertension


About this study

The purpose of this extension study is to provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

This study has been terminated

Inclusion Criteria

  • Participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol, including all Study Completion assessments
  • 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

  • Had a pulmonary capillary wedge pressure > 15 mmHg at time of Study Completion assessments in core protocol CQTI571A2301
    • If pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place
  • LVEF < 45%
  • Has thrombocytopenia, platelet count < 50E9/L (50E3/µL)
  • Has uncontrolled systemic arterial hypertension, systolic > 160 mmHg or diastolic > 90 mmHg
  • Has 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)

Other protocol-defined inclusion/exclusion criteria may apply

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Robert Frantz, M.D.

Closed for enrollment

More information


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