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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QTI571

Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).

Group Type EXPERIMENTAL

Imatinib

Intervention Type DRUG

200 mg or 400 mg qd

Interventions

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Imatinib

200 mg or 400 mg qd

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No