This trial is active, not recruiting.

Condition pulmonary arterial hypertension
Treatments imatinib
Phase phase 3
Target BCR-ABL
Sponsor Novartis Pharmaceuticals
Start date April 2010
End date February 2014
Trial size 145 participants
Trial identifier NCT01117987, 2009-018167-26, CQTI571A2301E1


This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Number of patients with Adverse Events as a measure of the safety and tolerability of QTI571
time frame: 672 days

Secondary Outcomes

Change in Six-Minute Walk Distance (6MWD) from baseline
time frame: 672 days
Time to clinical worsening (TTCW) endpoints
time frame: 672 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol, including all Study Completion assessments - Patients who 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: - Patients with 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% - Patients with thrombocytopenia, platelet count < 50E9/L (50E3/µL) - Patients with uncontrolled systemic arterial hypertension, systolic > 160 mmHg or diastolic > 90 mmHg - Patients with 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

Additional Information

Official title An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Novartis.