Extension study using imatinib mesylate in the treatment of PAH
Research type
Research Study
Full title
An extension study 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
IRAS ID
56065
Contact name
Amr Radwan
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2009-018167-26
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Pulmonary arterial hypertension (PAH) is a serious life-limiting condition caused by an increase in the pressure within the arteries that carry blood from the heart to the lungs. This puts strain on the right side of the heart, resulting in heart failure and premature death. Although several therapies are available, there is no known cure. It is estimated that approximately 2000 people in the UK suffer from PAH.The purpose of this research is to evaluate the long term efficacy, safety and tolerability of QTI571 (Imatinib) in the treatment of severe PAH. The patients in this trial must have either completed the core study (CQTI571A2301) or been withdrawn for reasons not related to safety or the study drug QTI571. For patients who discontinued early from the core study, participation in the extension will begin 24 weeks after the first core study dose. Efficacy will be measured by the change in 6-minute walk distance (6MWD).Participants will continue taking the dose of imatinib that they were taking when they completed the core study CQTI571A2301. Patients who were randomised to placebo or who discontinued early will begin the extension study at 200mg per day. If tolerated, this will be increased to 400mg after 2 weeks. Dose reduction to 200mg will be permitted if 400mg is not tolerated. If 200mg is not tolerated, the patient will be discontinued from treatment and from the study.Patients will continue to take their own regular PAH medicines and other concomitant medications throughout the study.Patients will attend 5 study visits during the first 12 weeks. Thereafter, visits will be every 6 months.Patients will have the following safety and efficacy tests: 1. Collection of blood and urine samples2. ECG4. Echocardiogram5. 6-Minute Walk TestNovartis Pharma AG is sponsoring this study. Approximately 140 patients (12 from the UK) are expected to take part.
REC name
London - Fulham Research Ethics Committee
REC reference
10/H0711/54
Date of REC Opinion
9 Jul 2010
REC opinion
Further Information Favourable Opinion