QTI571 (Imatinib mesylate) in the treatment of PAH

• Research type

  Research Study

• Full title

  A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study (IMPRES)

• IRAS ID

  25181

• Contact name

  Nicholas Morrell

• Eudract number

  2009-012057-38

• ISRCTN Number

  N/A

• 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 the condition. The purpose of this research is to evaluate the efficacy, safety and tolerability of QTI571 (Imatinib) compared to placebo in the treatment of severe PAH. The patients in this trial must be taking 2 other medicines to treat their PAH and still be experiencing symptoms. The main measure of efficacy will be the change in 6-minute walk distance (6MWD) during the 24 weeks of treatment. Half of the patients in the study will receive placebo; the other half will receive Imatinib. Participants will take 4 tablets each day for 24 weeks. Those who receive active Imatinib will take 200mg per day for the first 2 weeks. If this is tolerated well, the dose will be increased to 400mg per day. The dose may be reduced back down to 200mg if 400mg is not well tolerated. Patients will continue to take their own supply of PAH medicines and other concomitant medications throughout the study. Patients will attend 12 study visits over a period of about 28 weeks. Patients who meet the general eligibility and medical history criteria will have the following safety and efficacy tests: 1. Collection of blood and urine samples (every visit) 2. Right heart catheterisation (Screening; Week 24) 3. ECG (every visit) 4. Echocardiogram (Screening; Weeks 12 & 24) 5. 6MWD (Screening; every 4 weeks thereafter until Week 24) Novartis Pharma AG is sponsoring this study. 200 patients (15 from the UK) are expected to take part.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/95

• Date of REC Opinion

  18 Aug 2009

• REC opinion

  Favourable Opinion