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) - ND
- Conditions
- Pulmonary arterial hypertension,MedDRA version: 9.1Level: PTClassification code 10037400
- Registration Number
- EUCTR2009-012057-38-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion: 1. Male or female 18 years of age or older 2. A current diagnosis of Pulmonary Arterial Hypertension according to the Dana Point 2008 Meeting 3. A PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies 4. WHO Functional Class II-IV 5. 6MWD ≥ 150 meters and ≤ 450 meters 6. Ability to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Women who are lactating or of child-bearing potential 2. With a QTcF > 450 msec for males and > 470 msec for females at screening 3. Having syncope in the 3 months prior to the screening visit 4. With a history of blood or bleeding disorder
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method