An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension.
Phase 3
Completed
- Conditions
- Pulmonary arterial hypertension10037454
- Registration Number
- NL-OMON34535
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
Inclusion Criteria
* Age18 years and above.
* IMPRES study fully completed or prematurely discontinued due to other reasons than related to QTI571 or safety.
Exclusion Criteria
* Pregnant or lactating females.
* Males and females of childbearing potential not using safe contraception method.
* Pulm wedge pressure >15 mmHg.
* LVEF <45%.
* Platelets < 50 x109/L.
* BP >160 mmHg (syst.) of >90 mmHg (diast.).
* QTcF >450 msec (males), c.q. 470 msec (females).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>6 minute walk test. Time to clinical deterioration. Medical resource<br /><br>utilization.</p><br>