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.

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. - IMPRES Extension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34535

Enrollment

Registered

2010-09-24

Start date

2010-12-07

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension

Interventions

Treatment with QTI571.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * Pregnant or lactating females. * Males and females of childbearing potential not using safe contraception method. * Pulm wedge pressure >15 mmHg. * LVEF 160 mmHg (syst.) of >90 mmHg (diast.). * QTcF >450 msec (males), c.q. 470 msec (females).

Design outcomes

Primary

Measure	Time frame
Adverse events.	—

Secondary

Measure	Time frame
6 minute walk test. Time to clinical deterioration. Medical resource utilization.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)