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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 28 August 2012
Main ID:  EUCTR2009-012057-38-IT
Date of registration: 30/10/2009
Prospective Registration: Yes
Primary sponsor: NOVARTIS FARMA
Public 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) - ND
Scientific 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) - ND
Date of first enrolment: 06/11/2009
Target sample size: 200
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012057-38
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Austria Belgium France Germany Italy Netherlands Spain Sweden
United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
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

Exclusion criteria:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Pulmonary arterial hypertension,
MedDRA version: 9.1 Level: PT Classification code 10037400
Intervention(s)

Trade Name: GLIVEC
Pharmaceutical Form: Tablet
INN or Proposed INN: Imatinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: To evaluate the efficacy of QTI571 compared to placebo as measured by the change in 6- minute walk distance (6MWD) from baseline to 24-weeks
Primary end point(s): 6MWD - a marker of exercise tolerance (the distance walked in 6 minutes during a 6-minute walk test according to ATS guidelines)
Secondary Objective: To evaluate the time to clinical worsening (TTCW) To assess the safety and tolerability of QTI571. To evaluate change in pulmonary hemodynamics from baseline in patients after 24 weeks of treatment with QTI571 as compared to placebo. To assess change in Borg dyspnea score during 6-minute walk testing (6MWT), monthly, with QTI571 as compared to placebo. To assess the pharmacokinetics of QTI571 and the potential for interaction of QTI571 on sildenafil and bosentan.
Secondary Outcome(s)
Secondary ID(s)
2009-012057-38-DE
CQTI571A2301
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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