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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: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00902174
Date of registration: 13/05/2009
Prospective Registration: Yes
Primary sponsor: Novartis Pharmaceuticals
Public title: Imatinib (QTI571) in Pulmonary Arterial Hypertension IMPRES
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)
Date of first enrolment: September 2009
Target sample size: 202
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00902174
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Austria Belgium Canada France Germany Italy Japan Korea, Republic of
Netherlands Spain Sweden Switzerland United Kingdom United States
Contacts
Name:     Novartis Pharmaceuticals
Address: 
Telephone:
Email:
Affiliation:  Novartis Pharmaceuticals
Key inclusion & exclusion criteria

Key Inclusion criteria

- Male or female patients =18 years of age with a current diagnosis of pulmonary
arterial hypertension (PAH) according to the Dana Point 2008 Meeting: World Health
Organization (WHO) Diagnostic Group I, idiopathic or heritable (familial or sporadic)
PAH, PAH associated with collagen vascular disease including systemic sclerosis,
rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. PAH
following one year repair of congenital heart defect [Atrial Septal Defect (ASD),
Ventricular Septal Defect (VSD) or Posterior Descending Artery (PDA)], or PAH
associated with diet therapies or other drugs

- A Pulmonary Vascular Resistance (PVR) = 800 dynes.sec.cm-5 (as assessed by Right Heart
Catheterization (RHC) at screening or in the 3 months preceding the screening visit)
despite treatment with two or more specific PAH therapies, including Endothelin
Receptor Antagonists (ERAs), phosphodiesterase 5 inhibitors (PDE5), or subcutaneous,
inhaled, intravenous or oral prostacyclin analogues for = 3 months. Background therapy
doses were to be stable for = 30 days except for warfarin and prostacyclin analogues (
= 30 days but doses could vary even within the month before enrollment).

- World Health Organization functional Class II-IV. For WHO Functional Class IV, one of
the 2 or more specific PAH therapies were to be an inhaled, subcutaneous, intravenous
or oral prostacyclin analogue, unless the subject showed intolerance of prostacyclin
analogues.

- 6MWD = 150 meters and = 450 meters at screening. Distances of two consecutive 6MWTs
were to be within 15% of one another.

Key Exclusion criteria

- With a pulmonary capillary wedge pressure > 15 mm Hg to rule out PAH secondary to left
ventricular dysfunction.

- With a diagnosis of pulmonary artery or vein stenosis

- Left ventricular ejection fraction (LVEF) < 45%

- With Disseminated Intravascular Coagulation (DIC)

- With evidence of major bleeding or intracranial hemorrhage

- With a history of elevated intracranial pressure

- With a history of latent bleeding risk such as diabetic retinopathy, gastrointestinal
bleeding due to gastric or duodenal ulcers, or colitis ulcerosa

- With a QTcF > 450 msec for males and > 470 msec for females at screening and baseline
in the absence of right bundle branch block.

- With a history of ventricular tachycardia, ventricular fibrillation or ventricular
flutter

- With a history of Torsades de Pointes

- With a history of long QT syndrome

- Having undergone atrial septostomy in the 3 months prior to the screening visit



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Pulmonary Arterial Hypertension
Intervention(s)
Drug: imatinib mesylate
Drug: Placebo
Primary Outcome(s)
Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks [Time Frame: 24 weeks]
Secondary Outcome(s)
Change From Baseline in Cardiac Output [Time Frame: 24 weeks]
Change From Baseline in Diastolic Arterial Blood Pressure [Time Frame: baseline and week 24]
Change From Baseline in Heart Rate [Time Frame: 24 weeks]
Change From Baseline in Mean Pulmonary Arterial Pressure [Time Frame: baseline and week 24]
Change From Baseline in Mean Pulmonary Capillary Wedge Pressure [Time Frame: baseline and week 24]
Change From Baseline in Pulmonary Resistance Index [Time Frame: baseline and week 24]
Change From Baseline in Pulmonary Vascular Resistance [Time Frame: baseline and week 24]
Change From Baseline in Right Atrial Pressure [Time Frame: baseline and week 24]
Change From Baseline in Systemic Vascular Resistance [Time Frame: baseline and week 24]
Change From Baseline in Systolic Arterial Blood Pressure [Time Frame: baseline and week 24]
Change in Borg Dyspnea Score During 6-minute Walk Test [Time Frame: week 24]
Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases [Time Frame: 24 weeks]
Covariance of End of Study CAMPHOR Score [Time Frame: Week 24]
Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant [Time Frame: predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168]
Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant [Time Frame: predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168]
Secondary ID(s)
CQTI571A2301
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 16/07/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00902174
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