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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:  NCT00477269
Date of registration: 22/05/2007
Prospective Registration: No
Primary sponsor: Novartis Pharmaceuticals
Public title: Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension
Scientific title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH)
Date of first enrolment: April 2006
Target sample size: 59
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00477269
Study type:  Interventional
Study design:   
Phase:  Phase 2/Phase 3
Countries of recruitment
Austria Germany United Kingdom United States
Contacts
Name:     Novartis
Address: 
Telephone:
Email:
Affiliation:  Investigative site
Name:     Novartis Pharmaceuticals
Address: 
Telephone:
Email:
Affiliation:  Novartis Pharmaceuticals
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of PAH of either primary (idiopathic), familial or secondary to systemic
sclerosis (excluding those with marked pulmonary fibrosis) according to World
Conference on Pulmonary Hypertension classification (Venice, 2003).

- Symptoms with a WHO class of II-IV

Exclusion Criteria:

- Use of unspecific phosphodiesterase inhibitors (for example, pentoxyfillin, enoximon,
milrinone or pimobendan) during the study

- Chronic inhaled nitric oxide therapy from start to study completion

- Treatment with catecholamines (for example, adrenalin, noradrenalin, dopamine),

- Pre-existing lung diseases, including parasitic diseases affecting lungs, asthma,
congenital abnormalities of the lungs, chest, and diaphragm.

- Pulmonary artery or valve stenosis; pulmonary venous hypertension; chronic
thromboembolic pulmonary hypertension

- Acute heart failure or chronic left sided heart failure; congenital or acquired
valvular or myocardial disease

- Severe (systemic) arterial hypertension (> 200 mmHg (systolic) or > 120 mmHg
(diastolic)) Other protocol-defined inclusion/exclusion criteria may apply



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)
Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods [Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)]
Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods [Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)]
Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods [Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)]
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core [Time Frame: 6 months]
Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension [Time Frame: 72 months]
Secondary Outcome(s)
Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Blood Gas Measurement - PaCO2 at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Blood Gas Measurement - PaO2 at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Blood Gas Measurement - pH at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Blood Gas Measurement - PvO2 at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Blood Gas Measurement - Venous Saturation at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Borg Score During the Six Minutes Walk Test at Different Time Periods [Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)]
Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods [Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)]
Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods [Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)]
Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods [Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)]
Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods [Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)]
Mean Cardiac Output (CO) at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Mean Heart Rate (HR) at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion [Time Frame: Baseline, and Study completion (Week 24)]
Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity [Time Frame: Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion]
Secondary ID(s)
2005-005569-12
CSTI571E2203
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 23/03/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00477269
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