Phase 3 N=59 Randomized Double-blind Treatment

Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00477269 ↗

Enrolled (actual)

Serious AEs

48.2%

Results posted

Mar 2015

Primary outcome: Primary: Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core — 27; 29; 3; 3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Imatinib mesylate (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core	27; 29; 3; 3; 12; 11	—
PRIMARY Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension	22; 4; 16	—
PRIMARY Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods	10.2; 8.2; 17.0; 15.5; 21; 7.8	—
PRIMARY Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods	-0.2; 0.1; -0.2; 0.0; -0.3; 0.3	—
PRIMARY Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods	-0.06; 0.12; -0.03; 0.07; -0.03; 0.19	—
SECONDARY Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity	2; 1; 14; 22; 11; 7	—
SECONDARY Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods	94.3; 93.4; 87.9; 87.9; 93.0; 92.0	—
SECONDARY Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods	111.3; 104.6; 119.9; 118.3; 120.0; 110.4	—
SECONDARY Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods	68.2; 67.9; 75.1; 69.5; 71.6; 67.9	—
SECONDARY Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods	80.8; 87.9; 106.3; 112.3; 84.2; 94.1	—
SECONDARY Borg Score During the Six Minutes Walk Test at Different Time Periods	0.27; 0.43; 3.34; 3.02; 0.88; 1.08	—
SECONDARY Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion	61.7; 59.2; 61.6; 55.7; 58.1; 53.3	—
SECONDARY Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion	9.0; 7.6; 9.5; 7.7; 9.4; 7.8	—
SECONDARY Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion	110.3; 108.2; 108.3; 106.9; 109.9; 105.4	—
SECONDARY Mean Heart Rate (HR) at Baseline and Study Completion	77.3; 84.9; 75.9; 84.4; 75.2; 83.3	—
SECONDARY Mean Cardiac Output (CO) at Baseline and Study Completion	4.20; 4.09; 4.02; 4.22; 3.98; 4.43	—
SECONDARY Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion	1124.4; 1118.3; 1180.9; 1067.9; 1064.6; 982.8	—
SECONDARY Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion	1674.4; 1764.8; 1778.2; 1769.7; 1807.3; 1664.7	—
SECONDARY Blood Gas Measurement - PaO2 at Baseline and Study Completion	63.36; 63.75; 72.49; 70.13	—
SECONDARY Blood Gas Measurement - PaCO2 at Baseline and Study Completion	32.70; 30.02; 33.36; 30.23	—
SECONDARY Blood Gas Measurement - PvO2 at Baseline and Study Completion	33.16; 34.70; 35.56; 32.65	—
SECONDARY Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion	87.99; 91.81; 92.89; 91.78	—
SECONDARY Blood Gas Measurement - Venous Saturation at Baseline and Study Completion	57.96; 60.84; 65.11; 57.00	—
SECONDARY Blood Gas Measurement - pH at Baseline and Study Completion	7.43; 7.44; 7.44; 7.46	—

Summary

This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00477269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.