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Imatinib (QTI571) in Pulmonary Arterial Hypertension

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: imatinib mesylate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH).

Clinical Details

Official 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)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks

Secondary outcome:

Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases

Change From Baseline in Right Atrial Pressure

Change From Baseline in Mean Pulmonary Arterial Pressure

Change From Baseline in Mean Pulmonary Capillary Wedge Pressure

Change From Baseline in Systemic Vascular Resistance

Change From Baseline in Pulmonary Vascular Resistance

Change From Baseline in Pulmonary Resistance Index

Change From Baseline in Cardiac Output

Change From Baseline in Systolic Arterial Blood Pressure

Change From Baseline in Diastolic Arterial Blood Pressure

Change From Baseline in Heart Rate

Change in Borg Dyspnea Score During 6-minute Walk Test

Covariance of End of Study CAMPHOR Score

Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant

Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Novartis investigative site, Innsbruck, Austria

Novartis Investigative Site, Vienna, Austria

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Novartis Investigative Site, Leuven, Belgium

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Additional Information

Starting date: September 2009
Last updated: June 12, 2013

Page last updated: August 23, 2015

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