Status:
COMPLETED
Imatinib (QTI571) in Pulmonary Arterial Hypertension
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hyp...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00902174
Start Date
September 1 2009
End Date
May 1 2011
Last Update
February 17 2016
Active Locations (95)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Birmingham, Alabama, United States, 35294
2
Novartis Investigative Site
Phoenix, Arizona, United States, 85013
3
Novartis Investigative Site
Los Angeles, California, United States, 90024
4
Novartis Investigative Site
San Francisco, California, United States, 94143