Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment

Completed · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.

Key facts

Study ID

NCT02802345

Run by

Boehringer Ingelheim

People needed

274

Starts

2016-06-30

Expected to finish

2018-04-13

Last updated by the study team

2019-01-11

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent consistent with International Conference on Harmonization-Good Clinical Practice and local laws, signed prior to any study procedures being performed (including any required washout);
• Male or female patients aged >= 40 years at visit 1;
• A clinical diagnosis of IPF within the last 6 years before visit 1, based upon the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American thoracic Association 2011 guideline [P11-07084];
• Combination of high-resolution computed tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with a diagnosis of IPF as assessed by the investigator based on a HRCT scan performed within 18 months of visit 1;
• Carbon Monoxide Diffusion Capacity (corrected for Hb) less or equal to 35% predicted of normal at visit 1.

You may not qualify if…

• Previous enrolment in this trial;
• Alanine Transaminase, Aspartate Transaminase > 1.5 fold upper limit of normal (ULN) at visit 1;
• Total bilirubin > 1.5 fold ULN at visit 1;
• Relevant airways obstruction (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity <0.7 at visit 1)
• History of myocardial infarction within 6 months of visit 1 or unstable angina within 1 month of visit 1
• Bleeding Risk:
• Known genetic predisposition to bleeding;
• Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin, etc.) or high dose antiplatelet therapy;
• History of haemorrhagic central nervous system (CNS) event within 12 months prior to visit 1;
• History of haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers and/or major injury or surgery within 3 months prior to visit 1;
• International normalised ratio (INR) > 2 at visit 1;
• Prothrombin time (PT) and activated partial thromboplastin time (aPTT) > 150% of institutional ULN at visit 1;
• Planned major surgery during the trial participation, including lung transplantation, major abdominal or major intestinal surgery;
• History of thrombotic event (including stroke and transient ischemic attack) within 12 months of visit 1;
• Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault formula at visit 1;
• Presence of aortic stenosis (AS) per investigator judgement at visit 1;
• Severe chronic heart failure: defined by left ventricular ejection fraction (EF) < 25% per investigator judgement at visit 1;
• Presence of idiopathic hypertrophic subaortic stenosis (IHSS) per investigator judgement at visit 1;
• Second-degree or third-degree atrioventricular (AV) block on electrocardiogram (ECG) per investigator judgement at visit 1;
• Hypotension (systolic blood pressure [SBP] < 100 mm Hg or diastolic blood pressure [DBP] < 50 mm Hg) (symptomatic orthostatic hypotension) at visit 1;
• Uncontrolled systemic hypertension (SBP > 180 mmHg; or DBP > 100 mmHg) at visit 1;
• Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma, leukemia) that may predispose to priapism;
• Retinitis pigmentosa;
• History of vision loss;
• History of nonarteritic ischemic optic neuropathy;

Where it is running

• Pulmonary Assoc of Stamford — Stamford, Connecticut, United States
• University of Florida College of Medicine — Jacksonville, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Michigan Clinical Research Unit — Ann Arbor, Michigan, United States
• Minnesota Lung Center — Minneapolis, Minnesota, United States
• The Lung Research Center, LLC — Chesterfield, Missouri, United States
• NewYork-Presbyterian/Weill Cornell Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Clinical Research Solutions — Dayton, Ohio, United States
• Mercy Respiratory Specialist — Toledo, Ohio, United States
• The Oregon Clinic — Portland, Oregon, United States
• Lowcountry Lung and Crit Care — Charleston, South Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Pulmonary Associates of Richmond, Inc. — Richmond, Virginia, United States
• Royal Prince Alfred Hospital — Camperdown, Sydney, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim — Antwerp, Belgium
• ULB Hopital Erasme — Brussels, Belgium
• UZ Leuven — Leuven, Belgium
• University of Alberta Hospital (University of Alberta) — Edmonton, Alberta, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.