A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.
- Conditions
- Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-005131-40-IT
- Lead Sponsor
- F. HOFFMANN - LA ROCHE LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 177
- Age 40-80 years (inclusive) at Screening
- Diagnosis of IPF for at least 3 months prior to screening
- Confirmation of IPF diagnosis by the Investigator, in accordance with the 2011 international consensus guidelines, at Screening
- Advanced IPF as defined by a measurable carbon monoxide diffusing capacity/pulmonary diffusing capacity [DLCO] <= 40% of predicted value at Screening and risk of Grade 3 PH (as defined in the protocol)
- Prior to the start of Screening, receiving pirfenidone for at least 12 weeks, and on a dose in the range of 1602 to 2403 mg/day for at least 4 weeks prior to the first Screening Visit.
- WHO Functional Class II or III at Screening
- 6MWD of 100 to 450 meters at Screening
- For women of childbearing potential: agreement to remain abstinent or use a non-hormonal contraceptive method with a failure rate of <1% per year during the treatment period and for at least 58 days after the last dose of study treatment
- For men who are not surgically sterile: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm for at least 118 days after the last dose of study treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132
- History of any of the following types of PH: Group 1 pulmonary arterial hypertension (PAH); Group 2 (left-heart disease); Group 3 (due to conditions other than interstitial lung disease; Group 4 (chronic thromboembolic pulmonary hypertension); Group 5 (other disorders)
- History of clinically significant cardiac disease in the opinion of the Investigator
- History of coexistent and clinically significant (in the opinion of the Investigator) COPD, bronchiectasis, asthma, inadequately treated sleep-disordered breathing, or any clinically significant pulmonary diseases or disorders other than IPF or PH secondary to IPF
- Hypotension, autonomic dysfunction, or conditions in which vasodilation may cause an unsafe drop in blood pressure (BP)
- History of use of drugs and toxins known to cause PAH
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method