A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION.
- Conditions
- IPF PH10035597
- Registration Number
- NL-OMON43371
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- 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 intermediate or high probability 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 <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
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method