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Tyrosine Kinase Inhibitor
Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment
Phase 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 24
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions
Summary
To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.
Eligible Conditions
- Idiopathic Pulmonary Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12
Secondary study objectives
Change From Baseline in Dyspnoea Using UCSD SOBQ at Week 24
Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12
Change From Baseline in SGRQ Total Score at Week 24
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nintedanib + placebo matching sildenafilExperimental Treatment2 Interventions
Group II: Nintedanib + SildenafilActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Nintedanib
FDA approved
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,554 Previous Clinical Trials
15,897,020 Total Patients Enrolled
52 Trials studying Idiopathic Pulmonary Fibrosis
47,667 Patients Enrolled for Idiopathic Pulmonary Fibrosis