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NCT02802345 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
274
Enrollment target

NCT02802345: Completed Phase 3 study, sponsored by Boehringer Ingelheim.

NCT02802345 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 274 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02802345, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
274 participants
Enrollment target

Study Summary

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

Primary Outcome

The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. Scores range from 0 to 100, with higher scores indicating more limitations. The mean and standard error presented are actually adjusted mean for change from baseline and its standard

Interventions

  • DRUG Placebo
  • DRUG Sildenafil
  • DRUG Nintedanib

Trial Details

FieldValue
Enrollment Target 274 participants
Start Date 2016-06-30
Est. Completion 2018-04-13
Phase Phase 3
Boehringer Ingelheim

515 total trials

What the finished NCT02802345 record still lists

NCT02802345 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02802345 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02802345 about?

NCT02802345 is a clinical study titled "Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment". To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.

What is the current status of trial NCT02802345?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2016-06-30. Estimated completion is 2018-04-13.

What interventions are being tested in trial NCT02802345?

The interventions under investigation include: Placebo (DRUG), Sildenafil (DRUG), Nintedanib (DRUG).

Who is sponsoring clinical trial NCT02802345?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02802345's enrollment target sits among peer trials

274 1207th of 2000 higher than 788 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02802345, the US trial registry maintained by the National Library of Medicine. NCT02802345 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.