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Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

NCT00514683 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2015-01-06

Study results available
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Summary

The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis.

The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).

As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

Conditions

Interventions

DRUG

low dose BIBF1120 once daily

low dose BIBF1120 once daily

DRUG

low dose BIBF 1120 twice daily

low dose BIBF 1120 twice daily

DRUG

intermediate dose BIBF 1120 twice daily

intermediate dose BIBF 1120 twice daily

DRUG

high dose BIBF 1120 twice daily

high dose BIBF 1120 twice daily

DRUG

placebo

placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-06-30

Countries

  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Mexico
  • Netherlands
  • Portugal
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00514683 on ClinicalTrials.gov