Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Boehringer Ingelheim
Study ID
NCT01335464
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • placebo — DRUG
    placebo matching BIBF1120, BID
  • BIBF 1120 — DRUG
    BIBF1120 BID (twice daily)

Study Details

Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate. In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo. Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data. Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

Key Dates

Start date
Apr 30, 2011
Status verified
Jun 2016
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
515 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BIBF 1120
    patient receives capsules containing BIBF 1120 twice a day
  • Placebo Comparator: placebo
    patient receives capsules identical to those containing active drug

Primary Outcome Measure

Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks [ Time Frame: 52 weeks ]

Locations (24)

FacilityCityStateZIPSite coordinators
1199.32.10007 Boehringer Ingelheim Investigational SiteBirminghamAlabama--
1199.32.10029 Boehringer Ingelheim Investigational SiteJasperAlabama--
1199.32.10013 Boehringer Ingelheim Investigational SitePhoenixArizona--
1199.32.10005 Boehringer Ingelheim Investigational SiteLos AngelesCalifornia--
1199.32.10022 Boehringer Ingelheim Investigational SiteDanburyConnecticut--
1199.32.10025 Boehringer Ingelheim Investigational SiteNewarkDelaware--
1199.32.10023 Boehringer Ingelheim Investigational SiteWestonFlorida--
1199.32.10001 Boehringer Ingelheim Investigational SiteCouncil BluffsIowa--
1199.32.10028 Boehringer Ingelheim Investigational SiteWichitaKansas--
1199.32.10016 Boehringer Ingelheim Investigational SiteMinneapolisMinnesota--
1199.32.10024 Boehringer Ingelheim Investigational SiteNew BrunswichNew Jersey--
1199.32.10019 Boehringer Ingelheim Investigational SiteNew YorkNew York--
1199.32.10004 Boehringer Ingelheim Investigational SiteCincinnatiOhio--
1199.32.10020 Boehringer Ingelheim Investigational SitePortlandOregon--
1199.32.10002 Boehringer Ingelheim Investigational SitePittsburghPennsylvania--
1199.32.10033 Boehringer Ingelheim Investigational SitePittsburghPennsylvania--
1199.32.10008 Boehringer Ingelheim Investigational SiteProvidenceRhode Island--
1199.32.10015 Boehringer Ingelheim Investigational SiteNashvilleTennessee--
1199.32.10034 Boehringer Ingelheim Investigational SiteShelbyvilleTennessee--
1199.32.10009 Boehringer Ingelheim Investigational SiteDallasTexas--
1199.32.10018 Boehringer Ingelheim Investigational SiteMcKinneyTexas--
1199.32.10021 Boehringer Ingelheim Investigational SiteFalls ChurchVirginia--
1199.32.10003 Boehringer Ingelheim Investigational SiteLynchburgVirginia--
1199.32.10038 Boehringer Ingelheim Investigational SiteTacomaWashington--

Find similar trials in Birmingham, AL

By research site
1199.32.10007 Boehringer Ingelheim Investigational Site· Birmingham, AL1199.32.10029 Boehringer Ingelheim Investigational Site· Jasper, AL1199.32.10013 Boehringer Ingelheim Investigational Site· Phoenix, AZ1199.32.10005 Boehringer Ingelheim Investigational Site· Los Angeles, CA1199.32.10022 Boehringer Ingelheim Investigational Site· Danbury, CT1199.32.10025 Boehringer Ingelheim Investigational Site· Newark, DE

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