Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

Part of paid clinical trials in Jasper, Alabama.

Sponsor
Boehringer Ingelheim
Study ID
NCT01619085
Phase
PHASE3
Status
Completed

Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

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

Interventions

  • Nintedanib — DRUG
    Nintedanib twice a day

Study Details

The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.

Key Dates

First listed
Jun 14, 2012
Start date
Jun 6, 2012
Status verified
Feb 2022
Primary completion
Jul 5, 2017
Completion
Feb 1, 2021

Study Design

Enrollment
752 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All subjects
    patient to receive a capsule containing Nintedanib twice a day

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days. ]

Locations (37)

FacilityCityStateZIPSite coordinators
Jasper Summit Research, LLCJasperAlabama35501-
Pulmonary AssociatesPhoenixArizona85006-
University of CaliforniaLos AngelesCalifornia90095-1690-
University of CaliforniaSan FranciscoCalifornia94143-
Sansum ClinicSanta BarbaraCalifornia93105-
Stanford University Medical CenterStanfordCalifornia94305-
University of CaliforniaTorranceCalifornia90505-
Western Connecticut Medical GroupDanburyConnecticut06810-
Pulmonary Assoc of StamfordStamfordConnecticut06902-
Cleveland ClinicWestonFlorida33331-
Georgia Clinical ResearchAustellGeorgia30106-
University of ChicagoChicagoIllinois60637-
Via Christi Clinic, PAWichitaKansas67208-
Baptist Health LexingtonLexingtonKentucky40503-
Minnesota Lung CenterMinneapolisMinnesota55407-
The Lung Research Center, LLCChesterfieldMissouri63017-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Pulmonary and Critical Care AssociatesAlbanyNew York12205-
Jamaica Hospital Medical CenterJamaicaNew York11418-
New York Presbyterian HospitalNew YorkNew York10032-
University of CincinnatiCincinnatiOhio45267-0565-
ID Clinical Research, LTDToledoOhio43608-
The Oregon ClinicPortlandOregon97220-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Rhode Island HospitalProvidenceRhode Island02903-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Vanderbilt University Medical CenterNashvilleTennessee37232-5735-
FDC Seifer PLC PulmonaryShelbyvilleTennessee37160-
University of Texas Southwestern Medical CenterDallasTexas75235-8550-
DCOL Center for Clinical ResearchLongviewTexas75605-
Metroplex Pul and Sleep CtrMcKinneyTexas75069-1769-
Diagnostics Research GroupSan AntonioTexas78229-
Vermont Lung CenterColchesterVermont05446-
Inova Fairfax HospitalFalls ChurchVirginia22042-
Lynchburg Pulmonary AssociatesLynchburgVirginia24501-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Jasper, AL

By research site
Jasper Summit Research, LLC· Jasper, ALPulmonary Associates· Phoenix, AZUniversity of California· Los Angeles, CAUniversity of California· San Francisco, CASansum Clinic· Santa Barbara, CAStanford University Medical Center· Stanford, CA

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