Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
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ClinicalTrials.gov Identifier: NCT01170065 |
Recruitment Status :
Completed
First Posted : July 27, 2010
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Pulmonary Fibrosis |
Intervention |
Drug: BIBF 1120 |
Enrollment | 198 |
Participant Flow
Recruitment Details | Treatment groups are displayed according to dose at randomisation in 1199.30 (NCT00514683). |
Pre-assignment Details | Patients were not randomised to study medication in trial 1199.35 but were to receive open-label nintedanib, either at the dose received in period 2 of parent trial 1199.30 (NCT00514683) or they could increase their dose to nintedanib 150 mg twice daily (bid) after implementation of protocol amendment 1. |
Arm/Group Title | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg |
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Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid) | Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid. | Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial. |
Period Title: Overall Study | |||
Started | 37 | 126 | 35 |
Completed | 9 [1] | 34 [1] | 9 [1] |
Not Completed | 28 | 92 | 26 |
Reason Not Completed | |||
Adverse Event | 17 | 50 | 10 |
Lost to Follow-up | 1 | 4 | 1 |
Consent withdrawn, not due to AE | 2 | 4 | 2 |
Reason other than specified | 3 | 8 | 3 |
Ongoing after planned observation time | 5 | 26 | 10 |
[1]
Planned observation time is from first trial drug intake to follow-up visit
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Baseline Characteristics
Arm/Group Title | Placebo | Nintedanib 50 mg- 100 mg | Nintedanib 150 mg | Total | |
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Patients were treated with oral administration of placebo in period 1 of the parent trial and with soft gelatine capsules of Nintedanib 50 mg once daily (qd) in the second period of the 1199.30 (parent trial). In the 1199.35 trial they could remain on this last dose or increase to Nintedanib 150 mg twice daily (bid) | Patients were treated with oral administration of soft gelatine capsules of Nintedanib 50 mg qd, 50 mg bid or 100 mg bid in the parent trial. In the 1199.35 trial they could remain on their last dose in the parent trial or increase to Nintedanib 150 mg bid. | Patients were treated with oral administration of soft gelatine capsules of Nintedanib 150 mg bid and could step down to 100 mg bid. In the 1199.35 trial they could remain on their last dose in the parent trial. | Total of all reporting groups | |
Overall Number of Baseline Participants | 37 | 126 | 35 | 198 | |
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Treated set (TS): The treated set which included all patients who received at least 1 dose of open-label study medication in trial 1199.35
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 37 participants | 126 participants | 35 participants | 198 participants | |
64.2 (7.3) | 65.4 (8.6) | 65.2 (7.2) | 65.2 (8.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 37 participants | 126 participants | 35 participants | 198 participants | |
Female |
14 37.8%
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36 28.6%
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7 20.0%
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57 28.8%
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Male |
23 62.2%
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90 71.4%
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28 80.0%
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141 71.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Name/Title: | Boehringer Ingelheim Call Center |
Organization: | Boehringer Ingelheim |
Phone: | 1-800-243-0127 |
EMail: | clintriage.rdg@boehringer-ingelheim.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01170065 |
Other Study ID Numbers: |
1199.35 2009-013788-21 ( EudraCT Number ) |
First Submitted: | July 6, 2010 |
First Posted: | July 27, 2010 |
Results First Submitted: | September 25, 2017 |
Results First Posted: | June 6, 2019 |
Last Update Posted: | June 6, 2019 |