ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01346540
Recruitment Status : Completed
First Posted : May 3, 2011
Results First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: BIBF 1120
Drug: Placebo
Enrollment 16
Recruitment Details  
Pre-assignment Details Phase I was open-label, 3+3 dose-confirmation part of the trial aimed to confirm safety of nintedanib to a maximum dose of 200 milligram twice daily given in combination with the standard regimen of gemcitabine and cisplatin. Phase II was to be double-blind, randomised, placebo-controlled part, but this part of the trial was not conducted.
Arm/Group Title Nintedanib 150 Milligram Nintedanib 200 Milligram
Hide Arm/Group Description Patient received 150 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle. Patient received 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
Period Title: Overall Study
Started 4 12
Completed 1 0
Not Completed 3 12
Reason Not Completed
Progressive disease-RECIST 1.1 criteria             3             8
Adverse Event             0             4
Arm/Group Title Nintedanib 150 Milligram Nintedanib 200 Milligram Total
Hide Arm/Group Description Patient received 150 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle. Patient received 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle. Total of all reporting groups
Overall Number of Baseline Participants 4 12 16
Hide Baseline Analysis Population Description
All patients who received at least one dose of any study medication were included in the Treated Set (TS)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 12 participants 16 participants
64.5  (10.9) 65.7  (5.0) 65.4  (6.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 12 participants 16 participants
Female
0
   0.0%
1
   8.3%
1
   6.3%
Male
4
 100.0%
11
  91.7%
15
  93.8%
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs) During First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
Hide Description The following drug-related adverse events (AEs) qualified as a DLT: Non-hematological toxicity - Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3 events excluding transient electrolyte abnormality, hyperuricemia and isolated elevation of gamma-glutamyl trans-peptidase. Gastrointestinal AEs (nausea, vomiting, diarrhoea, abdominal pain) or hypertension of CTCAE Grade ≥3 despite optimal supportive care/intervention. Alanine aminotransferase and or Aspartate aminotransferase elevation of CTCAE Grade ≥3. Haematological toxicity - Uncomplicated CTCAE Grade 4 neutropenia (that was not associated with fever of ≥38.5° Celsius) for >7 days (except during Cycle 1). CTCAE Grade 4 febrile neutropenia associated with fever ≥38.5º Celsius. A decrease in platelet levels to CTCAE Grade 4 or CTCAE Grade 3 associated with bleeding or requiring transfusion. The inability to resume nintedanib dosing within 14 days of stopping due to a drug-related AE was also considered a DLT.
Time Frame Up to 21 days from first drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of nintedanib were included in the Safety Set.
Arm/Group Title Nintedanib 150 Milligram Nintedanib 200 Milligram
Hide Arm/Group Description:
Patient received 150 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
Patient received 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
Overall Number of Participants Analyzed 4 12
Measure Type: Number
Unit of Measure: Participants
0 0
2.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Nintedanib Added to Cisplatin/Gemcitabine Based on the Occurrence of DLTs During Treatment Cycle 1.
Hide Description The MTD was defined as the dose of nintedanib administered with gemcitabine/cisplatin at which no more than 1 of 6 patients experienced DLT (or one dose tier below that dose at which 2 or more of 6 patients experienced DLT) during the first 21-day treatment cycle. Any DLTs experienced after the start of the second treatment period were considered separately.
Time Frame Up to 21 days from first drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of nintedanib were included in the Safety Set.
Arm/Group Title Nintedanib 150/200 Milligram
Hide Arm/Group Description:
Patient received 150 or 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Milligram
200
3.Secondary Outcome
Title Incidence of Adverse Events (AEs) According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00
Hide Description Incidence of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00 with grade 1-5.
Time Frame From the first drug administration until 28 days after last study drug administration, up to 804 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set
Arm/Group Title Nintedanib 150 Milligram Nintedanib 200 Milligram
Hide Arm/Group Description:
Patient received 150 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
Patient received 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
Overall Number of Participants Analyzed 4 12
Measure Type: Number
Unit of Measure: Participants
Grade 1 0 0
Grade 2 0 0
Grade 3 1 8
Grade 4 3 2
Grade 5 0 2
Time Frame From the first drug administration until 28 days after last study drug administration, up to 804 days
Adverse Event Reporting Description Adverse events ongoing from the end of the treatment visit were also captured.
 
Arm/Group Title Nintedanib 150 Milligram Nintedanib 200 Milligram
Hide Arm/Group Description Patient received 150 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle. Patient received 200 milligram (mg) Nintedanib (BIBF 1120) soft gelatin capsules, administered orally twice daily until withdrawal criteria were fulfilled along with standard therapy of Gemcitabine and Cisplatin. Gemcitabine was administered as an intravenous infused dose of 1250 milligram per meter squared (mg/m2) on days 1 and 8 of each 21-day treatment cycle. Cisplatin was administered as an intravenous infused dose of 75 mg/m2 given on day 1 of each 21-day treatment cycle.
All-Cause Mortality
Nintedanib 150 Milligram Nintedanib 200 Milligram
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nintedanib 150 Milligram Nintedanib 200 Milligram
Affected / at Risk (%) Affected / at Risk (%)
Total   2/4 (50.00%)   5/12 (41.67%) 
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/4 (25.00%)  0/12 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  1/4 (25.00%)  0/12 (0.00%) 
Dysphagia  1  0/4 (0.00%)  1/12 (8.33%) 
Vomiting  1  0/4 (0.00%)  1/12 (8.33%) 
General disorders     
Fatigue  1  0/4 (0.00%)  1/12 (8.33%) 
Sudden death  1  0/4 (0.00%)  1/12 (8.33%) 
Infections and infestations     
Lower respiratory tract infection  1  1/4 (25.00%)  0/12 (0.00%) 
Pneumonia  1  0/4 (0.00%)  2/12 (16.67%) 
Respiratory tract infection  1  0/4 (0.00%)  1/12 (8.33%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/4 (0.00%)  1/12 (8.33%) 
Dehydration  1  0/4 (0.00%)  1/12 (8.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphangiosis carcinomatosa  1  0/4 (0.00%)  1/12 (8.33%) 
Renal and urinary disorders     
Renal failure  1  0/4 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/4 (0.00%)  2/12 (16.67%) 
Pneumonia aspiration  1  0/4 (0.00%)  1/12 (8.33%) 
Vascular disorders     
Deep vein thrombosis  1  0/4 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nintedanib 150 Milligram Nintedanib 200 Milligram
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   12/12 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  2/4 (50.00%)  3/12 (25.00%) 
Neutropenia  1  3/4 (75.00%)  4/12 (33.33%) 
Thrombocytopenia  1  3/4 (75.00%)  4/12 (33.33%) 
Cardiac disorders     
Atrial fibrillation  1  1/4 (25.00%)  0/12 (0.00%) 
Palpitations  1  1/4 (25.00%)  0/12 (0.00%) 
Ear and labyrinth disorders     
Deafness  1  1/4 (25.00%)  0/12 (0.00%) 
Ear discomfort  1  0/4 (0.00%)  1/12 (8.33%) 
Tinnitus  1  1/4 (25.00%)  3/12 (25.00%) 
Vertigo  1  0/4 (0.00%)  2/12 (16.67%) 
Eye disorders     
Blepharitis  1  1/4 (25.00%)  0/12 (0.00%) 
Lacrimation increased  1  1/4 (25.00%)  0/12 (0.00%) 
Visual acuity reduced  1  1/4 (25.00%)  0/12 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/4 (25.00%)  2/12 (16.67%) 
Abdominal pain upper  1  0/4 (0.00%)  1/12 (8.33%) 
Abdominal tenderness  1  1/4 (25.00%)  0/12 (0.00%) 
Constipation  1  1/4 (25.00%)  8/12 (66.67%) 
Diarrhoea  1  4/4 (100.00%)  5/12 (41.67%) 
Dyspepsia  1  2/4 (50.00%)  0/12 (0.00%) 
Gastrooesophageal reflux disease  1  1/4 (25.00%)  0/12 (0.00%) 
Gingival pain  1  1/4 (25.00%)  0/12 (0.00%) 
Haemorrhoidal haemorrhage  1  1/4 (25.00%)  0/12 (0.00%) 
Mouth haemorrhage  1  0/4 (0.00%)  1/12 (8.33%) 
Nausea  1  4/4 (100.00%)  9/12 (75.00%) 
Retching  1  1/4 (25.00%)  0/12 (0.00%) 
Stomatitis  1  1/4 (25.00%)  0/12 (0.00%) 
Toothache  1  1/4 (25.00%)  0/12 (0.00%) 
Vomiting  1  2/4 (50.00%)  8/12 (66.67%) 
General disorders     
Asthenia  1  1/4 (25.00%)  6/12 (50.00%) 
Chest discomfort  1  1/4 (25.00%)  0/12 (0.00%) 
Chest pain  1  1/4 (25.00%)  2/12 (16.67%) 
Fatigue  1  1/4 (25.00%)  3/12 (25.00%) 
Malaise  1  1/4 (25.00%)  0/12 (0.00%) 
Mucosal inflammation  1  1/4 (25.00%)  1/12 (8.33%) 
Non-cardiac chest pain  1  1/4 (25.00%)  0/12 (0.00%) 
Oedema  1  1/4 (25.00%)  0/12 (0.00%) 
Oedema peripheral  1  1/4 (25.00%)  1/12 (8.33%) 
Pyrexia  1  0/4 (0.00%)  3/12 (25.00%) 
Infections and infestations     
Candida infection  1  0/4 (0.00%)  1/12 (8.33%) 
Ear infection  1  1/4 (25.00%)  0/12 (0.00%) 
Lower respiratory tract infection  1  1/4 (25.00%)  1/12 (8.33%) 
Oral candidiasis  1  1/4 (25.00%)  0/12 (0.00%) 
Oral herpes  1  1/4 (25.00%)  0/12 (0.00%) 
Respiratory tract infection  1  0/4 (0.00%)  1/12 (8.33%) 
Rhinitis  1  1/4 (25.00%)  0/12 (0.00%) 
Skin infection  1  1/4 (25.00%)  0/12 (0.00%) 
Upper respiratory tract infection  1  1/4 (25.00%)  0/12 (0.00%) 
Urinary tract infection  1  0/4 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications     
Tooth fracture  1  1/4 (25.00%)  0/12 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/4 (25.00%)  1/12 (8.33%) 
Aspartate aminotransferase increased  1  1/4 (25.00%)  2/12 (16.67%) 
Blood albumin decreased  1  0/4 (0.00%)  1/12 (8.33%) 
Blood creatinine increased  1  0/4 (0.00%)  3/12 (25.00%) 
Blood lactate dehydrogenase increased  1  0/4 (0.00%)  1/12 (8.33%) 
Blood magnesium decreased  1  0/4 (0.00%)  1/12 (8.33%) 
Blood potassium decreased  1  1/4 (25.00%)  1/12 (8.33%) 
Blood sodium decreased  1  0/4 (0.00%)  1/12 (8.33%) 
Blood urea increased  1  0/4 (0.00%)  2/12 (16.67%) 
Blood uric acid increased  1  0/4 (0.00%)  2/12 (16.67%) 
Electrocardiogram QT prolonged  1  1/4 (25.00%)  0/12 (0.00%) 
Gamma-glutamyltransferase increased  1  0/4 (0.00%)  2/12 (16.67%) 
Haemoglobin decreased  1  0/4 (0.00%)  2/12 (16.67%) 
Monocyte count decreased  1  0/4 (0.00%)  1/12 (8.33%) 
Neutrophil count decreased  1  0/4 (0.00%)  2/12 (16.67%) 
Platelet count decreased  1  0/4 (0.00%)  2/12 (16.67%) 
Weight decreased  1  2/4 (50.00%)  4/12 (33.33%) 
White blood cell count decreased  1  0/4 (0.00%)  2/12 (16.67%) 
Metabolism and nutrition disorders     
Decreased appetite  1  4/4 (100.00%)  4/12 (33.33%) 
Dehydration  1  0/4 (0.00%)  1/12 (8.33%) 
Hyperuricaemia  1  0/4 (0.00%)  1/12 (8.33%) 
Hypokalaemia  1  0/4 (0.00%)  1/12 (8.33%) 
Hypomagnesaemia  1  0/4 (0.00%)  2/12 (16.67%) 
Hyponatraemia  1  0/4 (0.00%)  2/12 (16.67%) 
Increased appetite  1  1/4 (25.00%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/4 (25.00%)  2/12 (16.67%) 
Back pain  1  1/4 (25.00%)  0/12 (0.00%) 
Musculoskeletal pain  1  1/4 (25.00%)  2/12 (16.67%) 
Myalgia  1  1/4 (25.00%)  1/12 (8.33%) 
Neck pain  1  1/4 (25.00%)  1/12 (8.33%) 
Pain in extremity  1  0/4 (0.00%)  1/12 (8.33%) 
Periarthritis  1  1/4 (25.00%)  0/12 (0.00%) 
Sjogren's syndrome  1  1/4 (25.00%)  0/12 (0.00%) 
Nervous system disorders     
Dizziness  1  2/4 (50.00%)  1/12 (8.33%) 
Dizziness postural  1  0/4 (0.00%)  1/12 (8.33%) 
Dysgeusia  1  1/4 (25.00%)  1/12 (8.33%) 
Headache  1  2/4 (50.00%)  1/12 (8.33%) 
Lethargy  1  1/4 (25.00%)  0/12 (0.00%) 
Neuralgia  1  0/4 (0.00%)  1/12 (8.33%) 
Neuropathy peripheral  1  0/4 (0.00%)  1/12 (8.33%) 
Paraesthesia  1  1/4 (25.00%)  0/12 (0.00%) 
Peripheral sensory neuropathy  1  1/4 (25.00%)  3/12 (25.00%) 
Psychiatric disorders     
Anxiety  1  0/4 (0.00%)  1/12 (8.33%) 
Depressed mood  1  1/4 (25.00%)  0/12 (0.00%) 
Hallucination  1  0/4 (0.00%)  1/12 (8.33%) 
Insomnia  1  1/4 (25.00%)  4/12 (33.33%) 
Renal and urinary disorders     
Azotaemia  1  0/4 (0.00%)  1/12 (8.33%) 
Lower urinary tract symptoms  1  0/4 (0.00%)  2/12 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/4 (50.00%)  4/12 (33.33%) 
Dry throat  1  1/4 (25.00%)  0/12 (0.00%) 
Dysphonia  1  1/4 (25.00%)  0/12 (0.00%) 
Dyspnoea  1  3/4 (75.00%)  3/12 (25.00%) 
Dyspnoea exertional  1  1/4 (25.00%)  0/12 (0.00%) 
Epistaxis  1  2/4 (50.00%)  0/12 (0.00%) 
Haemoptysis  1  1/4 (25.00%)  2/12 (16.67%) 
Hiccups  1  1/4 (25.00%)  0/12 (0.00%) 
Nasal congestion  1  1/4 (25.00%)  0/12 (0.00%) 
Productive cough  1  0/4 (0.00%)  1/12 (8.33%) 
Rhinorrhoea  1  1/4 (25.00%)  1/12 (8.33%) 
Sputum increased  1  1/4 (25.00%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  1/4 (25.00%)  4/12 (33.33%) 
Dry skin  1  1/4 (25.00%)  0/12 (0.00%) 
Eczema  1  1/4 (25.00%)  0/12 (0.00%) 
Erythema  1  1/4 (25.00%)  0/12 (0.00%) 
Hyperhidrosis  1  0/4 (0.00%)  1/12 (8.33%) 
Pruritus  1  2/4 (50.00%)  1/12 (8.33%) 
Rash  1  2/4 (50.00%)  3/12 (25.00%) 
Rash maculo-papular  1  1/4 (25.00%)  0/12 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  0/4 (0.00%)  1/12 (8.33%) 
Haemorrhage  1  1/4 (25.00%)  0/12 (0.00%) 
Hot flush  1  1/4 (25.00%)  0/12 (0.00%) 
Hypertension  1  0/4 (0.00%)  4/12 (33.33%) 
Hypotension  1  0/4 (0.00%)  1/12 (8.33%) 
Phlebitis  1  0/4 (0.00%)  2/12 (16.67%) 
Thrombosis  1  0/4 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
This trial was prematurely discontinued (Phase II was not conducted) following Sponsor’s decision not to continue the trial in this indication.
Certain Agreements
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
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01346540     History of Changes
Other Study ID Numbers: 1199.82
2010-019707-32 ( EudraCT Number: EudraCT )
First Submitted: April 19, 2011
First Posted: May 3, 2011
Results First Submitted: November 23, 2017
Results First Posted: September 10, 2018
Last Update Posted: September 10, 2018