Clinical trials: sponsored by Boehringer Ingelheim
Healthy
This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated
The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses.
- Trial name
- NCT03259464
- Testing
- BI 685509
- Where
- 2 sites in Japan, South Korea
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 2
Linagliptin as Add on to Basal Insulin in the Elderly
To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older…
- Trial name
- NCT02240680
- Testing
- linagliptin
- Where
- 145 sites in United States, Australia and 15 more
- Volunteers
- 302 people
- Sponsor
- Boehringer Ingelheim
Healthy
Pharmacokinetics and Safety in Healthy Volunteers
Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.
- Trial name
- NCT02045979
- Testing
- BI 695501, adalimumab-EU source, adalimumab-US source
- Where
- 3 sites in Belgium, New Zealand
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Safety and Tolerability of BI 685509 in Healthy Subjects
The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses.
- Trial name
- NCT03116906
- Testing
- BI 685509
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pulmonary Disease, Chronic Obstructive
Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in…
- Trial name
- NCT02296138
- Testing
- olodaterol, tiotropium
- Where
- 818 sites in United States, Argentina and 49 more
- Volunteers
- 7,903 people
- Sponsor
- Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg…
- Trial name
- NCT01979952
- Testing
- Nintedanib
- Where
- 25 sites in United States, Canada and 1 more
- Volunteers
- 113 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation.
- Trial name
- NCT00949650
- Testing
- Pemetrexed, BIBW 2992, Cisplatin
- Where
- 133 sites in United States, Argentina and 23 more
- Volunteers
- 345 people
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 1
Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus
To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin.
- Trial name
- NCT02702011
- Testing
- empagliflozin medium dose, empagliflozin low dose, empagliflozin high dose
- Where
- 4 sites in Japan
- Volunteers
- 48 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan
The primary objective of this study is to compare the Length of Stay from treatment of oral anticoagulant initiation to hospital discharge of patients hospitalized and subsequently treated with dabigatran or warfarin for…
- Trial name
- NCT02631057
- Testing
- Dabigatran, Warfarin
- Where
- 2 sites in Japan
- Volunteers
- 4,313 people
- Sponsor
- Boehringer Ingelheim
Hemorrhage
CU Programme of Idarucizumab for Japanese Patients
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when…
- Trial name
- NCT02831660
- Testing
- idarucizumab
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Head and Neck Neoplasms, Carcinoma, Squamous Cell
LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy
This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy.
- Trial name
- NCT01345682
- Testing
- Afatinib, Methotrexate
- Where
- 101 sites in United States, Argentina and 17 more
- Volunteers
- 483 people
- Sponsor
- Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF
This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone.
- Trial name
- NCT02579603
- Testing
- Nintedanib, Pirfenidone
- Where
- 23 sites in United States, Canada and 4 more
- Volunteers
- 105 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation
To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).
- Trial name
- NCT01491178
- Testing
- Prazaxa
- Where
- 1,164 sites in Japan
- Volunteers
- 6,772 people
- Sponsor
- Boehringer Ingelheim
Arthritis, Rheumatoid
Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to…
- Trial name
- NCT01682512
- Testing
- BI 695500, Rituxan®, MabThera®
- Where
- 110 sites in United States, Argentina and 15 more
- Volunteers
- 294 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF)…
- Trial name
- NCT02348723
- Testing
- Warfarin, Dabigatran Etexilate 150mg
- Where
- 87 sites in United States, Belgium and 9 more
- Volunteers
- 678 people
- Sponsor
- Boehringer Ingelheim
Arthritis, Rheumatoid
BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis
Primary Objective: The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a statistical comparison of the…
- Trial name
- NCT02137226
- Testing
- BI 695501, US-licensed Humira®
- Where
- 138 sites in United States, Bulgaria and 13 more
- Volunteers
- 645 people
- Sponsor
- Boehringer Ingelheim
Arthritis, Rheumatoid
Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis
The primary objective of this trial is to evaluate the long-term safety of BI 695500 in adult patients with moderately to severely active rheumatoid arthritis (RA) who have successfully completed treatment in Trial 1301.1.
- Trial name
- NCT01955733
- Testing
- BI 695500
- Where
- 43 sites in United States, Belgium and 7 more
- Volunteers
- 91 people
- Sponsor
- Boehringer Ingelheim
Leukemia, Lymphocytic, Chronic, B-Cell
This Study in Patients With Chronic Lymphocytic Leukaemia is Done to Determine a Safe and Effective Dose of BI 836826 in Combination With Venetoclax
The main objective of this trial is to determine the maximum tolerated dose (MTD) of BI 836826 in combination with venetoclax on the basis of dose limiting toxicities (DLTs incidence rate during the MTD evaluation period of the…
- Trial name
- NCT03343678
- Testing
- Venetoclax, BI 836826
- Sponsor
- Boehringer Ingelheim
Hemorrhage
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
- Trial name
- NCT02104947
- Testing
- idarucizumab
- Where
- 176 sites in United States, Argentina and 31 more
- Volunteers
- 503 people
- Sponsor
- Boehringer Ingelheim
Colorectal Neoplasms
A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer
The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with…
- Trial name
- NCT00801294
- Testing
- BIBF 1120 and BIBW 2992
- Where
- 24 sites in France
- Volunteers
- 46 people
- Sponsor
- Boehringer Ingelheim
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