Clinical trials: sponsored by Boehringer Ingelheim
Healthy
Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects
The primary objective of this trial is to investigate the relative bioavailability of five different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1, Formulation C1, Formulation D1, and Formulation E1…
- Trial name
- NCT02710630
- Testing
- Dabigatran etexilate tablet E1, Dabigatran etexilate tablet D1, Dabigatran etexilate tablet C1
- Where
- Japan
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Carcinoma, Hepatocellular
Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients
- Trial name
- NCT01004003
- Testing
- Sorafenib, BIBF 1120
- Where
- 28 sites in Austria, France and 6 more
- Volunteers
- 125 people
- Sponsor
- Boehringer Ingelheim
Schizophrenia
A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.
The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic…
- Trial name
- NCT02281773
- Testing
- BI 409306 100 mg QD, BI 498306 50 mg QD, BI 498306 25 mg QD
- Where
- 43 sites in United States, Canada and 3 more
- Volunteers
- 518 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung, ErbB Receptors
Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)
There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.
- Trial name
- NCT02695290
- Testing
- Afatinib
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Healthy
Safety Tolerability and Pharmacokinetic of BI 411034
The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.
- Trial name
- NCT01581684
- Testing
- BI 411034
- Where
- Germany
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Glioma
BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma
Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992 administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade III and IV).
- Trial name
- NCT00727506
- Testing
- BIBW 2992, TMZ, BIBW 2992 plus TMZ
- Where
- 28 sites in United States, Canada
- Volunteers
- 151 people
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 2
Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose…
- Trial name
- NCT01581658
- Testing
- BI10773
- Where
- Japan
- Volunteers
- 32 people
- Sponsor
- Boehringer Ingelheim
Abdominal Pain
Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort
In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or…
- Trial name
- NCT02242305
- Testing
- Hyoscine Butylbromide - Tablet, Hyoscine Butylbromide - Capsule
- Volunteers
- 302 people
- Sponsor
- Boehringer Ingelheim
Colorectal Neoplasms
Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)
The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.
- Trial name
- NCT02149108
- Testing
- Nintedanib (BIBF 1120), BSC
- Where
- 129 sites in United States, Argentina and 23 more
- Volunteers
- 768 people
- Sponsor
- Boehringer Ingelheim
Neoplasms
Trial of Afatinib (BIBW 2992) + Cetuximab in Advanced Solid Tumours
The trial is divided in two parts, Part A and Part B. Part A will involve dose-finding of dose-limiting toxicity (DLT) and MTD in patients with advanced solid tumours.
- Trial name
- NCT02020577
- Testing
- Cetuximab( erbitux®), Afatinib
- Where
- 2 sites in France, Spain
- Volunteers
- 58 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage
This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from Humana's health plan operations.
- Trial name
- NCT02061748
- Testing
- Observational
- Where
- United States
- Volunteers
- 38,499 people
- Sponsor
- Boehringer Ingelheim
Pulmonary Disease, Chronic Obstructive
Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy
The decrease in physical activity due to increasing dyspnoea that over time leads to a steadily worsening condition and increasing restriction of physical functioning is a key problem for COPD patients and affects even the early…
- Trial name
- NCT02173769
- Testing
- Spiriva® Respimat®, Striverdi® Respimat®
- Where
- 701 sites in Germany
- Volunteers
- 1,845 people
- Sponsor
- Boehringer Ingelheim
Healthy
Bioavailability of Different Applications of Dabigatran in Healthy Volunteers
To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution, both with 150 mg of dabigatran etexilate as…
- Trial name
- NCT02171611
- Testing
- Dabigatran etexilate pellets, Dabigatran etexilate powder, Dabigatran etexilate capsule
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 2, Healthy
Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls
Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus and healthy controls
- Trial name
- NCT01867307
- Testing
- Empagliflozin, BI 10773
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)
To provide early access and to evaluate the safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF).
- Trial name
- NCT02171156
- Testing
- nintedanib
- Where
- 7 sites in United States
- Sponsor
- Boehringer Ingelheim
Healthy
To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet
The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg caffeine against 400 mg ibuprofen alone under fed conditions
- Trial name
- NCT02629354
- Testing
- Ibuprofen, Caffeine
- Where
- South Africa
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Influence of Bosentan on the Pharmacokinetics of Nintedanib
The trial was designed to investigate whether, and to which extent, multiple doses of bosentan may influence the plasma levels of nintedanib administered as a single dose.
- Trial name
- NCT02667704
- Testing
- Bosentan, Nintedanib
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use
To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).
- Trial name
- NCT02129192
- Testing
- Amlodipine 5mg capsule, T80/H12.5 mg FDC tablet, T80/A5/H12.5 mg FDC tablet
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use
The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups.
- Trial name
- NCT02121535
- Testing
- T80/A5 mg FDC tablet, H12.5 mg tablet, T80/A5/H12.5 ng FDC tablet
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.
- Trial name
- NCT02516098
- Testing
- hyoscine butylbromide
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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