Clinical trials: sponsored by Boehringer Ingelheim
Obesity
A Study to Test Different Doses of BI 456906 in Patients With Obesity
Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.
- Trial name
- NCT03591718
- Testing
- BI 456906
- Where
- 2 sites in Germany
- Volunteers
- 131 people
- Sponsor
- Boehringer Ingelheim
Neuroectodermal Tumors, Rhabdomyosarcoma
Trial of Afatinib in Pediatric Tumours
Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part. The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2.
- Trial name
- NCT02372006
- Testing
- afatinib
- Where
- 28 sites in United States, Australia and 10 more
- Volunteers
- 56 people
- Sponsor
- Boehringer Ingelheim
Pulmonary Disease, Chronic Obstructive
Re-usable Respimat® Soft MistTM Inhaler Study
The study is to assess patient satisfaction with the inhaler attributes of the re-usable Respimat SMI (Spiriva, Striverdi or Spiolto) in patients with COPD, including patients who are Respimat SMI-experienced and Respimat…
- Trial name
- NCT04011735
- Testing
- Respimat
- Where
- 20 sites in Belgium, Denmark and 4 more
- Volunteers
- 262 people
- Sponsor
- Boehringer Ingelheim
Schizophrenia
Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia
The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic…
- Trial name
- NCT02832037
- Testing
- BI 425809 dose 1, BI 425809 dose 2, BI 425809 dose 3
- Where
- 81 sites in United States, Austria and 9 more
- Volunteers
- 509 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung
GIOTRIF rPMS in Korean Patients With NSCLC
To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Trial name
- NCT02285361
- Testing
- GIOTRIF 20mg, GIOTRIF 40mg, GIOTRIF 30mg
- Where
- South Korea
- Volunteers
- 1,272 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung
Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung
The main objective is to assess the efficacy of afatinib in combination with pembrolizumab, as measured by objective response (OR) in patients with locally advanced or metastatic squamous NSCLC who progressed during or after…
- Trial name
- LUX-Lung-IO (NCT03157089)
- Testing
- Afatinib, pembrolizumab
- Where
- 13 sites in United States, France and 3 more
- Volunteers
- 24 people
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men and Women to Test Which Effects Donepezil and BI 425809 Have on Each Other
The main objective of Part 1of this trial is to investigate the effect of co-administration of multiple doses of donepezil on the single-dose pharmacokinetics of BI 425809 in healthy subjects.
- Trial name
- NCT03905096
- Testing
- BI 425809, Donepezil
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Parkinson Disease
The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa
The main objective of the study is to explore firstly, then further evaluate and confirm the efficacy between Pramipexole Sustained Release (SR) versus Pramipexole Immediate Release (IR) on nocturnal symptoms (as measured by the…
- Trial name
- NCT03521635
- Testing
- Pramipexole SR, Pramipexole IR
- Where
- 12 sites in China
- Volunteers
- 98 people
- Sponsor
- Boehringer Ingelheim
Stroke, Atrial Fibrillation
GLORIA-AF Registry Program (Phase II/III)
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events.
- Trial name
- NCT01937377
- Where
- 5 sites in Switzerland
- Volunteers
- 200 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung
Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.
- Trial name
- NCT02668393
- Testing
- Docetaxel, Nintedanib
- Where
- 4 sites in France, Germany
- Volunteers
- 14 people
- Sponsor
- Boehringer Ingelheim
Healthy
A Study to Test How Different Doses of BI 456906 Are Tolerated in Japanese Men With a Body Mass Index (BMI) Between 23 and 40 kg/m2
Main objectives are to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of different dose escalation schemes of BI 456906 in healthy Japanese male subject with BMI 23-40 kg/m2 and to determine a dose…
- Trial name
- NCT04384081
- Testing
- BI 456906
- Where
- Japan
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Stroke, Atrial Fibrillation
GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events.
- Trial name
- NCT01671007
- Where
- 522 sites in Austria, Belgium and 20 more
- Volunteers
- 10,471 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung
Afatinib Osimertinib Sequencing NIS
This is a non-interventional, multi-country, multi-centre cohort study based on existing data from medical records of patients with EGFR mutation-positive advanced NSCLC treated with afatinib (Gi(l)otrif®) as the first-line…
- Trial name
- NCT03370770
- Testing
- Afatinib, Osimertinib
- Where
- Austria
- Volunteers
- 204 people
- Sponsor
- Boehringer Ingelheim
Myelodysplastic Syndromes
Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes…
- Trial name
- NCT02240706
- Testing
- Best Supportive Care, BI 836858
- Where
- 5 sites in United States, Germany
- Volunteers
- 27 people
- Sponsor
- Boehringer Ingelheim
Heart Failure
This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms.
The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test (6MWT) in patients with chronic heart failure (CHF) with preserved ejection…
- Trial name
- NCT03448406
- Testing
- Empagliflozin
- Where
- 108 sites in United States, Australia and 9 more
- Volunteers
- 315 people
- Sponsor
- Boehringer Ingelheim
Heart Failure
This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms
The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test in patients with chronic HF with reduced ejection fraction (LVEF ≤ 40%) Secondary…
- Trial name
- NCT03448419
- Testing
- Empagliflozin
- Where
- 109 sites in United States, Australia and 9 more
- Volunteers
- 312 people
- Sponsor
- Boehringer Ingelheim
Pulmonary Disease, Chronic Obstructive
TARA Working Prototype [Version 2]: Feasibility Study
TARA is a Digital Behaviour Change Intervention (DBCI) for Individuals with COPD (IwCOPD), which has been designed using a Human-Centred Design (HCD) methodology.
- Trial name
- NCT04320524
- Testing
- Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention
- Sponsor
- Boehringer Ingelheim
Urologic Neoplasms
Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy
The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 (Erythroblastic leukaemia viral oncogene homolog of the human…
- Trial name
- LUX-Bladder 1 (NCT02780687)
- Testing
- Afatinib
- Where
- 30 sites in France, Italy and 1 more
- Volunteers
- 42 people
- Sponsor
- Boehringer Ingelheim
Scleroderma, Systemic
A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
The main objective is to assess the potential influence of continuous intake of nintedanib on the systemic exposure of ethinylestradiol and levonorgestrel when administered in combination.
- Trial name
- NCT03675581
- Testing
- Microgynon, Nintedanib
- Where
- 10 sites in Belgium, France and 4 more
- Volunteers
- 17 people
- Sponsor
- Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study
Descriptive prospective non-interventional multicenter study based on newly collected data of Idiopathic Pulmonary Fibrosis patients followed-up for one year in secondary care settings (Pulmonology Services)
- Trial name
- NCT03386994
- Where
- 31 sites in Spain
- Volunteers
- 204 people
- Sponsor
- Boehringer Ingelheim
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