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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002123-25 | EudraCT Number |
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The main objective of the current trial is to investigate safety, tolerability, pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4 weeks in patients with COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1026706 low dose | Experimental |
| |
| BI 1026706 medium | Experimental |
| |
| BI 1026706 high dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1026706 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period. | Safety and tolerability of BI 1026706, as assessed by frequency (in percent) of patients with treatment-emergent adverse events (TEAEs) over the treatment period. | From first drug administration until 4 days after last drug administration, up to 32 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Absolute Number of Neutrophil in Sputum at the End of the Planned Treatment Period | Change in Absolute Number of Neutrophil in Sputum at the end of the planned treatment period | 28 days |
| Maximum Measured Concentration of BI 1026706 in Plasma (Cmax) After the First Dose (Morning of Day 1) |
Not provided
Inclusion criteria:
Exclusion criteria:
Significant pulmonary disease other than COPD or other medical conditions as determined by medical history, examination, and clinical investigations at screening that may, in the opinion of the investigator, result in the any of the following:
Patients with current asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
Patients with clinically relevant abnormal hematology, blood chemistry, or urinalysis at the screening visit (Visit 1), if the abnormality indicates a relevant disease as defined in exclusion criterion number 1. Safety laboratory screening evaluation (Visit 1) can be repeated a maximum of two times.
Patients with a history of myocardial infarction or apoplexy within 6 months of the screening visit (Visit 1) or between the screening visit (Visit 1) and randomization.
Patients with a history of and/or active life-threatening cardiac arrhythmia, as assessed by the investigator.
Patients with a marked baseline prolongation of QT/QTcB interval (such as repeated demonstration of a QTcB interval >450 ms), pulse/heart rate outside 50 to 90 bpm at Visit 1 (if confirmed by pulse rate measurement over 60 seconds), or any other relevant ECG finding.
Patients with a history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome).
Patients with known active tuberculosis.
Patients with clinically relevant bronchiectasis, as assessed by the investigator.
Patients with any respiratory infection (such as common cold, acute sinusitis, or similar illnesses) or COPD exacerbation within 6 weeks prior to the screening visit (Visit 1) or between the screening visit and randomization.
Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1).
Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last 5 years. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed to participate.
Patients with a history of and/or active significant alcohol or drug abuse as assessed by the investigator.
Patients who are being treated with non-permitted concomitant medication.
Patients who have taken an investigational drug within 4 weeks prior to Visit 1 or if screening occurs within six half-lives of intake of another investigational drug (whichever is greater).
Patients with surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication as assessed by the investigator.
Patients with veins unsuited for venipuncture (for instance, veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture) as assessed by the investigator.
Patients who are unable to comply with the dietary regimen.
Patients who have been previously randomized in this study.
Patients who have donated more than 100 mL blood in the 4 weeks prior to Visit 1 and between Visit 1 and Visit 3 or patients who have the intention to donate blood between Visit 3 and four weeks after the end of trial visit.
Patients who are pregnant or breastfeeding
Male patients who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the trial medication treatment has finished.
Patient is assessed as unsuitable for inclusion by the investigator; for instance, because he or she is not considered to comply with study requirements
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg og Frederiksberg Hospital | København NV | 2400 | Denmark | |||
| Odense University Hospital |
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered in to the trial if any of the specific entry criteria was violated.
Double dummy trial, 2 different type of medication were dispensed to the patient with the help of two different bottles: Bottle 1 - 5 mg OR 25 mg BI 1026706 tablets or placebo tablets matching 5 mg and 25 mg BI 1026706 tablets, Bottle 2 -100 mg tablets or Placebo tablets matching 100 mg BI 1026706 tablets.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Placebo | Drug | For blinding purposes |
|
Maximum measured concentration of BI 1026706 in plasma (Cmax) after the first dose (morning of Day 1) |
| -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax) After the First Dose (Morning of Day 1) | Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax) after the first dose (morning of Day 1) | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| Area Under the Concentration-time Curve of BI 1026706 in Plasma (AUC 0-12h) After the First Dose (Morning of Day 1) | Area under the concentration-time curve of BI 1026706 in plasma (AUC 0-12h) after the first dose (morning of Day 1) | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| Maximum Measured Concentration of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax, ss) After the Last Dose (Morning of Day 28) | Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau (Cmax, ss) after the last dose (morning of Day 28) | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax, ss) After the Last Dose (Morning of Day 28) | Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax, ss) after the last dose (morning of Day 28) | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| Area Under the Concentration-time Curve of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUC Tau, ss) After the Last Dose (Morning of Day 28) | Area under the concentration-time curve of BI 1026706 in plasma at steady state over a uniform dosing interval tau (AUC tau, ss) after the last dose (morning of Day 28) | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| Odense C |
| 5000 |
| Denmark |
| PAREXEL International GmbH | Berlin | 14050 | Germany |
| IKF Pneumologie GmbH & Co. KG | Frankfurt | 60596 | Germany |
| Inamed GmbH | Gauting | 82131 | Germany |
| Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH | Großhansdorf | 22927 | Germany |
| Fraunhofer ITEM | Hanover | 30625 | Germany |
| KLB Gesundheitsforschung Lübeck GmbH | Lübeck | 23552 | Germany |
| Skånes universitetssjukhus, Lund | Lund | 221 85 | Sweden |
| The Medicines Evaluation Unit | Manchester | M23 9QZ | United Kingdom |
| FG001 | 5 Milligram BI 1026706 | Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
| FG002 | 25 Milligram BI 1026706 | Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
| FG003 | 100 Milligram BI 1026706 | Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
| COMPLETED |
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| NOT COMPLETED |
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Randomized set (RS): The RS included all patients who were randomized, whether treated or not. The treatment assignment was determined based on the treatment arm to which the patient was randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening. |
| BG001 | 5 Milligram BI 1026706 | Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
| BG002 | 25 Milligram BI 1026706 | Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
| BG003 | 100 Milligram BI 1026706 | Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period. | Safety and tolerability of BI 1026706, as assessed by frequency (in percent) of patients with treatment-emergent adverse events (TEAEs) over the treatment period. | Treated set (TS): The TS included all patients who were randomized and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patient received. | Posted | Number | Percentage of Patients | From first drug administration until 4 days after last drug administration, up to 32 days |
|
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| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Absolute Number of Neutrophil in Sputum at the End of the Planned Treatment Period | Change in Absolute Number of Neutrophil in Sputum at the end of the planned treatment period | Treated set including participants with available data for the endpoint percent change in absolute number of neutrophil in sputum at the end of the planned treatment period | Posted | Mean | Standard Error | 10^6 cells/ milliliter (mL) | 28 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Measured Concentration of BI 1026706 in Plasma (Cmax) After the First Dose (Morning of Day 1) | Maximum measured concentration of BI 1026706 in plasma (Cmax) after the first dose (morning of Day 1) | Extensive pharmacokinetic set (ePKS): The ePKS included all patients in the PKS who signed the informed consent for participating in the extensive PK sub-study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles (nmol) / litre (L) | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax) After the First Dose (Morning of Day 1) | Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax) after the first dose (morning of Day 1) | ePKS | Posted | Median | Full Range | hour | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve of BI 1026706 in Plasma (AUC 0-12h) After the First Dose (Morning of Day 1) | Area under the concentration-time curve of BI 1026706 in plasma (AUC 0-12h) after the first dose (morning of Day 1) | ePKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles (nmol) * hour (h) / litre (L) | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Measured Concentration of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax, ss) After the Last Dose (Morning of Day 28) | Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau (Cmax, ss) after the last dose (morning of Day 28) | ePKS including participants with available data for this endpoint | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax, ss) After the Last Dose (Morning of Day 28) | Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax, ss) after the last dose (morning of Day 28) | ePKS including participants with available data for this endpoint | Posted | Median | Full Range | hour | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUC Tau, ss) After the Last Dose (Morning of Day 28) | Area under the concentration-time curve of BI 1026706 in plasma at steady state over a uniform dosing interval tau (AUC tau, ss) after the last dose (morning of Day 28) | ePKS including participants with available data for this endpoint | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration. |
|
From first drug administration until 4 days after last drug administration, up to 32 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening. | 0 | 30 | 16 | 30 | ||
| EG001 | 5 Milligram BI 1026706 | Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. | 1 | 30 | 12 | 30 | ||
| EG002 | 25 Milligram BI 1026706 | Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. | 2 | 30 | 13 | 30 | ||
| EG003 | 100 Milligram BI 1026706 | Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. | 0 | 30 | 10 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual field defect | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| OG002 | 25 Milligram BI 1026706 | Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
| OG003 | 100 Milligram BI 1026706 | Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
|
|
|
| OG002 | 100 Milligram BI 1026706 | Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
|
|
| 100 Milligram BI 1026706 |
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
|
|
| OG002 | 100 Milligram BI 1026706 | Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
|
|
| OG002 | 100 Milligram BI 1026706 | Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
|
|
| OG002 | 100 Milligram BI 1026706 | Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
|
|
| OG002 | 100 Milligram BI 1026706 | Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. |
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