Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022685-27 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate | Experimental | Patient dose dependent on screening CrCl levels and TT |
|
| warfarin | Active Comparator | warfarin doses to maintain INR levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| warfarin 1mg | Drug | comparator warfarin |
| |
| dabigatran etexilate intermediate dose |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1 | Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) . Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population. | Week 1 |
| Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2 | Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population. | Week 2 |
| Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4 | Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population. | Week 4 |
| Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12 | Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1 | Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. | Week 1 |
| Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.113.32003 Boehringer Ingelheim Investigational Site | Brussels | Belgium | ||||
| 1160.113.32007 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23991661 | Derived | Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, Van de Werf F; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. doi: 10.1056/NEJMoa1300615. Epub 2013 Aug 31. |
Not provided
Not provided
76 patients were not entered/randomized
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran Etexilate (DE) | Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily |
| FG001 | Warfarin | Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
active treatment (medium) |
|
| dabigatran etexilate low dose | Drug | active treatment (low) |
|
| warfarin 5mg | Drug | comparator warfarin |
|
| dabigatran etexilate high dose | Drug | active treatment (high) |
|
| warfarin 3mg | Drug | comparator warfarin |
|
| Week 12 |
Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. |
| Week 2 |
| Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4 | Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. | Week 4 |
| Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12 | Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group. | Week 12 |
| Brussels |
| Belgium |
| 1160.113.32002 Boehringer Ingelheim Investigational Site | Genk | Belgium |
| 1160.113.32005 Boehringer Ingelheim Investigational Site | Ghent | Belgium |
| 1160.113.32001 Boehringer Ingelheim Investigational Site | Leuven | Belgium |
| 1160.113.11002 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada |
| 1160.113.11006 Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba | Canada |
| 1160.113.11001 Boehringer Ingelheim Investigational Site | Saint John | New Brunswick | Canada |
| 1160.113.11009 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1160.113.11011 Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| 1160.113.11012 Boehringer Ingelheim Investigational Site | Newmarket | Ontario | Canada |
| 1160.113.11007 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1160.113.42002 Boehringer Ingelheim Investigational Site | Brno | Czechia |
| 1160.113.42005 Boehringer Ingelheim Investigational Site | Hradec Králové | Czechia |
| 1160.113.42003 Boehringer Ingelheim Investigational Site | Olomouc | Czechia |
| 1160.113.42004 Boehringer Ingelheim Investigational Site | Ostrava | Czechia |
| 1160.113.42001 Boehringer Ingelheim Investigational Site | Prague | Czechia |
| 1160.113.45001 Boehringer Ingelheim Investigational Site | Copenhagen | Denmark |
| 1160.113.45002 Boehringer Ingelheim Investigational Site | Odense C | Denmark |
| 1160.113.33004 Boehringer Ingelheim Investigational Site | Bron | France |
| 1160.113.33001 Boehringer Ingelheim Investigational Site | Paris | France |
| 1160.113.33002 Boehringer Ingelheim Investigational Site | Pessac | France |
| 1160.113.33003 Boehringer Ingelheim Investigational Site | Rennes | France |
| 1160.113.49001 Boehringer Ingelheim Investigational Site | Dresden | Germany |
| 1160.113.49002 Boehringer Ingelheim Investigational Site | Essen | Germany |
| 1160.113.49008 Boehringer Ingelheim Investigational Site | Frankfurt am Main | Germany |
| 1160.113.49004 Boehringer Ingelheim Investigational Site | Freiburg im Breisgau | Germany |
| 1160.113.49003 Boehringer Ingelheim Investigational Site | Heidelberg | Germany |
| 1160.113.49010 Boehringer Ingelheim Investigational Site | Witten | Germany |
| 1160.113.31001 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands |
| 1160.113.31002 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands |
| 1160.113.31004 Boehringer Ingelheim Investigational Site | Breda | Netherlands |
| 1160.113.47002 Boehringer Ingelheim Investigational Site | Bergen | Norway |
| 1160.113.47001 Boehringer Ingelheim Investigational Site | Oslo | Norway |
| 1160.113.48004 Boehringer Ingelheim Investigational Site | Gdansk | Poland |
| 1160.113.48003 Boehringer Ingelheim Investigational Site | Warsaw | Poland |
| 1160.113.48001 Boehringer Ingelheim Investigational Site | Wroclaw | Poland |
| 1160.113.46004 Sahlgrenska Universitetssjukhuset | Gothenburg | Sweden |
| 1160.113.46003 Skånes Universitetssjukhus Lund | Lund | Sweden |
| 1160.113.46001 Akademiska Sjukhuset | Uppsala | Sweden |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TRT): The set of patients who received at least 1 dose of study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran Etexilate (DE) | Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily |
| BG001 | Warfarin | Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator |
| BG002 | 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 | Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1 | Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) . Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population. | Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Week 1 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2 | Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population. | Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Week 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4 | Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population. | Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12 | Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE). (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population. | Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1 | Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. | Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS. | Posted | Number | percentage of participants | Week 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2 | Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. | Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS. | Posted | Number | percentage of participants | Week 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4 | Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. | Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS. | Posted | Number | percentage of participants | Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12 | Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group. | Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS. | Posted | Number | percentage of participants | Week 12 |
|
|
From first intake of study drug until last intake of study drug plus 6 days (Up to 101 days).
There were 8 patients who switched from dabigatran etexilate to warfarin during the study, and hence these patients are counted in the denominator of both arms. Any AEs which occurred in these patients are only presented under the treatment that the patient was taking at the time of the event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran Etexilate | Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily | 19 | 162 | 64 | 162 | ||
| EG001 | Warfarin | Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator | 11 | 89 | 38 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection staphylococcal | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ventricular dysfunction | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Device malfunction | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| International normalised ratio decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
This study was terminated prematurely due to safety concerns arising during conduct of the trial.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014859 | Warfarin |
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
Not provided
Not provided
| Male |
|
| No |
| Superiority or Other |
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
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