Japanese Pradaxa PMS, Long Term
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03175198
Collaborator
(none)
5,660
1
42.3
133.9
Study Details
Study Description
Brief Summary
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The study is Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Japanese patients with nonvalvular atrial fibrillation after the availability of idarucizumab. Even after the availability of idarucizumab in real clinical practice, appropriate use of Prazaxa® Capsules will continue. The patient population who receive Prazaxa® Capsules and the safety profile of Prazaxa® Capsules is not expected to change. This study investigates appropriate use with prospective investigation in the routine medical practice
Study Design
Study Type:
Observational
Actual Enrollment
:
5660 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-Marketing Surveillance on the Use of Prazaxa® Capsules in Japanese Patients With Nonvalvular Atrial Fibrillation After the Availability of Idarucizumab
Actual Study Start Date
:
Jul 5, 2017
Actual Primary Completion Date
:
Dec 21, 2020
Actual Study Completion Date
:
Jan 12, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with nonvalvular atrial fibrillation (NVAF) Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. |
Drug: Prazaxa® Capsules
Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) [From baseline till the last administration + 6 days. Up to 364 days.]
Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Percentages were pre-specified to be rounded to two decimal places.
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Male and female patients with nonvalvular atrial fibrillation who have never received Prazaxa® Capsules / dabigatran etexilate for preventing the occurrence of ischemic stroke and systemic embolism before enrolment in Japan
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nippon Boehringer Ingelheim Co., Ltd | Tokyo | Japan |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Rie Ikeda, 81364172200, zzCDMJP_PV_PMS@boehringer-ingelheim.com
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03175198
Other Study ID Numbers:
- 1160-0284
First Posted:
Jun 5, 2017
Last Update Posted:
Apr 6, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation. |
|---|---|
| Pre-assignment Detail | All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Out of the 5660 enrolled subjects case report forms (CRF) were collected for 5565 subjects. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety profile of Prazaxa® in a real-world setting and not to compare between different dose groups. |
| Arm/Group Title | Patients With Nonvalvular Atrial Fibrillation (NVAF) |
|---|---|
| Arm/Group Description | Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. |
| Period Title: Overall Study | |
| STARTED | 5565 |
| Safety Set 1 | 5436 |
| COMPLETED | 3238 |
| NOT COMPLETED | 2327 |
Baseline Characteristics
| Arm/Group Title | Patients With Nonvalvular Atrial Fibrillation (NVAF) |
|---|---|
| Arm/Group Description | Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. |
| Overall Participants | 5436 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
69.8
(11.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1624
29.9%
|
| Male |
3812
70.1%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
Outcome Measures
| Title | Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) |
|---|---|
| Description | Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Percentages were pre-specified to be rounded to two decimal places. |
| Time Frame | From baseline till the last administration + 6 days. Up to 364 days. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set 1: This patient set included all patients who were documented to take at least one dose of Prazasa® except patients who experienced with Prazaxa® treatment for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after the entry. |
| Arm/Group Title | Patients With Nonvalvular Atrial Fibrillation (NVAF) |
|---|---|
| Arm/Group Description | Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. |
| Measure Participants | 5436 |
| Number [Percentage of participants] |
10.69
0.2%
|
Adverse Events
| Time Frame | From baseline till the last administration + 6 days. Up to 364 days. | |
|---|---|---|
| Adverse Event Reporting Description | Safety Set 1: all patients who took at least one dose of Prazasa® except patients who were treated with Prazaxa® for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after entry. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety of Prazaxa® in a real-world setting and not comparing different dose groups. | |
| Arm/Group Title | Patients With Nonvalvular Atrial Fibrillation (NVAF) | |
| Arm/Group Description | Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg [as 2 capsules of 75 mg] twice a day (b.i.d)) or 220 mg (110 mg [as 1 capsule of 110 mg] b.i.d) for a treatment duration of 52 weeks. | |
All Cause Mortality |
||
| Patients With Nonvalvular Atrial Fibrillation (NVAF) | ||
| Affected / at Risk (%) | # Events | |
| Total | 51/5436 (0.9%) | |
Serious Adverse Events |
||
| Patients With Nonvalvular Atrial Fibrillation (NVAF) | ||
| Affected / at Risk (%) | # Events | |
| Total | 416/5436 (7.7%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 4/5436 (0.1%) | |
| Disseminated intravascular coagulation | 1/5436 (0%) | |
| Cardiac disorders | ||
| Cardiac failure | 64/5436 (1.2%) | |
| Atrial fibrillation | 28/5436 (0.5%) | |
| Cardiac failure congestive | 13/5436 (0.2%) | |
| Angina pectoris | 10/5436 (0.2%) | |
| Sinus node dysfunction | 8/5436 (0.1%) | |
| Acute myocardial infarction | 5/5436 (0.1%) | |
| Cardiac tamponade | 5/5436 (0.1%) | |
| Cardiac failure acute | 4/5436 (0.1%) | |
| Atrial thrombosis | 4/5436 (0.1%) | |
| Atrioventricular block complete | 3/5436 (0.1%) | |
| Cardiac failure chronic | 3/5436 (0.1%) | |
| Pericardial effusion | 3/5436 (0.1%) | |
| Aortic valve stenosis | 2/5436 (0%) | |
| Atrial flutter | 2/5436 (0%) | |
| Myocardial infarction | 2/5436 (0%) | |
| Pericardial haemorrhage | 2/5436 (0%) | |
| Ventricular tachycardia | 2/5436 (0%) | |
| Aortic valve incompetence | 1/5436 (0%) | |
| Arteriosclerosis coronary artery | 1/5436 (0%) | |
| Bundle branch block left | 1/5436 (0%) | |
| Cardiomegaly | 1/5436 (0%) | |
| Coronary artery stenosis | 1/5436 (0%) | |
| Mitral valve incompetence | 1/5436 (0%) | |
| Sinus arrest | 1/5436 (0%) | |
| Supraventricular tachycardia | 1/5436 (0%) | |
| Tachycardia paroxysmal | 1/5436 (0%) | |
| Ventricular fibrillation | 1/5436 (0%) | |
| Stress cardiomyopathy | 1/5436 (0%) | |
| Ear and labyrinth disorders | ||
| Vertigo | 1/5436 (0%) | |
| Endocrine disorders | ||
| Basedow's disease | 1/5436 (0%) | |
| Eye disorders | ||
| Glaucoma | 2/5436 (0%) | |
| Cataract | 1/5436 (0%) | |
| Gastrointestinal disorders | ||
| Gastrointestinal haemorrhage | 6/5436 (0.1%) | |
| Melaena | 4/5436 (0.1%) | |
| Diverticulum intestinal haemorrhagic | 3/5436 (0.1%) | |
| Mechanical ileus | 3/5436 (0.1%) | |
| Abdominal pain | 2/5436 (0%) | |
| Pancreatitis acute | 2/5436 (0%) | |
| Rectal ulcer | 2/5436 (0%) | |
| Upper gastrointestinal haemorrhage | 2/5436 (0%) | |
| Large intestine polyp | 2/5436 (0%) | |
| Abdominal distension | 1/5436 (0%) | |
| Abdominal pain upper | 1/5436 (0%) | |
| Diarrhoea | 1/5436 (0%) | |
| Dyspepsia | 1/5436 (0%) | |
| Dysphagia | 1/5436 (0%) | |
| Gastric dilatation | 1/5436 (0%) | |
| Gastric ulcer haemorrhage | 1/5436 (0%) | |
| Haemorrhoids | 1/5436 (0%) | |
| Ileus | 1/5436 (0%) | |
| Incarcerated inguinal hernia | 1/5436 (0%) | |
| Inguinal hernia | 1/5436 (0%) | |
| Oesophageal ulcer | 1/5436 (0%) | |
| Lower gastrointestinal haemorrhage | 1/5436 (0%) | |
| Gastric hypomotility | 1/5436 (0%) | |
| Large intestinal haemorrhage | 1/5436 (0%) | |
| Haemorrhoidal haemorrhage | 1/5436 (0%) | |
| Large intestinal stenosis | 1/5436 (0%) | |
| General disorders | ||
| Death | 6/5436 (0.1%) | |
| Chest discomfort | 2/5436 (0%) | |
| Sudden death | 2/5436 (0%) | |
| Chest pain | 1/5436 (0%) | |
| Generalised oedema | 1/5436 (0%) | |
| Malaise | 1/5436 (0%) | |
| Oedema peripheral | 1/5436 (0%) | |
| Pyrexia | 1/5436 (0%) | |
| Oedema due to cardiac disease | 1/5436 (0%) | |
| Multiple organ dysfunction syndrome | 1/5436 (0%) | |
| Hepatobiliary disorders | ||
| Cholelithiasis | 3/5436 (0.1%) | |
| Acute hepatic failure | 2/5436 (0%) | |
| Cholangitis | 2/5436 (0%) | |
| Cholangitis acute | 2/5436 (0%) | |
| Drug-induced liver injury | 2/5436 (0%) | |
| Bile duct stone | 1/5436 (0%) | |
| Cholecystitis | 1/5436 (0%) | |
| Hepatic cirrhosis | 1/5436 (0%) | |
| Hepatic failure | 1/5436 (0%) | |
| Hepatitis fulminant | 1/5436 (0%) | |
| Jaundice cholestatic | 1/5436 (0%) | |
| Primary biliary cholangitis | 1/5436 (0%) | |
| Infections and infestations | ||
| Pneumonia bacterial | 5/5436 (0.1%) | |
| Pneumonia | 4/5436 (0.1%) | |
| Cellulitis | 2/5436 (0%) | |
| Pyelonephritis acute | 2/5436 (0%) | |
| Bacteraemia | 1/5436 (0%) | |
| Empyema | 1/5436 (0%) | |
| Endocarditis | 1/5436 (0%) | |
| Endophthalmitis | 1/5436 (0%) | |
| Gangrene | 1/5436 (0%) | |
| Influenza | 1/5436 (0%) | |
| Necrotising fasciitis | 1/5436 (0%) | |
| Pseudomembranous colitis | 1/5436 (0%) | |
| Pyelitis | 1/5436 (0%) | |
| Sepsis | 1/5436 (0%) | |
| Tuberculous pleurisy | 1/5436 (0%) | |
| Arthritis bacterial | 1/5436 (0%) | |
| Arthritis infective | 1/5436 (0%) | |
| Infective spondylitis | 1/5436 (0%) | |
| Bacterial prostatitis | 1/5436 (0%) | |
| Infectious pleural effusion | 1/5436 (0%) | |
| Complicated appendicitis | 1/5436 (0%) | |
| Injury, poisoning and procedural complications | ||
| Subdural haematoma | 5/5436 (0.1%) | |
| Fall | 4/5436 (0.1%) | |
| Pelvic fracture | 2/5436 (0%) | |
| Clavicle fracture | 1/5436 (0%) | |
| Femoral neck fracture | 1/5436 (0%) | |
| Femur fracture | 1/5436 (0%) | |
| Fractured sacrum | 1/5436 (0%) | |
| Humerus fracture | 1/5436 (0%) | |
| Rib fracture | 1/5436 (0%) | |
| Spinal compression fracture | 1/5436 (0%) | |
| Contusion | 1/5436 (0%) | |
| Post procedural haemorrhage | 1/5436 (0%) | |
| Incision site haemorrhage | 1/5436 (0%) | |
| Vascular procedure complication | 1/5436 (0%) | |
| Traumatic intracranial haemorrhage | 1/5436 (0%) | |
| Procedural haemorrhage | 1/5436 (0%) | |
| Meniscus injury | 1/5436 (0%) | |
| Investigations | ||
| Heart rate decreased | 1/5436 (0%) | |
| Weight increased | 1/5436 (0%) | |
| Metabolism and nutrition disorders | ||
| Diabetes mellitus | 2/5436 (0%) | |
| Decreased appetite | 2/5436 (0%) | |
| Hypokalaemia | 1/5436 (0%) | |
| Hyponatraemia | 1/5436 (0%) | |
| Marasmus | 1/5436 (0%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthritis | 1/5436 (0%) | |
| Osteoarthritis | 1/5436 (0%) | |
| Pain in extremity | 1/5436 (0%) | |
| Haematoma muscle | 1/5436 (0%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Lung neoplasm malignant | 6/5436 (0.1%) | |
| Colon cancer | 5/5436 (0.1%) | |
| Gastric cancer | 5/5436 (0.1%) | |
| Pancreatic carcinoma | 3/5436 (0.1%) | |
| Rectal cancer | 3/5436 (0.1%) | |
| Prostate cancer | 3/5436 (0.1%) | |
| Metastases to liver | 2/5436 (0%) | |
| Metastases to lymph nodes | 2/5436 (0%) | |
| Plasma cell myeloma | 2/5436 (0%) | |
| Colon adenoma | 2/5436 (0%) | |
| Malignant neoplasm progression | 2/5436 (0%) | |
| Metastases to peritoneum | 2/5436 (0%) | |
| Small intestine carcinoma | 2/5436 (0%) | |
| Hepatocellular carcinoma | 2/5436 (0%) | |
| Angiocentric lymphoma | 1/5436 (0%) | |
| Bile duct cancer | 1/5436 (0%) | |
| Bladder cancer | 1/5436 (0%) | |
| Bone cancer | 1/5436 (0%) | |
| Cholangiocarcinoma | 1/5436 (0%) | |
| Chronic lymphocytic leukaemia | 1/5436 (0%) | |
| Metastases to bone | 1/5436 (0%) | |
| Myelodysplastic syndrome | 1/5436 (0%) | |
| Rectosigmoid cancer | 1/5436 (0%) | |
| Squamous cell carcinoma of lung | 1/5436 (0%) | |
| Uterine cancer | 1/5436 (0%) | |
| Neuroendocrine carcinoma | 1/5436 (0%) | |
| Gastric adenoma | 1/5436 (0%) | |
| Abdominal neoplasm | 1/5436 (0%) | |
| Gastrointestinal neoplasm | 1/5436 (0%) | |
| Lung neoplasm | 1/5436 (0%) | |
| Soft tissue neoplasm | 1/5436 (0%) | |
| Nervous system disorders | ||
| Cerebral infarction | 31/5436 (0.6%) | |
| Embolic cerebral infarction | 6/5436 (0.1%) | |
| Epilepsy | 5/5436 (0.1%) | |
| Haemorrhagic cerebral infarction | 4/5436 (0.1%) | |
| Cerebral artery embolism | 3/5436 (0.1%) | |
| Cerebral haemorrhage | 3/5436 (0.1%) | |
| Embolic stroke | 3/5436 (0.1%) | |
| Cerebrovascular accident | 2/5436 (0%) | |
| Dementia | 2/5436 (0%) | |
| Transient ischaemic attack | 2/5436 (0%) | |
| Lacunar infarction | 2/5436 (0%) | |
| Altered state of consciousness | 1/5436 (0%) | |
| Brain stem infarction | 1/5436 (0%) | |
| Cerebral atrophy | 1/5436 (0%) | |
| Depressed level of consciousness | 1/5436 (0%) | |
| Dizziness | 1/5436 (0%) | |
| Facial paralysis | 1/5436 (0%) | |
| Myelopathy | 1/5436 (0%) | |
| Neuralgia | 1/5436 (0%) | |
| Paralysis | 1/5436 (0%) | |
| Paraparesis | 1/5436 (0%) | |
| Status epilepticus | 1/5436 (0%) | |
| Subarachnoid haemorrhage | 1/5436 (0%) | |
| Syncope | 1/5436 (0%) | |
| Visual field defect | 1/5436 (0%) | |
| Carotid artery occlusion | 1/5436 (0%) | |
| Carotid artery dissection | 1/5436 (0%) | |
| Cerebral disorder | 1/5436 (0%) | |
| Psychiatric disorders | ||
| Delirium | 2/5436 (0%) | |
| Renal and urinary disorders | ||
| Acute kidney injury | 6/5436 (0.1%) | |
| Renal impairment | 3/5436 (0.1%) | |
| Renal failure | 2/5436 (0%) | |
| Urinary retention | 2/5436 (0%) | |
| Calculus urinary | 1/5436 (0%) | |
| Haematuria | 1/5436 (0%) | |
| Nephrolithiasis | 1/5436 (0%) | |
| Renal infarct | 1/5436 (0%) | |
| Postrenal failure | 1/5436 (0%) | |
| Chronic kidney disease | 1/5436 (0%) | |
| Reproductive system and breast disorders | ||
| Benign prostatic hyperplasia | 2/5436 (0%) | |
| Prostatic haemorrhage | 1/5436 (0%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Interstitial lung disease | 6/5436 (0.1%) | |
| Dyspnoea | 2/5436 (0%) | |
| Epistaxis | 2/5436 (0%) | |
| Pleural effusion | 2/5436 (0%) | |
| Pneumonia aspiration | 2/5436 (0%) | |
| Pulmonary embolism | 2/5436 (0%) | |
| Respiratory failure | 2/5436 (0%) | |
| Acute respiratory failure | 1/5436 (0%) | |
| Asthma | 1/5436 (0%) | |
| Chronic obstructive pulmonary disease | 1/5436 (0%) | |
| Haemoptysis | 1/5436 (0%) | |
| Pneumothorax | 1/5436 (0%) | |
| Respiratory arrest | 1/5436 (0%) | |
| Obstructive airways disorder | 1/5436 (0%) | |
| Bronchial haemorrhage | 1/5436 (0%) | |
| Organising pneumonia | 1/5436 (0%) | |
| Skin and subcutaneous tissue disorders | ||
| Dermatomyositis | 1/5436 (0%) | |
| Eczema nummular | 1/5436 (0%) | |
| Stevens-Johnson syndrome | 1/5436 (0%) | |
| Surgical and medical procedures | ||
| Cardiac pacemaker insertion | 1/5436 (0%) | |
| Finger amputation | 1/5436 (0%) | |
| Mitral valve replacement | 1/5436 (0%) | |
| Valvuloplasty cardiac | 1/5436 (0%) | |
| Cardiac ablation | 1/5436 (0%) | |
| Cardiac operation | 1/5436 (0%) | |
| Vascular disorders | ||
| Peripheral arterial occlusive disease | 5/5436 (0.1%) | |
| Circulatory collapse | 3/5436 (0.1%) | |
| Deep vein thrombosis | 3/5436 (0.1%) | |
| Arterial occlusive disease | 3/5436 (0.1%) | |
| Embolism arterial | 2/5436 (0%) | |
| Haemorrhagic infarction | 2/5436 (0%) | |
| Aortic aneurysm | 1/5436 (0%) | |
| Aortic aneurysm rupture | 1/5436 (0%) | |
| Aortic dissection | 1/5436 (0%) | |
| Arteriovenous fistula | 1/5436 (0%) | |
| Shock haemorrhagic | 1/5436 (0%) | |
| Arterial stenosis | 1/5436 (0%) | |
| Atheroembolism | 1/5436 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Patients With Nonvalvular Atrial Fibrillation (NVAF) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/5436 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Boehringer Ingelheim, Call Center |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03175198
Other Study ID Numbers:
- 1160-0284
First Posted:
Jun 5, 2017
Last Update Posted:
Apr 6, 2022
Last Verified:
Feb 1, 2022