J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00659581
Collaborator
(none)
21,471
Study Details
Study Description
Brief Summary
The primary objective of this post marketing survey is to prospectively investigate patients with hypertension treated with Micardis Tablets (hereinafter "this drug") in routine clinical settings for 3 years in order to determine the following:
-
Adverse events and adverse drug reactions under long-term use
-
Blood pressure measurements during the survey period
-
Determination of the incidence of cerebrovascular and cardiovascular events under use of this drug in routine clinical settings
-
Patient's lifestyle and background factors that are considered to affect the occurrence of cerebrovascular and cardiovascular events
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
21471 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Special Survey (Survey on Cerebrovascular and Cardiovascular Events Under Long-term Use) of Micardis Tablets (Telmisartan)
Study Start Date
:
Apr 1, 2006
Actual Primary Completion Date
:
Jun 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with hypertension
|
Drug: Telmisartan
Oral administration
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events [3 years after initiation of treatment]
Secondary Outcome Measures
- Change From Baseline in Systolic Blood Pressure at 6 Months [initiation and 6 months]
- Change From Baseline in Diastolic Blood Pressure at 6 Months [initiation and 6 months]
- Change From Baseline in Systolic Blood Pressure at 12 Months [initiation and 12 months]
- Change From Baseline in Diastolic Blood Pressure at 12 Months [initiation and 12 months]
- Change From Baseline in Systolic Blood Pressure at 24 Months [initiation and 24 months]
- Change From Baseline in Diastolic Blood Pressure at 24 Months [initiation and 24 months]
- Change From Baseline in Systolic Blood Pressure at 36 Months [initiation and 36 months]
- Change From Baseline in Diastolic Blood Pressure at 36 Months [initiation and 36 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
Hypertension patients unadministered Micardis.
Exclusion criteria:
-
Patients with a history of hypersensitivity to any ingredient of this product.
-
Pregnant woman or possibly pregnant woman
-
Patients with extremely poor bile secretion or patients with serious hepatic disorder
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00659581
Other Study ID Numbers:
- 502.511
First Posted:
Apr 16, 2008
Last Update Posted:
Aug 25, 2016
Last Verified:
Jul 1, 2016
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | In the survey, 21,433 patients were enrolled. The data of 439 patients have not reported after the registration, and 551 patients were not observed after the registration: 38 entry violation, 24 contract violation, 493 no office visit after initial prescription and 9 undefined study medication (the numbers were overlapping). |
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Period Title: Overall Study | |
| STARTED | 20994 |
| COMPLETED | 12412 |
| NOT COMPLETED | 8582 |
Baseline Characteristics
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Overall Participants | 20443 |
| Age (years old) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years old] |
64.6
(12.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10278
50.3%
|
| Male |
10165
49.7%
|
Outcome Measures
| Title | Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events |
|---|---|
| Description | |
| Time Frame | 3 years after initiation of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All of observed 20,443 patients were included as intention to treat set |
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Measure Participants | 20443 |
| Number of patients with CeV and CaV events |
479
2.3%
|
| Number of patients with no CeV and CaV events |
19964
97.7%
|
| Title | Change From Baseline in Systolic Blood Pressure at 6 Months |
|---|---|
| Description | |
| Time Frame | initiation and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 2503 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 6 months were excluded. |
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Measure Participants | 17940 |
| Mean (Standard Deviation) [mmHg] |
-20.6
(19.9)
|
| Title | Change From Baseline in Diastolic Blood Pressure at 6 Months |
|---|---|
| Description | |
| Time Frame | initiation and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 2506 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 6 months were excluded. |
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Measure Participants | 17937 |
| Mean (Standard Deviation) [mmHg] |
-10.3
(12.5)
|
| Title | Change From Baseline in Systolic Blood Pressure at 12 Months |
|---|---|
| Description | |
| Time Frame | initiation and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 4400 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 12 months were excluded. |
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Measure Participants | 16043 |
| Mean (Standard Deviation) [mmHg] |
-22.2
(19.9)
|
| Title | Change From Baseline in Diastolic Blood Pressure at 12 Months |
|---|---|
| Description | |
| Time Frame | initiation and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 4400 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 12 months were excluded. |
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Measure Participants | 16043 |
| Mean (Standard Deviation) [mmHg] |
-11.3
(12.8)
|
| Title | Change From Baseline in Systolic Blood Pressure at 24 Months |
|---|---|
| Description | |
| Time Frame | initiation and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 6544 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 24 months were excluded. |
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Measure Participants | 13899 |
| Mean (Standard Deviation) [mmHg] |
-23.9
(20.2)
|
| Title | Change From Baseline in Diastolic Blood Pressure at 24 Months |
|---|---|
| Description | |
| Time Frame | initiation and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 6544 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 24 months were excluded. |
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Measure Participants | 13899 |
| Mean (Standard Deviation) [mmHg] |
-12.3
(12.8)
|
| Title | Change From Baseline in Systolic Blood Pressure at 36 Months |
|---|---|
| Description | |
| Time Frame | initiation and 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 8267 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 36 months were excluded. |
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Measure Participants | 12176 |
| Mean (Standard Deviation) [mmHg] |
-25.0
(19.9)
|
| Title | Change From Baseline in Diastolic Blood Pressure at 36 Months |
|---|---|
| Description | |
| Time Frame | initiation and 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 8270 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 36 months were excluded. |
| Arm/Group Title | Telmisartan |
|---|---|
| Arm/Group Description | |
| Measure Participants | 12173 |
| Mean (Standard Deviation) [mmHg] |
-13.1
(13.0)
|
Adverse Events
| Time Frame | From signing the informed consent through the end of study | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Telmisartan | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Telmisartan | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Telmisartan | ||
| Affected / at Risk (%) | # Events | |
| Total | 1058/20443 (5.2%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 3/20443 (0%) | |
| Aplastic anaemia | 2/20443 (0%) | |
| Blood disorder | 1/20443 (0%) | |
| Disseminated intravascular coagulation | 1/20443 (0%) | |
| Erythropenia | 1/20443 (0%) | |
| Granulocytopenia | 1/20443 (0%) | |
| Iron deficiency anaemia | 2/20443 (0%) | |
| Microcytic anaemia | 1/20443 (0%) | |
| Cardiac disorders | ||
| Acute myocardial infarction | 12/20443 (0.1%) | |
| Angina pectoris | 90/20443 (0.4%) | |
| Angina unstable | 3/20443 (0%) | |
| Aortic valve disease mixed | 1/20443 (0%) | |
| Aortic valve incompetence | 2/20443 (0%) | |
| Aortic valve stenosis | 1/20443 (0%) | |
| Arteriosclerosis coronary artery | 1/20443 (0%) | |
| Atrial fibrillation | 8/20443 (0%) | |
| Atrioventricular block complete | 4/20443 (0%) | |
| Bradycardia | 1/20443 (0%) | |
| Cardiac failure | 76/20443 (0.4%) | |
| Cardiac failure acute | 2/20443 (0%) | |
| Cardiac failure chronic | 4/20443 (0%) | |
| Cardiac failure congestive | 5/20443 (0%) | |
| Cardiac sarcoidosis | 1/20443 (0%) | |
| Coronary artery stenosis | 1/20443 (0%) | |
| Hypertrophic cardiomyopathy | 1/20443 (0%) | |
| Mitral valve incompetence | 2/20443 (0%) | |
| Myocardial infarction | 58/20443 (0.3%) | |
| Myocardial ischaemia | 1/20443 (0%) | |
| Myocardial rupture | 1/20443 (0%) | |
| Prinzmetal angina | 2/20443 (0%) | |
| Sick sinus syndrome | 3/20443 (0%) | |
| Supraventricular extrasystoles | 1/20443 (0%) | |
| Tachycardia | 1/20443 (0%) | |
| Ventricular extrasystoles | 1/20443 (0%) | |
| Ventricular fibrillation | 2/20443 (0%) | |
| Ventricular tachycardia | 3/20443 (0%) | |
| Congenital, familial and genetic disorders | ||
| Congenital cystic kidney disease | 1/20443 (0%) | |
| Ear and labyrinth disorders | ||
| Vertigo | 1/20443 (0%) | |
| Endocrine disorders | ||
| Primary hyperaldosteronism | 1/20443 (0%) | |
| Eye disorders | ||
| Cataract | 3/20443 (0%) | |
| Retinal detachment | 1/20443 (0%) | |
| Retinal haemorrhage | 1/20443 (0%) | |
| Vitreous haemorrhage | 1/20443 (0%) | |
| Gastrointestinal disorders | ||
| Alcoholic pancreatitis | 1/20443 (0%) | |
| Ascites | 3/20443 (0%) | |
| Colitis ischaemic | 2/20443 (0%) | |
| Colitis ulcerative | 1/20443 (0%) | |
| Colonic polyp | 5/20443 (0%) | |
| Diverticular perforation | 1/20443 (0%) | |
| Duodenal ulcer | 2/20443 (0%) | |
| Duodenal ulcer haemorrhage | 1/20443 (0%) | |
| Gastric ulcer | 3/20443 (0%) | |
| Gastric ulcer haemorrhage | 5/20443 (0%) | |
| Gastrointestinal haemorrhage | 3/20443 (0%) | |
| Haematemesis | 1/20443 (0%) | |
| Ileus | 5/20443 (0%) | |
| Intestinal obstruction | 4/20443 (0%) | |
| Large intestinal haemorrhage | 1/20443 (0%) | |
| Large intestine perforation | 1/20443 (0%) | |
| Melaena | 1/20443 (0%) | |
| Mesenteric occlusion | 1/20443 (0%) | |
| Pancreatitis | 2/20443 (0%) | |
| Pancreatitis acute | 1/20443 (0%) | |
| Peritonitis | 3/20443 (0%) | |
| Rectal lesion | 1/20443 (0%) | |
| Vomiting | 1/20443 (0%) | |
| General disorders | ||
| Chest pain | 1/20443 (0%) | |
| Condition aggravated | 1/20443 (0%) | |
| Death | 35/20443 (0.2%) | |
| Drowning | 1/20443 (0%) | |
| Gait disturbance | 1/20443 (0%) | |
| General physical health deterioration | 3/20443 (0%) | |
| Multi-organ failure | 2/20443 (0%) | |
| Oedema peripheral | 1/20443 (0%) | |
| Hepatobiliary disorders | ||
| Alcoholic liver disease | 2/20443 (0%) | |
| Autoimmune hepatitis | 1/20443 (0%) | |
| Bile duct stone | 4/20443 (0%) | |
| Cholangitis | 1/20443 (0%) | |
| Cholecystitis acute | 2/20443 (0%) | |
| Cholelithiasis | 2/20443 (0%) | |
| Cholestasis | 1/20443 (0%) | |
| Hepatic cirrhosis | 4/20443 (0%) | |
| Hepatic failure | 1/20443 (0%) | |
| Hepatic function abnormal | 1/20443 (0%) | |
| Hepatitis acute | 2/20443 (0%) | |
| Jaundice | 1/20443 (0%) | |
| Liver disorder | 3/20443 (0%) | |
| Infections and infestations | ||
| Appendicitis | 1/20443 (0%) | |
| Arteriosclerotic gangrene | 1/20443 (0%) | |
| Bronchopneumonia | 2/20443 (0%) | |
| Cellulitis | 2/20443 (0%) | |
| Dacryocystitis | 1/20443 (0%) | |
| Diabetic gangrene | 1/20443 (0%) | |
| Endocarditis | 2/20443 (0%) | |
| Gallbladder abscess | 1/20443 (0%) | |
| Gangrene | 2/20443 (0%) | |
| Gastroenteritis | 1/20443 (0%) | |
| Hepatitis C | 1/20443 (0%) | |
| Herpes zoster | 1/20443 (0%) | |
| Influenza | 1/20443 (0%) | |
| Liver abscess | 1/20443 (0%) | |
| Lobar pneumonia | 2/20443 (0%) | |
| Meningitis | 1/20443 (0%) | |
| Otitis media | 2/20443 (0%) | |
| Peritoneal tuberculosis | 1/20443 (0%) | |
| Pneumonia | 16/20443 (0.1%) | |
| Pneumonia bacterial | 11/20443 (0.1%) | |
| Pneumonia fungal | 1/20443 (0%) | |
| Postoperative wound infection | 1/20443 (0%) | |
| Pseudomembranous colitis | 1/20443 (0%) | |
| Pulmonary tuberculoma | 1/20443 (0%) | |
| Pulmonary tuberculosis | 1/20443 (0%) | |
| Pyelonephritis | 2/20443 (0%) | |
| Pyelonephritis acute | 1/20443 (0%) | |
| Pyometra | 1/20443 (0%) | |
| Sepsis | 9/20443 (0%) | |
| Septic shock | 1/20443 (0%) | |
| Tuberculous pleurisy | 1/20443 (0%) | |
| Urinary tract infection | 4/20443 (0%) | |
| Injury, poisoning and procedural complications | ||
| Accident | 1/20443 (0%) | |
| Brain contusion | 1/20443 (0%) | |
| Contusion | 1/20443 (0%) | |
| Extradural haematoma | 1/20443 (0%) | |
| Fall | 11/20443 (0.1%) | |
| Femoral neck fracture | 10/20443 (0%) | |
| Femur fracture | 5/20443 (0%) | |
| Foot fracture | 1/20443 (0%) | |
| Fracture | 5/20443 (0%) | |
| Head injury | 1/20443 (0%) | |
| Heat illness | 1/20443 (0%) | |
| Hip fracture | 1/20443 (0%) | |
| Humerus fracture | 1/20443 (0%) | |
| In-stent arterial restenosis | 1/20443 (0%) | |
| Internal injury | 1/20443 (0%) | |
| Lower limb fracture | 1/20443 (0%) | |
| Lumbar vertebral fracture | 1/20443 (0%) | |
| Postoperative ileus | 1/20443 (0%) | |
| Rib fracture | 2/20443 (0%) | |
| Road traffic accident | 5/20443 (0%) | |
| Shunt occlusion | 1/20443 (0%) | |
| Spinal compression fracture | 1/20443 (0%) | |
| Subdural haematoma | 6/20443 (0%) | |
| Uterine rupture | 1/20443 (0%) | |
| Wrist fracture | 1/20443 (0%) | |
| Investigations | ||
| Blood creatinine increased | 2/20443 (0%) | |
| Blood pressure decreased | 1/20443 (0%) | |
| Blood pressure increased | 1/20443 (0%) | |
| Glucose urine present | 1/20443 (0%) | |
| Haemoglobin decreased | 1/20443 (0%) | |
| Protein urine present | 1/20443 (0%) | |
| Weight increased | 1/20443 (0%) | |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 3/20443 (0%) | |
| Dehydration | 3/20443 (0%) | |
| Diabetes mellitus | 11/20443 (0.1%) | |
| Diabetes mellitus inadequate control | 1/20443 (0%) | |
| Hypercholesterolaemia | 1/20443 (0%) | |
| Hyperkalaemia | 16/20443 (0.1%) | |
| Hypoglycaemia | 2/20443 (0%) | |
| Hyponatraemia | 1/20443 (0%) | |
| Hypophagia | 1/20443 (0%) | |
| Marasmus | 5/20443 (0%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 1/20443 (0%) | |
| Bursitis | 2/20443 (0%) | |
| Cervical spinal stenosis | 1/20443 (0%) | |
| Collagen disorder | 1/20443 (0%) | |
| Lumbar spinal stenosis | 1/20443 (0%) | |
| Neuropathic arthropathy | 1/20443 (0%) | |
| Pathological fracture | 1/20443 (0%) | |
| Rhabdomyolysis | 1/20443 (0%) | |
| Spinal column stenosis | 2/20443 (0%) | |
| Spinal osteoarthritis | 1/20443 (0%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Abdominal neoplasm | 1/20443 (0%) | |
| Acute myeloid leukaemia | 2/20443 (0%) | |
| Adenocarcinoma | 1/20443 (0%) | |
| Adenocarcinoma pancreas | 1/20443 (0%) | |
| Adult T-cell lymphoma/leukaemia | 3/20443 (0%) | |
| Bile duct cancer | 5/20443 (0%) | |
| Bladder cancer | 4/20443 (0%) | |
| Bladder neoplasm | 1/20443 (0%) | |
| Brain neoplasm | 5/20443 (0%) | |
| Breast cancer | 4/20443 (0%) | |
| Breast cancer recurrent | 2/20443 (0%) | |
| Cardiac myxoma | 1/20443 (0%) | |
| Chronic myeloid leukaemia | 1/20443 (0%) | |
| Colon adenoma | 1/20443 (0%) | |
| Colon cancer | 7/20443 (0%) | |
| Gallbladder cancer | 3/20443 (0%) | |
| Gastric cancer | 42/20443 (0.2%) | |
| Gastric cancer recurrent | 1/20443 (0%) | |
| Gastric neoplasm | 1/20443 (0%) | |
| Hepatic cancer metastatic | 2/20443 (0%) | |
| Hepatic neoplasm | 3/20443 (0%) | |
| Hepatic neoplasm malignant | 7/20443 (0%) | |
| Hepatic neoplasm malignant recurrent | 3/20443 (0%) | |
| Hypopharyngeal cancer | 1/20443 (0%) | |
| Large intestine carcinoma | 26/20443 (0.1%) | |
| Lip and/or oral cavity cancer | 1/20443 (0%) | |
| Liposarcoma | 1/20443 (0%) | |
| Lung cancer metastatic | 1/20443 (0%) | |
| Lung carcinoma cell type unspecified recurrent | 2/20443 (0%) | |
| Lung neoplasm malignant | 32/20443 (0.2%) | |
| Lymphoma | 2/20443 (0%) | |
| Malignant ascites | 1/20443 (0%) | |
| Malignant pleural effusion | 1/20443 (0%) | |
| Metastases to bone | 4/20443 (0%) | |
| Metastases to central nervous system | 2/20443 (0%) | |
| Metastases to liver | 1/20443 (0%) | |
| Metastases to lung | 2/20443 (0%) | |
| Metastases to lymph nodes | 1/20443 (0%) | |
| Metastases to meninges | 1/20443 (0%) | |
| Metastatic neoplasm | 1/20443 (0%) | |
| Multiple myeloma | 1/20443 (0%) | |
| Myelodysplastic syndrome | 1/20443 (0%) | |
| Neoplasm malignant | 1/20443 (0%) | |
| Oesophageal carcinoma | 8/20443 (0%) | |
| Oesophageal carcinoma recurrent | 1/20443 (0%) | |
| Ovarian cancer | 3/20443 (0%) | |
| Ovarian neoplasm | 1/20443 (0%) | |
| Pancreatic carcinoma | 11/20443 (0.1%) | |
| Pancreatic carcinoma recurrent | 1/20443 (0%) | |
| Pharyngeal cancer stage unspecified | 1/20443 (0%) | |
| Pleural mesothelioma malignant | 1/20443 (0%) | |
| Prostate cancer | 7/20443 (0%) | |
| Prostate cancer recurrent | 1/20443 (0%) | |
| Rectal cancer | 6/20443 (0%) | |
| Rectosigmoid cancer | 2/20443 (0%) | |
| Renal cancer | 4/20443 (0%) | |
| Retroperitoneal cancer | 1/20443 (0%) | |
| Salivary gland adenoma | 1/20443 (0%) | |
| Salivary gland neoplasm | 1/20443 (0%) | |
| Thymoma malignant | 1/20443 (0%) | |
| Thyroid cancer | 2/20443 (0%) | |
| Ureteric cancer | 1/20443 (0%) | |
| Nervous system disorders | ||
| Altered state of consciousness | 1/20443 (0%) | |
| Amnesia | 1/20443 (0%) | |
| Amyotrophic lateral sclerosis | 2/20443 (0%) | |
| Brain stem haemorrhage | 2/20443 (0%) | |
| Brain stem infarction | 1/20443 (0%) | |
| Carotid artery stenosis | 2/20443 (0%) | |
| Cerebellar haemorrhage | 1/20443 (0%) | |
| Cerebellar infarction | 1/20443 (0%) | |
| Cerebral artery occlusion | 1/20443 (0%) | |
| Cerebral haemorrhage | 31/20443 (0.2%) | |
| Cerebral infarction | 169/20443 (0.8%) | |
| Convulsion | 1/20443 (0%) | |
| Dementia | 6/20443 (0%) | |
| Dementia Alzheimer's type | 1/20443 (0%) | |
| Dizziness | 3/20443 (0%) | |
| Dyskinesia | 1/20443 (0%) | |
| Embolic stroke | 1/20443 (0%) | |
| Hydrocephalus | 1/20443 (0%) | |
| Hypertensive encephalopathy | 1/20443 (0%) | |
| IIIrd nerve paralysis | 1/20443 (0%) | |
| Intracranial aneurysm | 1/20443 (0%) | |
| Loss of consciousness | 2/20443 (0%) | |
| Monoplegia | 1/20443 (0%) | |
| Myasthenia gravis | 1/20443 (0%) | |
| Quadriplegia | 1/20443 (0%) | |
| Subarachnoid haemorrhage | 13/20443 (0.1%) | |
| Transient ischaemic attack | 22/20443 (0.1%) | |
| Vertebral artery stenosis | 1/20443 (0%) | |
| Psychiatric disorders | ||
| Abnormal behaviour | 1/20443 (0%) | |
| Alcoholism | 1/20443 (0%) | |
| Completed suicide | 2/20443 (0%) | |
| Delirium | 1/20443 (0%) | |
| Depression | 5/20443 (0%) | |
| Eating disorder | 1/20443 (0%) | |
| Renal and urinary disorders | ||
| Calculus ureteric | 4/20443 (0%) | |
| Diabetic nephropathy | 13/20443 (0.1%) | |
| Focal segmental glomerulosclerosis | 1/20443 (0%) | |
| Glomerulonephritis chronic | 2/20443 (0%) | |
| Hydronephrosis | 1/20443 (0%) | |
| Lupus nephritis | 1/20443 (0%) | |
| Mesangioproliferative glomerulonephritis | 1/20443 (0%) | |
| Nephrolithiasis | 1/20443 (0%) | |
| Nephropathy | 1/20443 (0%) | |
| Nephrosclerosis | 1/20443 (0%) | |
| Nephrotic syndrome | 4/20443 (0%) | |
| Renal artery stenosis | 1/20443 (0%) | |
| Renal failure | 9/20443 (0%) | |
| Renal failure acute | 4/20443 (0%) | |
| Renal failure chronic | 23/20443 (0.1%) | |
| Renal impairment | 6/20443 (0%) | |
| Urinary incontinence | 1/20443 (0%) | |
| Reproductive system and breast disorders | ||
| Benign prostatic hyperplasia | 1/20443 (0%) | |
| Endometriosis | 1/20443 (0%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Acute respiratory distress syndrome | 1/20443 (0%) | |
| Acute respiratory failure | 1/20443 (0%) | |
| Asphyxia | 1/20443 (0%) | |
| Aspiration | 1/20443 (0%) | |
| Asthma | 4/20443 (0%) | |
| Caplanas syndrome | 1/20443 (0%) | |
| Chronic respiratory failure | 1/20443 (0%) | |
| Emphysema | 1/20443 (0%) | |
| Haemoptysis | 1/20443 (0%) | |
| Haemothorax | 1/20443 (0%) | |
| Interstitial lung disease | 9/20443 (0%) | |
| Obstructive airways disorder | 1/20443 (0%) | |
| Organising pneumonia | 1/20443 (0%) | |
| Pleurisy | 1/20443 (0%) | |
| Pneumonia aspiration | 9/20443 (0%) | |
| Pneumothorax | 1/20443 (0%) | |
| Pulmonary alveolar haemorrhage | 1/20443 (0%) | |
| Pulmonary embolism | 2/20443 (0%) | |
| Pulmonary oedema | 2/20443 (0%) | |
| Respiratory failure | 6/20443 (0%) | |
| Sleep apnoea syndrome | 1/20443 (0%) | |
| Surgical and medical procedures | ||
| Aortic anastomosis | 1/20443 (0%) | |
| Aortic valve replacement | 2/20443 (0%) | |
| Coronary angioplasty | 1/20443 (0%) | |
| Dialysis device insertion | 1/20443 (0%) | |
| Orthopedic procedure | 1/20443 (0%) | |
| Vascular graft | 1/20443 (0%) | |
| Vascular disorders | ||
| Aneurysm | 1/20443 (0%) | |
| Aortic aneurysm | 6/20443 (0%) | |
| Aortic aneurysm rupture | 1/20443 (0%) | |
| Aortic dissection | 5/20443 (0%) | |
| Aortic occlusion | 1/20443 (0%) | |
| Aortic rupture | 1/20443 (0%) | |
| Arterial occlusive disease | 1/20443 (0%) | |
| Arterial thrombosis limb | 1/20443 (0%) | |
| Arteriosclerosis obliterans | 7/20443 (0%) | |
| Blood pressure inadequately controlled | 1/20443 (0%) | |
| Deep vein thrombosis | 2/20443 (0%) | |
| Haemorrhage | 1/20443 (0%) | |
| Hypotension | 2/20443 (0%) | |
| Intermittent claudication | 2/20443 (0%) | |
| Shock | 1/20443 (0%) | |
| Shock haemorrhagic | 1/20443 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Telmisartan | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/20443 (0%) | |
Limitations/Caveats
This study is prospective observational study with no limitation of other antihypertensive treatment in compliance with Japanese Pharmaceutical Affairs Law (JPAL) and Good Post-marketing Study Practice (GPSP).
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 Pharmaceuticals |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00659581
Other Study ID Numbers:
- 502.511
First Posted:
Apr 16, 2008
Last Update Posted:
Aug 25, 2016
Last Verified:
Jul 1, 2016