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J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659581
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : March 20, 2012
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Hypertension
Intervention Drug: Telmisartan
Enrollment 21471
Recruitment Details  
Pre-assignment Details 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
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 20994
Completed 12412
Not Completed 8582
Reason Not Completed
Adverse Event             1006
Lack of Efficacy             1183
Other             6393
Arm/Group Title Telmisartan
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 20443
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years old
Number Analyzed 20443 participants
64.6  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20443 participants
Female
10278
  50.3%
Male
10165
  49.7%
1.Primary Outcome
Title Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events
Hide Description [Not Specified]
Time Frame 3 years after initiation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All of observed 20,443 patients were included as intention to treat set
Arm/Group Title Telmisartan
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 20443
Measure Type: Number
Unit of Measure: Number of participants
Number of patients with CeV and CaV events 479
Number of patients with no CeV and CaV events 19964
2.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure at 6 Months
Hide Description [Not Specified]
Time Frame initiation and 6 months
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 17940
Mean (Standard Deviation)
Unit of Measure: mmHg
-20.6  (19.9)
3.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure at 6 Months
Hide Description [Not Specified]
Time Frame initiation and 6 months
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 17937
Mean (Standard Deviation)
Unit of Measure: mmHg
-10.3  (12.5)
4.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure at 12 Months
Hide Description [Not Specified]
Time Frame initiation and 12 months
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 16043
Mean (Standard Deviation)
Unit of Measure: mmHg
-22.2  (19.9)
5.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure at 12 Months
Hide Description [Not Specified]
Time Frame initiation and 12 months
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 16043
Mean (Standard Deviation)
Unit of Measure: mmHg
-11.3  (12.8)
6.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure at 24 Months
Hide Description [Not Specified]
Time Frame initiation and 24 months
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 13899
Mean (Standard Deviation)
Unit of Measure: mmHg
-23.9  (20.2)
7.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure at 24 Months
Hide Description [Not Specified]
Time Frame initiation and 24 months
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 13899
Mean (Standard Deviation)
Unit of Measure: mmHg
-12.3  (12.8)
8.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure at 36 Months
Hide Description [Not Specified]
Time Frame initiation and 36 months
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12176
Mean (Standard Deviation)
Unit of Measure: mmHg
-25.0  (19.9)
9.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure at 36 Months
Hide Description [Not Specified]
Time Frame initiation and 36 months
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12173
Mean (Standard Deviation)
Unit of Measure: mmHg
-13.1  (13.0)
Time Frame From signing the informed consent through the end of study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telmisartan
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Telmisartan
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telmisartan
Affected / at Risk (%)
Total   1058/20443 (5.18%) 
Blood and lymphatic system disorders   
Anaemia  1  3/20443 (0.01%) 
Aplastic anaemia  1  2/20443 (0.01%) 
Blood disorder  1  1/20443 (0.00%) 
Disseminated intravascular coagulation  1  1/20443 (0.00%) 
Erythropenia  1  1/20443 (0.00%) 
Granulocytopenia  1  1/20443 (0.00%) 
Iron deficiency anaemia  1  2/20443 (0.01%) 
Microcytic anaemia  1  1/20443 (0.00%) 
Cardiac disorders   
Acute myocardial infarction  1  12/20443 (0.06%) 
Angina pectoris  1  90/20443 (0.44%) 
Angina unstable  1  3/20443 (0.01%) 
Aortic valve disease mixed  1  1/20443 (0.00%) 
Aortic valve incompetence  1  2/20443 (0.01%) 
Aortic valve stenosis  1  1/20443 (0.00%) 
Arteriosclerosis coronary artery  1  1/20443 (0.00%) 
Atrial fibrillation  1  8/20443 (0.04%) 
Atrioventricular block complete  1  4/20443 (0.02%) 
Bradycardia  1  1/20443 (0.00%) 
Cardiac failure  1  76/20443 (0.37%) 
Cardiac failure acute  1  2/20443 (0.01%) 
Cardiac failure chronic  1  4/20443 (0.02%) 
Cardiac failure congestive  1  5/20443 (0.02%) 
Cardiac sarcoidosis  1  1/20443 (0.00%) 
Coronary artery stenosis  1  1/20443 (0.00%) 
Hypertrophic cardiomyopathy  1  1/20443 (0.00%) 
Mitral valve incompetence  1  2/20443 (0.01%) 
Myocardial infarction  1  58/20443 (0.28%) 
Myocardial ischaemia  1  1/20443 (0.00%) 
Myocardial rupture  1  1/20443 (0.00%) 
Prinzmetal angina  1  2/20443 (0.01%) 
Sick sinus syndrome  1  3/20443 (0.01%) 
Supraventricular extrasystoles  1  1/20443 (0.00%) 
Tachycardia  1  1/20443 (0.00%) 
Ventricular extrasystoles  1  1/20443 (0.00%) 
Ventricular fibrillation  1  2/20443 (0.01%) 
Ventricular tachycardia  1  3/20443 (0.01%) 
Congenital, familial and genetic disorders   
Congenital cystic kidney disease  1  1/20443 (0.00%) 
Ear and labyrinth disorders   
Vertigo  1  1/20443 (0.00%) 
Endocrine disorders   
Primary hyperaldosteronism  1  1/20443 (0.00%) 
Eye disorders   
Cataract  1  3/20443 (0.01%) 
Retinal detachment  1  1/20443 (0.00%) 
Retinal haemorrhage  1  1/20443 (0.00%) 
Vitreous haemorrhage  1  1/20443 (0.00%) 
Gastrointestinal disorders   
Alcoholic pancreatitis  1  1/20443 (0.00%) 
Ascites  1  3/20443 (0.01%) 
Colitis ischaemic  1  2/20443 (0.01%) 
Colitis ulcerative  1  1/20443 (0.00%) 
Colonic polyp  1  5/20443 (0.02%) 
Diverticular perforation  1  1/20443 (0.00%) 
Duodenal ulcer  1  2/20443 (0.01%) 
Duodenal ulcer haemorrhage  1  1/20443 (0.00%) 
Gastric ulcer  1  3/20443 (0.01%) 
Gastric ulcer haemorrhage  1  5/20443 (0.02%) 
Gastrointestinal haemorrhage  1  3/20443 (0.01%) 
Haematemesis  1  1/20443 (0.00%) 
Ileus  1  5/20443 (0.02%) 
Intestinal obstruction  1  4/20443 (0.02%) 
Large intestinal haemorrhage  1  1/20443 (0.00%) 
Large intestine perforation  1  1/20443 (0.00%) 
Melaena  1  1/20443 (0.00%) 
Mesenteric occlusion  1  1/20443 (0.00%) 
Pancreatitis  1  2/20443 (0.01%) 
Pancreatitis acute  1  1/20443 (0.00%) 
Peritonitis  1  3/20443 (0.01%) 
Rectal lesion  1  1/20443 (0.00%) 
Vomiting  1  1/20443 (0.00%) 
General disorders   
Chest pain  1  1/20443 (0.00%) 
Condition aggravated  1  1/20443 (0.00%) 
Death  1  35/20443 (0.17%) 
Drowning  1  1/20443 (0.00%) 
Gait disturbance  1  1/20443 (0.00%) 
General physical health deterioration  1  3/20443 (0.01%) 
Multi−organ failure  1  2/20443 (0.01%) 
Oedema peripheral  1  1/20443 (0.00%) 
Hepatobiliary disorders   
Alcoholic liver disease  1  2/20443 (0.01%) 
Autoimmune hepatitis  1  1/20443 (0.00%) 
Bile duct stone  1  4/20443 (0.02%) 
Cholangitis  1  1/20443 (0.00%) 
Cholecystitis acute  1  2/20443 (0.01%) 
Cholelithiasis  1  2/20443 (0.01%) 
Cholestasis  1  1/20443 (0.00%) 
Hepatic cirrhosis  1  4/20443 (0.02%) 
Hepatic failure  1  1/20443 (0.00%) 
Hepatic function abnormal  1  1/20443 (0.00%) 
Hepatitis acute  1  2/20443 (0.01%) 
Jaundice  1  1/20443 (0.00%) 
Liver disorder  1  3/20443 (0.01%) 
Infections and infestations   
Appendicitis  1  1/20443 (0.00%) 
Arteriosclerotic gangrene  1  1/20443 (0.00%) 
Bronchopneumonia  1  2/20443 (0.01%) 
Cellulitis  1  2/20443 (0.01%) 
Dacryocystitis  1  1/20443 (0.00%) 
Diabetic gangrene  1  1/20443 (0.00%) 
Endocarditis  1  2/20443 (0.01%) 
Gallbladder abscess  1  1/20443 (0.00%) 
Gangrene  1  2/20443 (0.01%) 
Gastroenteritis  1  1/20443 (0.00%) 
Hepatitis C  1  1/20443 (0.00%) 
Herpes zoster  1  1/20443 (0.00%) 
Influenza  1  1/20443 (0.00%) 
Liver abscess  1  1/20443 (0.00%) 
Lobar pneumonia  1  2/20443 (0.01%) 
Meningitis  1  1/20443 (0.00%) 
Otitis media  1  2/20443 (0.01%) 
Peritoneal tuberculosis  1  1/20443 (0.00%) 
Pneumonia  1  16/20443 (0.08%) 
Pneumonia bacterial  1  11/20443 (0.05%) 
Pneumonia fungal  1  1/20443 (0.00%) 
Postoperative wound infection  1  1/20443 (0.00%) 
Pseudomembranous colitis  1  1/20443 (0.00%) 
Pulmonary tuberculoma  1  1/20443 (0.00%) 
Pulmonary tuberculosis  1  1/20443 (0.00%) 
Pyelonephritis  1  2/20443 (0.01%) 
Pyelonephritis acute  1  1/20443 (0.00%) 
Pyometra  1  1/20443 (0.00%) 
Sepsis  1  9/20443 (0.04%) 
Septic shock  1  1/20443 (0.00%) 
Tuberculous pleurisy  1  1/20443 (0.00%) 
Urinary tract infection  1  4/20443 (0.02%) 
Injury, poisoning and procedural complications   
Accident  1  1/20443 (0.00%) 
Brain contusion  1  1/20443 (0.00%) 
Contusion  1  1/20443 (0.00%) 
Extradural haematoma  1  1/20443 (0.00%) 
Fall  1  11/20443 (0.05%) 
Femoral neck fracture  1  10/20443 (0.05%) 
Femur fracture  1  5/20443 (0.02%) 
Foot fracture  1  1/20443 (0.00%) 
Fracture  1  5/20443 (0.02%) 
Head injury  1  1/20443 (0.00%) 
Heat illness  1  1/20443 (0.00%) 
Hip fracture  1  1/20443 (0.00%) 
Humerus fracture  1  1/20443 (0.00%) 
In−stent arterial restenosis  1  1/20443 (0.00%) 
Internal injury  1  1/20443 (0.00%) 
Lower limb fracture  1  1/20443 (0.00%) 
Lumbar vertebral fracture  1  1/20443 (0.00%) 
Postoperative ileus  1  1/20443 (0.00%) 
Rib fracture  1  2/20443 (0.01%) 
Road traffic accident  1  5/20443 (0.02%) 
Shunt occlusion  1  1/20443 (0.00%) 
Spinal compression fracture  1  1/20443 (0.00%) 
Subdural haematoma  1  6/20443 (0.03%) 
Uterine rupture  1  1/20443 (0.00%) 
Wrist fracture  1  1/20443 (0.00%) 
Investigations   
Blood creatinine increased  1  2/20443 (0.01%) 
Blood pressure decreased  1  1/20443 (0.00%) 
Blood pressure increased  1  1/20443 (0.00%) 
Glucose urine present  1  1/20443 (0.00%) 
Haemoglobin decreased  1  1/20443 (0.00%) 
Protein urine present  1  1/20443 (0.00%) 
Weight increased  1  1/20443 (0.00%) 
Metabolism and nutrition disorders   
Decreased appetite  1  3/20443 (0.01%) 
Dehydration  1  3/20443 (0.01%) 
Diabetes mellitus  1  11/20443 (0.05%) 
Diabetes mellitus inadequate control  1  1/20443 (0.00%) 
Hypercholesterolaemia  1  1/20443 (0.00%) 
Hyperkalaemia  1  16/20443 (0.08%) 
Hypoglycaemia  1  2/20443 (0.01%) 
Hyponatraemia  1  1/20443 (0.00%) 
Hypophagia  1  1/20443 (0.00%) 
Marasmus  1  5/20443 (0.02%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/20443 (0.00%) 
Bursitis  1  2/20443 (0.01%) 
Cervical spinal stenosis  1  1/20443 (0.00%) 
Collagen disorder  1  1/20443 (0.00%) 
Lumbar spinal stenosis  1  1/20443 (0.00%) 
Neuropathic arthropathy  1  1/20443 (0.00%) 
Pathological fracture  1  1/20443 (0.00%) 
Rhabdomyolysis  1  1/20443 (0.00%) 
Spinal column stenosis  1  2/20443 (0.01%) 
Spinal osteoarthritis  1  1/20443 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Abdominal neoplasm  1  1/20443 (0.00%) 
Acute myeloid leukaemia  1  2/20443 (0.01%) 
Adenocarcinoma  1  1/20443 (0.00%) 
Adenocarcinoma pancreas  1  1/20443 (0.00%) 
Adult T-cell lymphoma/leukaemia  1  3/20443 (0.01%) 
Bile duct cancer  1  5/20443 (0.02%) 
Bladder cancer  1  4/20443 (0.02%) 
Bladder neoplasm  1  1/20443 (0.00%) 
Brain neoplasm  1  5/20443 (0.02%) 
Breast cancer  1  4/20443 (0.02%) 
Breast cancer recurrent  1  2/20443 (0.01%) 
Cardiac myxoma  1  1/20443 (0.00%) 
Chronic myeloid leukaemia  1  1/20443 (0.00%) 
Colon adenoma  1  1/20443 (0.00%) 
Colon cancer  1  7/20443 (0.03%) 
Gallbladder cancer  1  3/20443 (0.01%) 
Gastric cancer  1  42/20443 (0.21%) 
Gastric cancer recurrent  1  1/20443 (0.00%) 
Gastric neoplasm  1  1/20443 (0.00%) 
Hepatic cancer metastatic  1  2/20443 (0.01%) 
Hepatic neoplasm  1  3/20443 (0.01%) 
Hepatic neoplasm malignant  1  7/20443 (0.03%) 
Hepatic neoplasm malignant recurrent  1  3/20443 (0.01%) 
Hypopharyngeal cancer  1  1/20443 (0.00%) 
Large intestine carcinoma  1  26/20443 (0.13%) 
Lip and/or oral cavity cancer  1  1/20443 (0.00%) 
Liposarcoma  1  1/20443 (0.00%) 
Lung cancer metastatic  1  1/20443 (0.00%) 
Lung carcinoma cell type unspecified recurrent  1  2/20443 (0.01%) 
Lung neoplasm malignant  1  32/20443 (0.16%) 
Lymphoma  1  2/20443 (0.01%) 
Malignant ascites  1  1/20443 (0.00%) 
Malignant pleural effusion  1  1/20443 (0.00%) 
Metastases to bone  1  4/20443 (0.02%) 
Metastases to central nervous system  1  2/20443 (0.01%) 
Metastases to liver  1  1/20443 (0.00%) 
Metastases to lung  1  2/20443 (0.01%) 
Metastases to lymph nodes  1  1/20443 (0.00%) 
Metastases to meninges  1  1/20443 (0.00%) 
Metastatic neoplasm  1  1/20443 (0.00%) 
Multiple myeloma  1  1/20443 (0.00%) 
Myelodysplastic syndrome  1  1/20443 (0.00%) 
Neoplasm malignant  1  1/20443 (0.00%) 
Oesophageal carcinoma  1  8/20443 (0.04%) 
Oesophageal carcinoma recurrent  1  1/20443 (0.00%) 
Ovarian cancer  1  3/20443 (0.01%) 
Ovarian neoplasm  1  1/20443 (0.00%) 
Pancreatic carcinoma  1  11/20443 (0.05%) 
Pancreatic carcinoma recurrent  1  1/20443 (0.00%) 
Pharyngeal cancer stage unspecified  1  1/20443 (0.00%) 
Pleural mesothelioma malignant  1  1/20443 (0.00%) 
Prostate cancer  1  7/20443 (0.03%) 
Prostate cancer recurrent  1  1/20443 (0.00%) 
Rectal cancer  1  6/20443 (0.03%) 
Rectosigmoid cancer  1  2/20443 (0.01%) 
Renal cancer  1  4/20443 (0.02%) 
Retroperitoneal cancer  1  1/20443 (0.00%) 
Salivary gland adenoma  1  1/20443 (0.00%) 
Salivary gland neoplasm  1  1/20443 (0.00%) 
Thymoma malignant  1  1/20443 (0.00%) 
Thyroid cancer  1  2/20443 (0.01%) 
Ureteric cancer  1  1/20443 (0.00%) 
Nervous system disorders   
Altered state of consciousness  1  1/20443 (0.00%) 
Amnesia  1  1/20443 (0.00%) 
Amyotrophic lateral sclerosis  1  2/20443 (0.01%) 
Brain stem haemorrhage  1  2/20443 (0.01%) 
Brain stem infarction  1  1/20443 (0.00%) 
Carotid artery stenosis  1  2/20443 (0.01%) 
Cerebellar haemorrhage  1  1/20443 (0.00%) 
Cerebellar infarction  1  1/20443 (0.00%) 
Cerebral artery occlusion  1  1/20443 (0.00%) 
Cerebral haemorrhage  1  31/20443 (0.15%) 
Cerebral infarction  1  169/20443 (0.83%) 
Convulsion  1  1/20443 (0.00%) 
Dementia  1  6/20443 (0.03%) 
Dementia Alzheimer’s type  1  1/20443 (0.00%) 
Dizziness  1  3/20443 (0.01%) 
Dyskinesia  1  1/20443 (0.00%) 
Embolic stroke  1  1/20443 (0.00%) 
Hydrocephalus  1  1/20443 (0.00%) 
Hypertensive encephalopathy  1  1/20443 (0.00%) 
IIIrd nerve paralysis  1  1/20443 (0.00%) 
Intracranial aneurysm  1  1/20443 (0.00%) 
Loss of consciousness  1  2/20443 (0.01%) 
Monoplegia  1  1/20443 (0.00%) 
Myasthenia gravis  1  1/20443 (0.00%) 
Quadriplegia  1  1/20443 (0.00%) 
Subarachnoid haemorrhage  1  13/20443 (0.06%) 
Transient ischaemic attack  1  22/20443 (0.11%) 
Vertebral artery stenosis  1  1/20443 (0.00%) 
Psychiatric disorders   
Abnormal behaviour  1  1/20443 (0.00%) 
Alcoholism  1  1/20443 (0.00%) 
Completed suicide  1  2/20443 (0.01%) 
Delirium  1  1/20443 (0.00%) 
Depression  1  5/20443 (0.02%) 
Eating disorder  1  1/20443 (0.00%) 
Renal and urinary disorders   
Calculus ureteric  1  4/20443 (0.02%) 
Diabetic nephropathy  1  13/20443 (0.06%) 
Focal segmental glomerulosclerosis  1  1/20443 (0.00%) 
Glomerulonephritis chronic  1  2/20443 (0.01%) 
Hydronephrosis  1  1/20443 (0.00%) 
Lupus nephritis  1  1/20443 (0.00%) 
Mesangioproliferative glomerulonephritis  1  1/20443 (0.00%) 
Nephrolithiasis  1  1/20443 (0.00%) 
Nephropathy  1  1/20443 (0.00%) 
Nephrosclerosis  1  1/20443 (0.00%) 
Nephrotic syndrome  1  4/20443 (0.02%) 
Renal artery stenosis  1  1/20443 (0.00%) 
Renal failure  1  9/20443 (0.04%) 
Renal failure acute  1  4/20443 (0.02%) 
Renal failure chronic  1  23/20443 (0.11%) 
Renal impairment  1  6/20443 (0.03%) 
Urinary incontinence  1  1/20443 (0.00%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/20443 (0.00%) 
Endometriosis  1  1/20443 (0.00%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/20443 (0.00%) 
Acute respiratory failure  1  1/20443 (0.00%) 
Asphyxia  1  1/20443 (0.00%) 
Aspiration  1  1/20443 (0.00%) 
Asthma  1  4/20443 (0.02%) 
Caplanas syndrome  1  1/20443 (0.00%) 
Chronic respiratory failure  1  1/20443 (0.00%) 
Emphysema  1  1/20443 (0.00%) 
Haemoptysis  1  1/20443 (0.00%) 
Haemothorax  1  1/20443 (0.00%) 
Interstitial lung disease  1  9/20443 (0.04%) 
Obstructive airways disorder  1  1/20443 (0.00%) 
Organising pneumonia  1  1/20443 (0.00%) 
Pleurisy  1  1/20443 (0.00%) 
Pneumonia aspiration  1  9/20443 (0.04%) 
Pneumothorax  1  1/20443 (0.00%) 
Pulmonary alveolar haemorrhage  1  1/20443 (0.00%) 
Pulmonary embolism  1  2/20443 (0.01%) 
Pulmonary oedema  1  2/20443 (0.01%) 
Respiratory failure  1  6/20443 (0.03%) 
Sleep apnoea syndrome  1  1/20443 (0.00%) 
Surgical and medical procedures   
Aortic anastomosis  1  1/20443 (0.00%) 
Aortic valve replacement  1  2/20443 (0.01%) 
Coronary angioplasty  1  1/20443 (0.00%) 
Dialysis device insertion  1  1/20443 (0.00%) 
Orthopedic procedure  1  1/20443 (0.00%) 
Vascular graft  1  1/20443 (0.00%) 
Vascular disorders   
Aneurysm  1  1/20443 (0.00%) 
Aortic aneurysm  1  6/20443 (0.03%) 
Aortic aneurysm rupture  1  1/20443 (0.00%) 
Aortic dissection  1  5/20443 (0.02%) 
Aortic occlusion  1  1/20443 (0.00%) 
Aortic rupture  1  1/20443 (0.00%) 
Arterial occlusive disease  1  1/20443 (0.00%) 
Arterial thrombosis limb  1  1/20443 (0.00%) 
Arteriosclerosis obliterans  1  7/20443 (0.03%) 
Blood pressure inadequately controlled  1  1/20443 (0.00%) 
Deep vein thrombosis  1  2/20443 (0.01%) 
Haemorrhage  1  1/20443 (0.00%) 
Hypotension  1  2/20443 (0.01%) 
Intermittent claudication  1  2/20443 (0.01%) 
Shock  1  1/20443 (0.00%) 
Shock haemorrhagic  1  1/20443 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telmisartan
Affected / at Risk (%)
Total   0/20443 (0.00%) 
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).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00659581     History of Changes
Other Study ID Numbers: 502.511
First Submitted: April 11, 2008
First Posted: April 16, 2008
Results First Submitted: December 16, 2011
Results First Posted: March 20, 2012
Last Update Posted: August 25, 2016