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The purpose of this observational study is to survey the safety and effectiveness of the product under the real condition of usual practice in Taiwanese hypertensive patients. During the 8-week observation, the safety profiles and the clinical evaluation in between doses through blood pressure (BP) measurement for overall effectiveness of telmisartan therapy will be concluded.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving Blood Pressure (BP) Control | BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks. | 01-Dec-2006 to 31-Dec-2008 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving BP Response | Achieving BP response was defined as reduction from baseline in sitting SBP or DBP > 10 mmHg during the observational period. The observation period is 8 weeks. | 01-Dec-2006 to 31-Dec-2008 |
| Overall Assessment by Patients |
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Inclusion Criteria:
1. Male or female. 2. Aged 20 to 80 years old. 3. Patients meet one of following two criteria:
Exclusion Criteria:
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Hypertension patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigator Site | Changhua | Taiwan | ||||
| Boehringer Ingelheim Investigator Site 1 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertension Patients | Telmisartan 40mg or 80 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Overall assessment was reported as a 5-point scale rated from 0 to 4 as below: 4: Outstanding 3: Very satisfactory 2: Satisfactory 1: Marginal 0: Not satisfactory |
| 01-Dec-2006 to 31-Dec-2008 |
| Overall Assessment by Attending Physicians | Overall assessment was reported as a 5-point scale rated from 0 to 4 as below: 4: Outstanding 3: Very satisfactory 2: Satisfactory 1: Marginal 0: Not satisfactory | 01-Dec-2006 to 31-Dec-2008 |
| Chiayi City |
| Taiwan |
| Boehringer Ingelheim Investigator Site 2 | Chiayi City | Taiwan |
| Boehringer Ingelheim Investigator Site | Keelung | Taiwan |
| Boehringer Ingelheim Investigator Site | Ksohsiung | Taiwan |
| Boehringer Ingelheim Investigator Site | Miaoli | Taiwan |
| Boehringer Ingelheim Investigator Site 1 | Taichung | Taiwan |
| Boehringer Ingelheim Investigator Site 2 | Taichung | Taiwan |
| Boehringer Ingelheim Investigator Site 1 | Tainan | Taiwan |
| Boehringer Ingelheim Investigator Site 2 | Tainan | Taiwan |
| Boehringer Ingelheim Investigator Site 1 | Taipei | Taiwan |
| Boehringer Ingelheim Investigator Site 2 | Taipei | Taiwan |
| Boehringer Ingelheim Investigator Site 3 | Taipei | Taiwan |
| Boehringer Ingelheim Investigator Site 4 | Taipei | Taiwan |
| Boehringer Ingelheim Investigator Site 5 | Taipei | Taiwan |
| Boehringer Ingelheim Investigator Site 6 | Taipei | Taiwan |
| Boehringer Ingelheim Investigator Site 7 | Taipei | Taiwan |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypertension Patients | Telmisartan 40mg or 80 mg |
| 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 | Percentage of Patients Achieving Blood Pressure (BP) Control | BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks. | Subjects include those who took 20mg, 40mg, 80mg and unknown dosage | Posted | Number | Percentage of Participants | 01-Dec-2006 to 31-Dec-2008 |
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| Secondary | Percentage of Patients Achieving BP Response | Achieving BP response was defined as reduction from baseline in sitting SBP or DBP > 10 mmHg during the observational period. The observation period is 8 weeks. | Included the patients who took 20mg, 40mg, 80mg and unknown dosage. | Posted | Number | percentage of participants | 01-Dec-2006 to 31-Dec-2008 |
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| Secondary | Overall Assessment by Patients | Overall assessment was reported as a 5-point scale rated from 0 to 4 as below: 4: Outstanding 3: Very satisfactory 2: Satisfactory 1: Marginal 0: Not satisfactory | Included the patients who took 20mg, 40mg, 80mg and unknown dosage. | Posted | Number | Percentage of Participants | 01-Dec-2006 to 31-Dec-2008 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Assessment by Attending Physicians | Overall assessment was reported as a 5-point scale rated from 0 to 4 as below: 4: Outstanding 3: Very satisfactory 2: Satisfactory 1: Marginal 0: Not satisfactory | Included the patients who took 20mg, 40mg, 80mg and unknown dosage | Posted | Number | Percentage of Participants | 01-Dec-2006 to 31-Dec-2008 |
|
|
8 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypertension Patients | Telmisartan 40mg or 80 mg | 16 | 3,148 | 0 | 3,148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Dizziness, Dizzling | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Tendon rupture | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Ischaemic cerebral infarction | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| Ileal ulcer perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Peritonitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Septic shock | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypovolemic shock | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Sudden cardiac death | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Subdural haematoma | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| Subarachnoid haemorrhage | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| Skull fracture | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
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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 |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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