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An observational study to investigate the efficacy, safety, tolerability and the effect on quality of life of Telmisartan (Micardis) and Telmisartan with HCTZ (Micardis Plus) in patients with hypertension
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan/telmisartan + HCTZ (Hydrochlorothiazide) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SBP (Systolic Blood Pressure) | The change of the mean SBP | between baseline (visit 1) and after 12 weeks of treatment (visit 3) |
| Change in DBP (Diastolic Blood Pressure) | The change of the mean DBP | between baseline (visit 1) and after 12 weeks of treatment (visit 3) |
| Change in WHO-QOL (WHO-Quality Of Life) | World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed. Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life) | between baseline (visit 1) and after 12 weeks of treatment (visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VAS (Visual Analog Scale) | VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status) | between baseline (visit 1) and after 12 weeks of treatment (visit 3) |
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Inclusion Criteria:
Ability to provide written/verbal informed consent in accordance with GCP (Good Clinical Practice) and local legislation
Patients aged 18 ~ under 80
Hypertension as described below:
Exclusion Criteria:
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Patients from clinics and hospitals in Korea
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer ingelheim Investigational Site 1 | Daegu | South Korea | ||||
| Boehringer ingelheim Investigational Site 4 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Micardis/Micardis Plus | Patients aged 18~80 with hypertension who took Micardis/Micardis Plus |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Daegu |
| South Korea |
| Boehringer ingelheim Investigational Site 7 | Daegu | South Korea |
| Boehringer ingelheim Investigational Site 9 | Daejeon | South Korea |
| Boehringer ingelheim Investigational Site 10 | Koyang | South Korea |
| Boehringer ingelheim Investigational Site 11 | Kwangju | South Korea |
| Boehringer ingelheim Investigational Site 3 | Kwangju | South Korea |
| Boehringer ingelheim Investigational Site 5 | Pusan | South Korea |
| Boehringer ingelheim Investigational Site 2 | Seoul | South Korea |
| Boehringer ingelheim Investigational Site 6 | Suwon | South Korea |
| Boehringer ingelheim Investigational Site 8 | Wŏnju | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Micardis/Micardis Plus | Patients aged 18~80 with hypertension who took Micardis/Micardis Plus |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in SBP (Systolic Blood Pressure) | The change of the mean SBP | In clinical report form (CRF), some patients' SBP was not recorded. | Posted | Mean | Standard Deviation | mmHg | between baseline (visit 1) and after 12 weeks of treatment (visit 3) |
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| Primary | Change in DBP (Diastolic Blood Pressure) | The change of the mean DBP | Posted | Mean | Standard Deviation | mmHg | between baseline (visit 1) and after 12 weeks of treatment (visit 3) |
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| Secondary | Change in VAS (Visual Analog Scale) | VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status) | Posted | Mean | Standard Deviation | Units on a scale | between baseline (visit 1) and after 12 weeks of treatment (visit 3) |
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| Primary | Change in WHO-QOL (WHO-Quality Of Life) | World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed. Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life) | Posted | Mean | Standard Deviation | Units on a scale | between baseline (visit 1) and after 12 weeks of treatment (visit 3) |
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After signing informed consent through the end of study
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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 | Micardis/Micardis Plus | Patients aged 18~80 with hypertension who took Micardis/Micardis Plus | 8 | 0 | 1,095 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral infarction | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Gastric polyps | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Varices oesophageal | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | 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 Pharmaceuticals | 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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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
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