Hypertension
Conditions
Brief summary
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
Interventions
DRUGtelmisartan/telmisartan + HCTZ (Hydrochlorothiazide)
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to provide written/verbal informed consent in accordance with GCP (Good Clinical Practice) and local legislation 2. Patients aged 18 \ under 80 3. Hypertension as described below: * Newly diagnosed patients with hypertension * Patients with current antihypertensive therapy
Exclusion criteria
1. Female subjects who are breastfeeding, pregnant or who plan to be pregnant during the study 2. Known or suspected secondary hypertension(e.g. pheochromocytoma) 3. Patients who have been treated with telmisartan prior to the acquisition of informed consent (including verbal informed consent)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SBP (Systolic Blood Pressure) | between baseline (visit 1) and after 12 weeks of treatment (visit 3) | The change of the mean SBP |
| Change in DBP (Diastolic Blood Pressure) | between baseline (visit 1) and after 12 weeks of treatment (visit 3) | The change of the mean DBP |
| Change in WHO-QOL (WHO-Quality Of Life) | between baseline (visit 1) and after 12 weeks of treatment (visit 3) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in VAS (Visual Analog Scale) | between baseline (visit 1) and after 12 weeks of treatment (visit 3) | VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status) |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Micardis/Micardis Plus Patients aged 18\
80 with hypertension who took Micardis/Micardis Plus | 1,025 |
| Total | 1,025 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 25 |
| Overall Study | Lost to Follow-up | 63 |
| Overall Study | Other | 28 |
| Overall Study | Protocol Violation | 10 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Micardis/Micardis Plus |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 494 Participants |
| Sex: Female, Male Male | 531 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,095 |
| serious Total, serious adverse events | 8 / — |
Outcome results
Primary
Change in DBP (Diastolic Blood Pressure)
The change of the mean DBP
Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis/Micardis Plus | Change in DBP (Diastolic Blood Pressure) | -10 mmHg | Standard Deviation 12 |
p-value: <0.0001Student Paired t-test
Primary
Change in SBP (Systolic Blood Pressure)
The change of the mean SBP
Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Population: In clinical report form (CRF), some patients' SBP was not recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis/Micardis Plus | Change in SBP (Systolic Blood Pressure) | -18 mmHg | Standard Deviation 19 |
p-value: <0.0001Student Paired t-test
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)
Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis/Micardis Plus | Change in WHO-QOL (WHO-Quality Of Life) | 2.5 Units on a scale | Standard Deviation 7.9 |
p-value: <0.0001Student Paired t-test
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)
Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis/Micardis Plus | Change in VAS (Visual Analog Scale) | 5.9 Units on a scale | Standard Deviation 14.1 |
p-value: <0.0001Student Paired t-test