Hypertension
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1\. Male or female. 2. Aged 20 to 80 years old. 3. Patients meet one of following two criteria: 1. Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic blood pressure (BP) \> 140 mmHg but \< 180 mmHg, and/or diastolic BP \> 90 mmHg but \< 110 mmHg). 2. Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.
Exclusion criteria
1. Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert). 2. Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets. 3. Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving Blood Pressure (BP) Control | 01-Dec-2006 to 31-Dec-2008 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving BP Response | 01-Dec-2006 to 31-Dec-2008 | 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. |
| Overall Assessment by Patients | 01-Dec-2006 to 31-Dec-2008 | 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 |
| Overall Assessment by Attending Physicians | 01-Dec-2006 to 31-Dec-2008 | 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 |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypertension Patients Telmisartan 40mg or 80 mg | 3,148 |
| Total | 3,148 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 122 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Other | 370 |
Baseline characteristics
| Characteristic | Hypertension Patients |
|---|---|
| Age, Continuous | 61.04 Years STANDARD_DEVIATION 12.36 |
| Sex: Female, Male Female | 1525 Participants |
| Sex: Female, Male Male | 1623 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3,148 |
| serious Total, serious adverse events | 16 / 3,148 |
Outcome results
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.
Time frame: 01-Dec-2006 to 31-Dec-2008
Population: Subjects include those who took 20mg, 40mg, 80mg and unknown dosage
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Micardis 40mg | Percentage of Patients Achieving Blood Pressure (BP) Control | 66 Percentage of Participants |
| Micardis 80mg | Percentage of Patients Achieving Blood Pressure (BP) Control | 46 Percentage of Participants |
| Total | Percentage of Patients Achieving Blood Pressure (BP) Control | 65 Percentage of Participants |
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
Time frame: 01-Dec-2006 to 31-Dec-2008
Population: Included the patients who took 20mg, 40mg, 80mg and unknown dosage
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis 40mg | Overall Assessment by Attending Physicians | Marginal | 9 Percentage of Participants |
| Micardis 40mg | Overall Assessment by Attending Physicians | Satisfactory | 45 Percentage of Participants |
| Micardis 40mg | Overall Assessment by Attending Physicians | Outstanding | 10 Percentage of Participants |
| Micardis 40mg | Overall Assessment by Attending Physicians | Very satisfactory | 34 Percentage of Participants |
| Micardis 40mg | Overall Assessment by Attending Physicians | Not satisfactory | 3 Percentage of Participants |
| Micardis 80mg | Overall Assessment by Attending Physicians | Satisfactory | 38 Percentage of Participants |
| Micardis 80mg | Overall Assessment by Attending Physicians | Outstanding | 6 Percentage of Participants |
| Micardis 80mg | Overall Assessment by Attending Physicians | Very satisfactory | 24 Percentage of Participants |
| Micardis 80mg | Overall Assessment by Attending Physicians | Marginal | 22 Percentage of Participants |
| Micardis 80mg | Overall Assessment by Attending Physicians | Not satisfactory | 11 Percentage of Participants |
| Total | Overall Assessment by Attending Physicians | Not satisfactory | 4 Percentage of Participants |
| Total | Overall Assessment by Attending Physicians | Marginal | 10 Percentage of Participants |
| Total | Overall Assessment by Attending Physicians | Outstanding | 9 Percentage of Participants |
| Total | Overall Assessment by Attending Physicians | Satisfactory | 44 Percentage of Participants |
| Total | Overall Assessment by Attending Physicians | Very satisfactory | 33 Percentage of Participants |
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
Time frame: 01-Dec-2006 to 31-Dec-2008
Population: Included the patients who took 20mg, 40mg, 80mg and unknown dosage.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis 40mg | Overall Assessment by Patients | Marginal | 9 Percentage of Participants |
| Micardis 40mg | Overall Assessment by Patients | Satisfatory | 47 Percentage of Participants |
| Micardis 40mg | Overall Assessment by Patients | Outstanding | 8 Percentage of Participants |
| Micardis 40mg | Overall Assessment by Patients | Very satisfactory | 34 Percentage of Participants |
| Micardis 40mg | Overall Assessment by Patients | Not satisfactory | 2 Percentage of Participants |
| Micardis 80mg | Overall Assessment by Patients | Satisfatory | 43 Percentage of Participants |
| Micardis 80mg | Overall Assessment by Patients | Outstanding | 14 Percentage of Participants |
| Micardis 80mg | Overall Assessment by Patients | Very satisfactory | 25 Percentage of Participants |
| Micardis 80mg | Overall Assessment by Patients | Marginal | 18 Percentage of Participants |
| Micardis 80mg | Overall Assessment by Patients | Not satisfactory | 8 Percentage of Participants |
| Total | Overall Assessment by Patients | Not satisfactory | 3 Percentage of Participants |
| Total | Overall Assessment by Patients | Marginal | 10 Percentage of Participants |
| Total | Overall Assessment by Patients | Outstanding | 8 Percentage of Participants |
| Total | Overall Assessment by Patients | Satisfatory | 47 Percentage of Participants |
| Total | Overall Assessment by Patients | Very satisfactory | 33 Percentage of Participants |
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.
Time frame: 01-Dec-2006 to 31-Dec-2008
Population: Included the patients who took 20mg, 40mg, 80mg and unknown dosage.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis 40mg | Percentage of Patients Achieving BP Response | Achieving SBP > 10 mmHg | 63 percentage of participants |
| Micardis 40mg | Percentage of Patients Achieving BP Response | Achieving DBP > 10 mmHg | 40 percentage of participants |
| Micardis 80mg | Percentage of Patients Achieving BP Response | Achieving SBP > 10 mmHg | 63 percentage of participants |
| Micardis 80mg | Percentage of Patients Achieving BP Response | Achieving DBP > 10 mmHg | 31 percentage of participants |
| Total | Percentage of Patients Achieving BP Response | Achieving SBP > 10 mmHg | 63 percentage of participants |
| Total | Percentage of Patients Achieving BP Response | Achieving DBP > 10 mmHg | 39 percentage of participants |