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This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:
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| Measure | Description | Time Frame |
|---|---|---|
| Unexpected Adverse Events | Occurrence status of unexpected adverse events | Up to 6 years |
| Frequency of Adverse Events | Up to 6 years | |
| Change From Baseline in SBP (Systolic Blood Pressure) at Week 2 | Effect on decrease in systolic blood pressure | Baseline and End of Study |
| Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 | Effect on decrease in diastolic blood pressure | Baseline and End of Study |
| Effective Rate | Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows: â… . Effective (if the clinical judgement of investigator is 1 or 2=cured or improved) â…¡. Not effective (if the clinical judgement of investigator is 3=failed) | Baseline and End of Study |
| Measure | Description | Time Frame |
|---|---|---|
| Gender Factors Affecting the Safety Profile | Occurrence status of adverse events by Gender category of patients | Up to 6 years |
| Age Factors Affecting the Safety Profile | Occurrence status of adverse events by Age category of patients |
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Inclusion Criteria:
patients diagnosed with essential hypertension
Exclusion Criteria:
patients who took Micardis Plus before participating in this PMS study
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Hospitals and clinics 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 10 | Busan | South Korea | ||||
| Boehringer Ingelheim Investigational Site 11 |
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A total of 6,901 Case Report Forms were retrieved from 281 study centers. Three thousand and nine hundred thirty two (3,932) patients were eligible for the safety assessment. As requested by KFDA to be in line with the registered indication, 2, 969 patients with mild hypertension and treatment naïve patients were excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertensive Patients With Micardis Plus for the First Time | In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Up to 6 years |
| Proportion of Geriatric Population Factor Affecting the Safety Profile | Occurrence status of adverse events by Proportion of geriatric population of patients | Up to 6 years |
| Treatment Type Factors Affecting the Safety Profile | Occurrence status of adverse events by Treatment type of patients | Up to 6 years |
| Medical History Factors Affecting the Safety Profile | Occurrence status of adverse events by medical history of patients | Up to 6 years |
| Concomitant Disease Factors Affecting the Safety Profile | Occurrence status of adverse events by Concomitant disease of patients | Up to 6 years |
| Medical History Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients | Baseline and End of Study |
| Previous Medication Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients | Baseline and End of Study |
| Baseline Severity of Hypertension Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients Stage 1 (SBP 140~159 mmHg or DBP 90~99 mmHg) Stage 2 (SBP 160~179 mmHg or DBP 100~109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg) | Baseline and End of Study |
| Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients 40/12.5mg < daily dose < 80/12.5mg - Because some physicians changed the daily dose based on patient's BP control result, this range exists | Baseline and End of Study |
| Busan |
| South Korea |
| Boehringer Ingelheim Investigational Site 12 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 13 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 14 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 15 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 16 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 17 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 18 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 19 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 20 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 21 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 22 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 23 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 24 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 25 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 26 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 27 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 28 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 29 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 30 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 31 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 32 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 33 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 34 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 35 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 36 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 37 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 38 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 39 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 3 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 40 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 41 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 42 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 43 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 44 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 45 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 46 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 47 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 48 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 49 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 4 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 5 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 6 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 7 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 8 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 9 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 10 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 11 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 12 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 13 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 14 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 15 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 16 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 17 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 18 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 19 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 20 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 21 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 22 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 23 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 24 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 25 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 26 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 27 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 3 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 4 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 5 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 6 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 7 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 8 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 9 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 10 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 11 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 12 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 13 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 14 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 15 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 16 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 17 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 18 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 19 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 20 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 21 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 22 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 23 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 24 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 25 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 26 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 27 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 28 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 29 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 30 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 31 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 3 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 4 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 5 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 6 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 7 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 8 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 9 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 10 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 11 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 12 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 13 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 3 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 4 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 5 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 6 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 7 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 8 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 9 | Gangwondo | South Korea |
| Boehringer Ingelheim Investigational Site 10 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 11 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 12 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 13 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 14 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 15 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 16 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 17 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 18 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 19 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 20 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 21 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 22 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 23 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 24 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 25 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 26 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 27 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 28 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 29 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 30 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 31 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 32 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 33 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 34 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 35 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 36 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 37 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 38 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 39 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 3 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 40 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 41 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 42 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 43 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 4 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 5 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 6 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 7 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 8 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 9 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site | Gyeongbuk | South Korea |
| Boehringer Ingelheim Investigational Site 10 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 11 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 12 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 13 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 14 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 15 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 16 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 17 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 18 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 19 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 20 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 21 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 22 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 23 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 24 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 25 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 26 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 27 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 28 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 29 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 30 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 31 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 32 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 33 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 34 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 35 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 36 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 37 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 38 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 39 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 3 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 40 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 41 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 42 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 43 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 44 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 45 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 46 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 47 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 48 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 49 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 4 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 50 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 51 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 52 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 53 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 54 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 55 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 56 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 57 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 58 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 59 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 5 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 60 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 61 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 62 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 63 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 64 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 65 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 66 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 67 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 68 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 69 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 6 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 70 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 71 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 7 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 8 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site 9 | Gyeonggido | South Korea |
| Boehringer Ingelheim Investigational Site | Gyeongnam | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 3 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 4 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 5 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 6 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 7 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 8 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 9 | Incheon | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Jeju City | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Jeju City | South Korea |
| Boehringer Ingelheim Investigational Site | Jeonbuk | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Jeonnam | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Jeonnam | South Korea |
| Boehringer Ingelheim Investigational Site 3 | Jeonnam | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Jungnam | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Jungnam | South Korea |
| Boehringer Ingelheim Investigational Site 10 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 11 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 12 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 13 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 14 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 15 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 16 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 17 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 18 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 19 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 1 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 20 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 21 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 22 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 23 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 24 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 25 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 26 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 27 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 28 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 29 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 2 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 30 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 31 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 32 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 33 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 34 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 35 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 36 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 37 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 38 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 39 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 3 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 40 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 41 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 42 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 43 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 44 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 45 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 46 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 47 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 48 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 49 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 4 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 50 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 51 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 52 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 53 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 54 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 55 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 56 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 57 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 58 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 59 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 5 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 60 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 61 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 62 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 63 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 64 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 65 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 66 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 67 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 68 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 69 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 6 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 70 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 71 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 72 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 73 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 7 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 8 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 9 | Seoul | South Korea |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hypertensive Patients With Micardis Plus for the First Time | In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Date of birth not recorded for 15 patients, | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Gender not recorded for 15 patients | 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 | Unexpected Adverse Events | Occurrence status of unexpected adverse events | Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment | Posted | Number | Percentage of patients | Up to 6 years |
|
|
| ||||||||||||||||||||||||||
| Primary | Frequency of Adverse Events | Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment | Posted | Number | Percentage of patients | Up to 6 years |
|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in SBP (Systolic Blood Pressure) at Week 2 | Effect on decrease in systolic blood pressure | Out of 6,901 patients, 3,616 patients for the efficacy assessment | Posted | Mean | Standard Deviation | mmHg | Baseline and End of Study |
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| Secondary | Gender Factors Affecting the Safety Profile | Occurrence status of adverse events by Gender category of patients | Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Gender not recorded for 15 patients | Posted | Number | 95% Confidence Interval | Percentage of patients | Up to 6 years |
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| Secondary | Age Factors Affecting the Safety Profile | Occurrence status of adverse events by Age category of patients | Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients | Posted | Number | 95% Confidence Interval | Percentage of patients | Up to 6 years |
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| Secondary | Proportion of Geriatric Population Factor Affecting the Safety Profile | Occurrence status of adverse events by Proportion of geriatric population of patients | Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients | Posted | Number | 95% Confidence Interval | Percentage of patients | Up to 6 years |
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| Secondary | Treatment Type Factors Affecting the Safety Profile | Occurrence status of adverse events by Treatment type of patients | Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Treatment type not recorded for 294 patients | Posted | Number | 95% Confidence Interval | Percentage of patients | Up to 6 years |
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| Primary | Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 | Effect on decrease in diastolic blood pressure | Out of 6,901 patients, 3,616 patients for the efficacy assessment | Posted | Mean | Standard Deviation | mmHg | Baseline and End of Study |
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| Primary | Effective Rate | Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows: â… . Effective (if the clinical judgement of investigator is 1 or 2=cured or improved) â…¡. Not effective (if the clinical judgement of investigator is 3=failed) | Out of 6,901 patients, 3,616 patients for the efficacy assessment | Posted | Number | Percentage of patients | Baseline and End of Study |
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| Secondary | Medical History Factors Affecting the Safety Profile | Occurrence status of adverse events by medical history of patients | Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment | Posted | Number | 95% Confidence Interval | Percentage of patients | Up to 6 years |
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| Secondary | Concomitant Disease Factors Affecting the Safety Profile | Occurrence status of adverse events by Concomitant disease of patients | Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment | Posted | Number | 95% Confidence Interval | Percentage of patients | Up to 6 years |
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| Secondary | Medical History Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients | Out of 6,901 patients, 3,616 patients for the efficacy assessment | Posted | Number | Percentage of patients | Baseline and End of Study |
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| Secondary | Previous Medication Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients | Out of 6,901 patients, 3,616 patients for the efficacy assessment | Posted | Number | Percentage of patients | Baseline and End of Study |
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| Secondary | Baseline Severity of Hypertension Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients Stage 1 (SBP 140~159 mmHg or DBP 90~99 mmHg) Stage 2 (SBP 160~179 mmHg or DBP 100~109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg) | Out of 6,901 patients, 3,616 patients for the efficacy assessment | Posted | Number | Percentage of patients | Baseline and End of Study |
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| Secondary | Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile | Efficacy rate by medical characteristic of patients 40/12.5mg < daily dose < 80/12.5mg - Because some physicians changed the daily dose based on patient's BP control result, this range exists | Out of 6,901 patients, 3,616 patients for the efficacy assessment and Daily dose not recorded for 26 patients | Posted | Number | Percentage of patients | Baseline and End of Study |
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Over a period of 6 years
The number of patients for safety assessment is 3932.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypertensive Patients With Micardis Plus for the First Time | In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616. | 1 | 3,932 | 0 | 3,932 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | WHO-ART 2006 | Systematic Assessment |
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Not provided
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 |
Not provided
Not provided
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