Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension
- Conditions
- Hypertension
- Registration Number
- NCT00659607
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:
1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs))
2. Frequency of incidence and its change in adverse events (AEs)
3. Factors on the safety profile of the study drug
4. Factors on the efficacy profile of the study drug
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6901
patients diagnosed with essential hypertension
patients who took Micardis Plus before participating in this PMS study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Unexpected Adverse Events Up to 6 years Occurrence status of unexpected adverse events
Frequency of Adverse Events Up to 6 years Change From Baseline in SBP (Systolic Blood Pressure) at Week 2 Baseline and End of Study Effect on decrease in systolic blood pressure
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 Baseline and End of Study Effect on decrease in diastolic blood pressure
Effective Rate Baseline and End of Study Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows:
Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved)
Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed)
- Secondary Outcome Measures
Name Time Method Gender Factors Affecting the Safety Profile Up to 6 years Occurrence status of adverse events by Gender category of patients
Age Factors Affecting the Safety Profile Up to 6 years Occurrence status of adverse events by Age category of patients
Proportion of Geriatric Population Factor Affecting the Safety Profile Up to 6 years Occurrence status of adverse events by Proportion of geriatric population of patients
Treatment Type Factors Affecting the Safety Profile Up to 6 years Occurrence status of adverse events by Treatment type of patients
Medical History Factors Affecting the Safety Profile Up to 6 years Occurrence status of adverse events by medical history of patients
Concomitant Disease Factors Affecting the Safety Profile Up to 6 years Occurrence status of adverse events by Concomitant disease of patients
Medical History Factors Affecting the Efficacy Profile Baseline and End of Study Efficacy rate by medical characteristic of patients
Previous Medication Factors Affecting the Efficacy Profile Baseline and End of Study Efficacy rate by medical characteristic of patients
Baseline Severity of Hypertension Factors Affecting the Efficacy Profile Baseline and End of Study 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)Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile Baseline and End of Study 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
Trial Locations
- Locations (74)
Boehringer Ingelheim Investigational Site 14
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 15
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 12
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 16
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 18
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 11
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 17
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Boehringer Ingelheim Investigational Site 13
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Boehringer Ingelheim Investigational Site 10
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 5
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Boehringer Ingelheim Investigational Site 20
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 23
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Boehringer Ingelheim Investigational Site 27
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Boehringer Ingelheim Investigational Site 35
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Boehringer Ingelheim Investigational Site 3
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Boehringer Ingelheim Investigational Site 45
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Boehringer Ingelheim Investigational Site 48
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Boehringer Ingelheim Investigational Site 4
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Boehringer Ingelheim Investigational Site 46
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Boehringer Ingelheim Investigational Site 19
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Boehringer Ingelheim Investigational Site 33
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Boehringer Ingelheim Investigational Site 36
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Boehringer Ingelheim Investigational Site 9
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Boehringer Ingelheim Investigational Site 54
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Boehringer Ingelheim Investigational Site 41
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Boehringer Ingelheim Investigational Site 1
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Boehringer Ingelheim Investigational Site 29
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Boehringer Ingelheim Investigational Site 2
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Boehringer Ingelheim Investigational Site 34
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Boehringer Ingelheim Investigational Site 44
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Boehringer Ingelheim Investigational Site 7
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Boehringer Ingelheim Investigational Site 63
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Boehringer Ingelheim Investigational Site 69
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Boehringer Ingelheim Investigational Site 43
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site
🇰🇷Jeonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 47
🇰🇷Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 6
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Boehringer Ingelheim Investigational Site 52
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Boehringer Ingelheim Investigational Site 49
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Boehringer Ingelheim Investigational Site 57
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Boehringer Ingelheim Investigational Site 66
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Boehringer Ingelheim Investigational Site 30
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Boehringer Ingelheim Investigational Site 40
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Boehringer Ingelheim Investigational Site 50
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Boehringer Ingelheim Investigational Site 56
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Boehringer Ingelheim Investigational Site 58
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Boehringer Ingelheim Investigational Site 73
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Boehringer Ingelheim Investigational Site 8
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Boehringer Ingelheim Investigational Site 68
🇰🇷Seoul, Korea, Republic of