HypertensionNCT00659607
Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension
An observational study of Hypertension, run by Boehringer Ingelheim at 326 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 6,901 participants
- Where
- 326 sitesSouth Korea
- Study dates
- Sep 2003to Jul 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitals and clinics in Korea
Who may be able to join
- patients diagnosed with essential hypertension
Who cannot join
- patients who took Micardis Plus before participating in this PMS study
Trial locations and contacts
326 sites in 1 country.
300 sites in 1 country
South Korea300 sites
Boehringer Ingelheim Investigational Site 10
Busan
Boehringer Ingelheim Investigational Site 11
Busan
Boehringer Ingelheim Investigational Site 12
Busan
Boehringer Ingelheim Investigational Site 13
Busan
Boehringer Ingelheim Investigational Site 14
Busan
Boehringer Ingelheim Investigational Site 15
Busan
Boehringer Ingelheim Investigational Site 16
Busan
Boehringer Ingelheim Investigational Site 17
Busan
Boehringer Ingelheim Investigational Site 18
Busan
Boehringer Ingelheim Investigational Site 19
Busan
Boehringer Ingelheim Investigational Site 1
Busan
Boehringer Ingelheim Investigational Site 20
Busan
Boehringer Ingelheim Investigational Site 21
Busan
Boehringer Ingelheim Investigational Site 22
Busan
Boehringer Ingelheim Investigational Site 23
Busan
Boehringer Ingelheim Investigational Site 24
Busan
Boehringer Ingelheim Investigational Site 25
Busan
Boehringer Ingelheim Investigational Site 26
Busan
Boehringer Ingelheim Investigational Site 27
Busan
Boehringer Ingelheim Investigational Site 28
Busan
Boehringer Ingelheim Investigational Site 29
Busan
Boehringer Ingelheim Investigational Site 2
Busan
Boehringer Ingelheim Investigational Site 30
Busan
Boehringer Ingelheim Investigational Site 31
Busan
Boehringer Ingelheim Investigational Site 32
Busan
Boehringer Ingelheim Investigational Site 33
Busan
Boehringer Ingelheim Investigational Site 34
Busan
Boehringer Ingelheim Investigational Site 35
Busan
Boehringer Ingelheim Investigational Site 36
Busan
Boehringer Ingelheim Investigational Site 37
Busan
Boehringer Ingelheim Investigational Site 38
Busan
Boehringer Ingelheim Investigational Site 39
Busan
Boehringer Ingelheim Investigational Site 3
Busan
Boehringer Ingelheim Investigational Site 40
Busan
Boehringer Ingelheim Investigational Site 41
Busan
Boehringer Ingelheim Investigational Site 42
Busan
Boehringer Ingelheim Investigational Site 43
Busan
Boehringer Ingelheim Investigational Site 44
Busan
Boehringer Ingelheim Investigational Site 45
Busan
Boehringer Ingelheim Investigational Site 46
Busan
Boehringer Ingelheim Investigational Site 47
Busan
Boehringer Ingelheim Investigational Site 48
Busan
Boehringer Ingelheim Investigational Site 49
Busan
Boehringer Ingelheim Investigational Site 4
Busan
Boehringer Ingelheim Investigational Site 5
Busan
Boehringer Ingelheim Investigational Site 6
Busan
Boehringer Ingelheim Investigational Site 7
Busan
Boehringer Ingelheim Investigational Site 8
Busan
Boehringer Ingelheim Investigational Site 9
Busan
Boehringer Ingelheim Investigational Site 10
Daegu
Boehringer Ingelheim Investigational Site 11
Daegu
Boehringer Ingelheim Investigational Site 12
Daegu
Boehringer Ingelheim Investigational Site 13
Daegu
Boehringer Ingelheim Investigational Site 14
Daegu
Boehringer Ingelheim Investigational Site 15
Daegu
Boehringer Ingelheim Investigational Site 16
Daegu
Boehringer Ingelheim Investigational Site 17
Daegu
Boehringer Ingelheim Investigational Site 18
Daegu
Boehringer Ingelheim Investigational Site 19
Daegu
Boehringer Ingelheim Investigational Site 1
Daegu
Boehringer Ingelheim Investigational Site 20
Daegu
Boehringer Ingelheim Investigational Site 21
Daegu
Boehringer Ingelheim Investigational Site 22
Daegu
Boehringer Ingelheim Investigational Site 23
Daegu
Boehringer Ingelheim Investigational Site 24
Daegu
Boehringer Ingelheim Investigational Site 25
Daegu
Boehringer Ingelheim Investigational Site 26
Daegu
Boehringer Ingelheim Investigational Site 27
Daegu
Boehringer Ingelheim Investigational Site 2
Daegu
Boehringer Ingelheim Investigational Site 3
Daegu
Boehringer Ingelheim Investigational Site 4
Daegu
Boehringer Ingelheim Investigational Site 5
Daegu
Boehringer Ingelheim Investigational Site 6
Daegu
Boehringer Ingelheim Investigational Site 7
Daegu
Boehringer Ingelheim Investigational Site 8
Daegu
Boehringer Ingelheim Investigational Site 9
Daegu
Boehringer Ingelheim Investigational Site 10
Daejeon
Boehringer Ingelheim Investigational Site 11
Daejeon
Boehringer Ingelheim Investigational Site 12
Daejeon
Boehringer Ingelheim Investigational Site 13
Daejeon
Boehringer Ingelheim Investigational Site 14
Daejeon
Boehringer Ingelheim Investigational Site 15
Daejeon
Boehringer Ingelheim Investigational Site 16
Daejeon
Boehringer Ingelheim Investigational Site 17
Daejeon
Boehringer Ingelheim Investigational Site 18
Daejeon
Boehringer Ingelheim Investigational Site 19
Daejeon
Boehringer Ingelheim Investigational Site 1
Daejeon
Boehringer Ingelheim Investigational Site 20
Daejeon
Boehringer Ingelheim Investigational Site 21
Daejeon
Boehringer Ingelheim Investigational Site 22
Daejeon
Boehringer Ingelheim Investigational Site 23
Daejeon
Boehringer Ingelheim Investigational Site 24
Daejeon
Boehringer Ingelheim Investigational Site 25
Daejeon
Boehringer Ingelheim Investigational Site 26
Daejeon
Boehringer Ingelheim Investigational Site 27
Daejeon
Boehringer Ingelheim Investigational Site 28
Daejeon
Boehringer Ingelheim Investigational Site 29
Daejeon
Boehringer Ingelheim Investigational Site 2
Daejeon
Boehringer Ingelheim Investigational Site 30
Daejeon
Boehringer Ingelheim Investigational Site 31
Daejeon
Boehringer Ingelheim Investigational Site 3
Daejeon
Boehringer Ingelheim Investigational Site 4
Daejeon
Boehringer Ingelheim Investigational Site 5
Daejeon
Boehringer Ingelheim Investigational Site 6
Daejeon
Boehringer Ingelheim Investigational Site 7
Daejeon
Boehringer Ingelheim Investigational Site 8
Daejeon
Boehringer Ingelheim Investigational Site 9
Daejeon
Boehringer Ingelheim Investigational Site 10
Gangwondo
Boehringer Ingelheim Investigational Site 11
Gangwondo
Boehringer Ingelheim Investigational Site 12
Gangwondo
Boehringer Ingelheim Investigational Site 13
Gangwondo
Boehringer Ingelheim Investigational Site 1
Gangwondo
Boehringer Ingelheim Investigational Site 2
Gangwondo
Boehringer Ingelheim Investigational Site 3
Gangwondo
Boehringer Ingelheim Investigational Site 4
Gangwondo
Boehringer Ingelheim Investigational Site 5
Gangwondo
Boehringer Ingelheim Investigational Site 6
Gangwondo
Boehringer Ingelheim Investigational Site 7
Gangwondo
Boehringer Ingelheim Investigational Site 8
Gangwondo
Boehringer Ingelheim Investigational Site 9
Gangwondo
Boehringer Ingelheim Investigational Site 10
Gwangju
Boehringer Ingelheim Investigational Site 11
Gwangju
Boehringer Ingelheim Investigational Site 12
Gwangju
Boehringer Ingelheim Investigational Site 13
Gwangju
Boehringer Ingelheim Investigational Site 14
Gwangju
Boehringer Ingelheim Investigational Site 15
Gwangju
Boehringer Ingelheim Investigational Site 16
Gwangju
Boehringer Ingelheim Investigational Site 17
Gwangju
Boehringer Ingelheim Investigational Site 18
Gwangju
Boehringer Ingelheim Investigational Site 19
Gwangju
Boehringer Ingelheim Investigational Site 1
Gwangju
Boehringer Ingelheim Investigational Site 20
Gwangju
Boehringer Ingelheim Investigational Site 21
Gwangju
Boehringer Ingelheim Investigational Site 22
Gwangju
Boehringer Ingelheim Investigational Site 23
Gwangju
Boehringer Ingelheim Investigational Site 24
Gwangju
Boehringer Ingelheim Investigational Site 25
Gwangju
Boehringer Ingelheim Investigational Site 26
Gwangju
Boehringer Ingelheim Investigational Site 27
Gwangju
Boehringer Ingelheim Investigational Site 28
Gwangju
Boehringer Ingelheim Investigational Site 29
Gwangju
Boehringer Ingelheim Investigational Site 2
Gwangju
Boehringer Ingelheim Investigational Site 30
Gwangju
Boehringer Ingelheim Investigational Site 31
Gwangju
Boehringer Ingelheim Investigational Site 32
Gwangju
Boehringer Ingelheim Investigational Site 33
Gwangju
Boehringer Ingelheim Investigational Site 34
Gwangju
Boehringer Ingelheim Investigational Site 35
Gwangju
Boehringer Ingelheim Investigational Site 36
Gwangju
Boehringer Ingelheim Investigational Site 37
Gwangju
Boehringer Ingelheim Investigational Site 38
Gwangju
Boehringer Ingelheim Investigational Site 39
Gwangju
Boehringer Ingelheim Investigational Site 3
Gwangju
Boehringer Ingelheim Investigational Site 40
Gwangju
Boehringer Ingelheim Investigational Site 41
Gwangju
Boehringer Ingelheim Investigational Site 42
Gwangju
Boehringer Ingelheim Investigational Site 43
Gwangju
Boehringer Ingelheim Investigational Site 4
Gwangju
Boehringer Ingelheim Investigational Site 5
Gwangju
Boehringer Ingelheim Investigational Site 6
Gwangju
Boehringer Ingelheim Investigational Site 7
Gwangju
Boehringer Ingelheim Investigational Site 8
Gwangju
Boehringer Ingelheim Investigational Site 9
Gwangju
Boehringer Ingelheim Investigational Site
Gyeongbuk
Boehringer Ingelheim Investigational Site 10
Gyeonggido
Boehringer Ingelheim Investigational Site 11
Gyeonggido
Boehringer Ingelheim Investigational Site 12
Gyeonggido
Boehringer Ingelheim Investigational Site 13
Gyeonggido
Boehringer Ingelheim Investigational Site 14
Gyeonggido
Boehringer Ingelheim Investigational Site 15
Gyeonggido
Boehringer Ingelheim Investigational Site 16
Gyeonggido
Boehringer Ingelheim Investigational Site 17
Gyeonggido
Boehringer Ingelheim Investigational Site 18
Gyeonggido
Boehringer Ingelheim Investigational Site 19
Gyeonggido
Boehringer Ingelheim Investigational Site 1
Gyeonggido
Boehringer Ingelheim Investigational Site 20
Gyeonggido
Boehringer Ingelheim Investigational Site 21
Gyeonggido
Boehringer Ingelheim Investigational Site 22
Gyeonggido
Boehringer Ingelheim Investigational Site 23
Gyeonggido
Boehringer Ingelheim Investigational Site 24
Gyeonggido
Boehringer Ingelheim Investigational Site 25
Gyeonggido
Boehringer Ingelheim Investigational Site 26
Gyeonggido
Boehringer Ingelheim Investigational Site 27
Gyeonggido
Boehringer Ingelheim Investigational Site 28
Gyeonggido
Boehringer Ingelheim Investigational Site 29
Gyeonggido
Boehringer Ingelheim Investigational Site 2
Gyeonggido
Boehringer Ingelheim Investigational Site 30
Gyeonggido
Boehringer Ingelheim Investigational Site 31
Gyeonggido
Boehringer Ingelheim Investigational Site 32
Gyeonggido
Boehringer Ingelheim Investigational Site 33
Gyeonggido
Boehringer Ingelheim Investigational Site 34
Gyeonggido
Boehringer Ingelheim Investigational Site 35
Gyeonggido
Boehringer Ingelheim Investigational Site 36
Gyeonggido
Boehringer Ingelheim Investigational Site 37
Gyeonggido
Boehringer Ingelheim Investigational Site 38
Gyeonggido
Boehringer Ingelheim Investigational Site 39
Gyeonggido
Boehringer Ingelheim Investigational Site 3
Gyeonggido
Boehringer Ingelheim Investigational Site 40
Gyeonggido
Boehringer Ingelheim Investigational Site 41
Gyeonggido
Boehringer Ingelheim Investigational Site 42
Gyeonggido
Boehringer Ingelheim Investigational Site 43
Gyeonggido
Boehringer Ingelheim Investigational Site 44
Gyeonggido
Boehringer Ingelheim Investigational Site 45
Gyeonggido
Boehringer Ingelheim Investigational Site 46
Gyeonggido
Boehringer Ingelheim Investigational Site 47
Gyeonggido
Boehringer Ingelheim Investigational Site 48
Gyeonggido
Boehringer Ingelheim Investigational Site 49
Gyeonggido
Boehringer Ingelheim Investigational Site 4
Gyeonggido
Boehringer Ingelheim Investigational Site 50
Gyeonggido
Boehringer Ingelheim Investigational Site 51
Gyeonggido
Boehringer Ingelheim Investigational Site 52
Gyeonggido
Boehringer Ingelheim Investigational Site 53
Gyeonggido
Boehringer Ingelheim Investigational Site 54
Gyeonggido
Boehringer Ingelheim Investigational Site 55
Gyeonggido
Boehringer Ingelheim Investigational Site 56
Gyeonggido
Boehringer Ingelheim Investigational Site 57
Gyeonggido
Boehringer Ingelheim Investigational Site 58
Gyeonggido
Boehringer Ingelheim Investigational Site 59
Gyeonggido
Boehringer Ingelheim Investigational Site 5
Gyeonggido
Boehringer Ingelheim Investigational Site 60
Gyeonggido
Boehringer Ingelheim Investigational Site 61
Gyeonggido
Boehringer Ingelheim Investigational Site 62
Gyeonggido
Boehringer Ingelheim Investigational Site 63
Gyeonggido
Boehringer Ingelheim Investigational Site 64
Gyeonggido
Boehringer Ingelheim Investigational Site 65
Gyeonggido
Boehringer Ingelheim Investigational Site 66
Gyeonggido
Boehringer Ingelheim Investigational Site 67
Gyeonggido
Boehringer Ingelheim Investigational Site 68
Gyeonggido
Boehringer Ingelheim Investigational Site 69
Gyeonggido
Boehringer Ingelheim Investigational Site 6
Gyeonggido
Boehringer Ingelheim Investigational Site 70
Gyeonggido
Boehringer Ingelheim Investigational Site 71
Gyeonggido
Boehringer Ingelheim Investigational Site 7
Gyeonggido
Boehringer Ingelheim Investigational Site 8
Gyeonggido
Boehringer Ingelheim Investigational Site 9
Gyeonggido
Boehringer Ingelheim Investigational Site
Gyeongnam
Boehringer Ingelheim Investigational Site 1
Incheon
Boehringer Ingelheim Investigational Site 2
Incheon
Boehringer Ingelheim Investigational Site 3
Incheon
Boehringer Ingelheim Investigational Site 4
Incheon
Boehringer Ingelheim Investigational Site 5
Incheon
Boehringer Ingelheim Investigational Site 6
Incheon
Boehringer Ingelheim Investigational Site 7
Incheon
Boehringer Ingelheim Investigational Site 8
Incheon
Boehringer Ingelheim Investigational Site 9
Incheon
Boehringer Ingelheim Investigational Site 1
Jeju City
Boehringer Ingelheim Investigational Site 2
Jeju City
Boehringer Ingelheim Investigational Site
Jeonbuk
Boehringer Ingelheim Investigational Site 1
Jeonnam
Boehringer Ingelheim Investigational Site 2
Jeonnam
Boehringer Ingelheim Investigational Site 3
Jeonnam
Boehringer Ingelheim Investigational Site 1
Jungnam
Boehringer Ingelheim Investigational Site 2
Jungnam
Boehringer Ingelheim Investigational Site 10
Seoul
Boehringer Ingelheim Investigational Site 11
Seoul
Boehringer Ingelheim Investigational Site 12
Seoul
Boehringer Ingelheim Investigational Site 13
Seoul
Boehringer Ingelheim Investigational Site 14
Seoul
Boehringer Ingelheim Investigational Site 15
Seoul
Boehringer Ingelheim Investigational Site 16
Seoul
Boehringer Ingelheim Investigational Site 17
Seoul
Boehringer Ingelheim Investigational Site 18
Seoul
Boehringer Ingelheim Investigational Site 19
Seoul
Boehringer Ingelheim Investigational Site 1
Seoul
Boehringer Ingelheim Investigational Site 20
Seoul
Boehringer Ingelheim Investigational Site 21
Seoul
Boehringer Ingelheim Investigational Site 22
Seoul
Boehringer Ingelheim Investigational Site 23
Seoul
Boehringer Ingelheim Investigational Site 24
Seoul
Boehringer Ingelheim Investigational Site 25
Seoul
Boehringer Ingelheim Investigational Site 26
Seoul
Boehringer Ingelheim Investigational Site 27
Seoul
Boehringer Ingelheim Investigational Site 28
Seoul
Boehringer Ingelheim Investigational Site 29
Seoul
Boehringer Ingelheim Investigational Site 2
Seoul
Boehringer Ingelheim Investigational Site 30
Seoul
Boehringer Ingelheim Investigational Site 31
Seoul
Boehringer Ingelheim Investigational Site 32
Seoul
Boehringer Ingelheim Investigational Site 33
Seoul
Boehringer Ingelheim Investigational Site 34
Seoul
Boehringer Ingelheim Investigational Site 35
Seoul
Boehringer Ingelheim Investigational Site 36
Seoul
Boehringer Ingelheim Investigational Site 37
Seoul
Boehringer Ingelheim Investigational Site 38
Seoul
Boehringer Ingelheim Investigational Site 39
Seoul
Boehringer Ingelheim Investigational Site 3
Seoul
Boehringer Ingelheim Investigational Site 40
Seoul
Boehringer Ingelheim Investigational Site 41
Seoul
Boehringer Ingelheim Investigational Site 42
Seoul
Boehringer Ingelheim Investigational Site 43
Seoul
Boehringer Ingelheim Investigational Site 44
Seoul
Boehringer Ingelheim Investigational Site 45
Seoul
Boehringer Ingelheim Investigational Site 46
Seoul
Boehringer Ingelheim Investigational Site 47
Seoul
Boehringer Ingelheim Investigational Site 48
Seoul
Boehringer Ingelheim Investigational Site 49
Seoul
Boehringer Ingelheim Investigational Site 4
Seoul
Boehringer Ingelheim Investigational Site 50
Seoul
Boehringer Ingelheim Investigational Site 51
Seoul
Boehringer Ingelheim Investigational Site 52
Seoul
About this study
Official title: PMS Study of MicardisPlus Tablet
This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:
- Unexpected adverse drug reactions (especially, serious adverse events (SAEs))
- Frequency of incidence and its change in adverse events (AEs)
- Factors on the safety profile of the study drug
- Factors on the efficacy profile of the study drug
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexpected Adverse Events
Occurrence status of unexpected adverse events
Measured: Up to 6 years
Frequency of Adverse Events
Measured: Up to 6 years
Change From Baseline in SBP (Systolic Blood Pressure) at Week 2
Effect on decrease in systolic blood pressure
Measured: Baseline and End of Study
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2
Effect on decrease in diastolic blood pressure
Measured: 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:
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)
Measured: Baseline and End of Study
Secondary outcomes (10)
Gender Factors Affecting the Safety Profile
Occurrence status of adverse events by Gender category of patients
Measured: Up to 6 years
Age Factors Affecting the Safety Profile
Occurrence status of adverse events by Age category of patients
Measured: 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
Measured: Up to 6 years
Treatment Type Factors Affecting the Safety Profile
Occurrence status of adverse events by Treatment type of patients
Measured: Up to 6 years
Medical History Factors Affecting the Safety Profile
Occurrence status of adverse events by medical history of patients
Measured: Up to 6 years
Concomitant Disease Factors Affecting the Safety Profile
Occurrence status of adverse events by Concomitant disease of patients
Measured: Up to 6 years
Medical History Factors Affecting the Efficacy Profile
Efficacy rate by medical characteristic of patients
Measured: Baseline and End of Study
Previous Medication Factors Affecting the Efficacy Profile
Efficacy rate by medical characteristic of patients
Measured: 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)
Measured: 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
Measured: Baseline and End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startSep 2003
- Primary completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 6,901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659607
- Sponsor's protocol ID
- 502.475
- Status last verified
- May 2014
- First submitted
- 10 Apr 2008
- Last updated
- 6 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMS Study of MicardisPlus Tablet
- ClinicalTrials.gov ID
- NCT00659607
- Acronym / sponsor ID
- 502.475
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,901 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Jul 2008 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 22 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:
- Unexpected adverse drug reactions (especially, serious adverse events (SAEs))
- Frequency of incidence and its change in adverse events (AEs)
- Factors on the safety profile of the study drug
- Factors on the efficacy profile of the study drug
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitals and clinics in Korea
Key inclusion criteria (1 listed)
- patients diagnosed with essential hypertension
Key exclusion criteria (1 listed)
- patients who took Micardis Plus before participating in this PMS study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Unexpected Adverse Events
Time frame: Up to 6 years
Occurrence status of unexpected adverse events
Frequency of Adverse Events
Time frame: Up to 6 years
Change From Baseline in SBP (Systolic Blood Pressure) at Week 2
Time frame: Baseline and End of Study
Effect on decrease in systolic blood pressure
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2
Time frame: Baseline and End of Study
Effect on decrease in diastolic blood pressure
Effective Rate
Time frame: 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)
10 secondary outcomes
Gender Factors Affecting the Safety Profile
Time frame: Up to 6 years
Age Factors Affecting the Safety Profile
Time frame: Up to 6 years
Proportion of Geriatric Population Factor Affecting the Safety Profile
Time frame: Up to 6 years
Treatment Type Factors Affecting the Safety Profile
Time frame: Up to 6 years
Medical History Factors Affecting the Safety Profile
Time frame: Up to 6 years
Concomitant Disease Factors Affecting the Safety Profile
Time frame: Up to 6 years
Medical History Factors Affecting the Efficacy Profile
Time frame: Baseline and End of Study
Previous Medication Factors Affecting the Efficacy Profile
Time frame: Baseline and End of Study
Baseline Severity of Hypertension Factors Affecting the Efficacy Profile
Time frame: Baseline and End of Study
Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile
Time frame: Baseline and End of Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
326 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Boehringer Ingelheim at 326 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 326 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexpected Adverse Events (time frame: Up to 6 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.