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CompletedNCT00659607Updated Jun 6, 2014Results posted

Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

An observational study in Hypertension, sponsored by Boehringer Ingelheim. Completed at 326 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-06.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
6,901
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 6,901 is above the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Hospitals and clinics in Korea

Inclusion criteria

patients diagnosed with essential hypertension

Exclusion criteria

Exclusion Criteria:

patients who took Micardis Plus before participating in this PMS study

05

Study design

Time perspective
Prospective
Enrollment
6,901 participants (actual)
06

What researchers measure

Primary outcomes

  1. Unexpected Adverse Events

    Occurrence status of unexpected adverse events

    Time frame: Up to 6 years

  2. Frequency of Adverse Events

    Time frame: Up to 6 years

  3. Change From Baseline in SBP (Systolic Blood Pressure) at Week 2

    Effect on decrease in systolic blood pressure

    Time frame: Baseline and End of Study

  4. Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2

    Effect on decrease in diastolic blood pressure

    Time frame: Baseline and End of Study

  5. 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)

    Time frame: Baseline and End of Study

Secondary outcomes

  1. Gender Factors Affecting the Safety Profile

    Occurrence status of adverse events by Gender category of patients

    Time frame: Up to 6 years

  2. Age Factors Affecting the Safety Profile

    Occurrence status of adverse events by Age category of patients

    Time frame: Up to 6 years

  3. Proportion of Geriatric Population Factor Affecting the Safety Profile

    Occurrence status of adverse events by Proportion of geriatric population of patients

    Time frame: Up to 6 years

  4. Treatment Type Factors Affecting the Safety Profile

    Occurrence status of adverse events by Treatment type of patients

    Time frame: Up to 6 years

  5. Medical History Factors Affecting the Safety Profile

    Occurrence status of adverse events by medical history of patients

    Time frame: Up to 6 years

  6. Concomitant Disease Factors Affecting the Safety Profile

    Occurrence status of adverse events by Concomitant disease of patients

    Time frame: Up to 6 years

  7. Medical History Factors Affecting the Efficacy Profile

    Efficacy rate by medical characteristic of patients

    Time frame: Baseline and End of Study

  8. Previous Medication Factors Affecting the Efficacy Profile

    Efficacy rate by medical characteristic of patients

    Time frame: Baseline and End of Study

  9. 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)

    Time frame: Baseline and End of Study

  10. 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

    Time frame: Baseline and End of Study

07

Results

Posted Oct 22, 2009

Participant flow

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.

Participant flow — Overall Study
MilestoneHypertensive Patients With Micardis Plus for the First Time
Started3932
Completed3616
Not completed316
Withdrew: No blood pressure recorded147
Withdrew: Unknown measuring date of blood pressure85
Withdrew: 'unable to evaluate' for the final asses67
Withdrew: No recorded efficacy data15
Withdrew: Inconsistent bp measuring date2

Outcome measures

PrimaryUnexpected Adverse Events

Occurrence status of unexpected adverse events

Time frame:
Up to 6 years
Reported as:
Number · Percentage of patients
Unexpected Adverse Events
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
Unexpected Adverse Events0.58
PrimaryFrequency of Adverse Events
Time frame:
Up to 6 years
Reported as:
Number · Percentage of patients
Frequency of Adverse Events
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
Frequency of Adverse Events1.04
PrimaryChange From Baseline in SBP (Systolic Blood Pressure) at Week 2

Effect on decrease in systolic blood pressure

Time frame:
Baseline and End of Study
Reported as:
Mean · mmHg
Change From Baseline in SBP (Systolic Blood Pressure) at Week 2
mmHgHypertensive Patients With Micardis Plus for the First Time
Change From Baseline in SBP (Systolic Blood Pressure) at Week 2-29 ± 16
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · t-test for paired observations · p = <0.0001
SecondaryGender Factors Affecting the Safety Profile

Occurrence status of adverse events by Gender category of patients

Time frame:
Up to 6 years
Reported as:
Number · Percentage of patients
Gender Factors Affecting the Safety Profile
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
Male1.24 (0.79 to 1.85)
Female0.88 (0.52 to 1.38)
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · Chi-squared · p = 0.2669
SecondaryAge Factors Affecting the Safety Profile

Occurrence status of adverse events by Age category of patients

Time frame:
Up to 6 years
Reported as:
Number · Percentage of patients
Age Factors Affecting the Safety Profile
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
20 ≤ age < 300 (NA to NA)
30 ≤ age < 401.32 (0.16 to 4.70)
40 ≤ age < 501.20 (0.52 to 2.34)
50 ≤ age < 601.13 (0.58 to 1.96)
60 ≤ age < 700.88 (0.42 to 1.62)
≥ 701.04 (0.48 to 1.96)
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · Chi-squared · p = 0.9674
SecondaryProportion of Geriatric Population Factor Affecting the Safety Profile

Occurrence status of adverse events by Proportion of geriatric population of patients

Time frame:
Up to 6 years
Reported as:
Number · Percentage of patients
Proportion of Geriatric Population Factor Affecting the Safety Profile
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
< 651.03 (0.68 to 1.51)
>= 651.07 (0.60 to 1.76)
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · Chi-squared · p = 0.9207
SecondaryTreatment Type Factors Affecting the Safety Profile

Occurrence status of adverse events by Treatment type of patients

Time frame:
Up to 6 years
Reported as:
Number · Percentage of patients
Treatment Type Factors Affecting the Safety Profile
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
In-patient0 (NA to NA)
Out-patient1.10 (0.78 to 1.51)
In-patient and outpatient alternatively1.40 (0.17 to 4.96)
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · Fisher Exact · p = 0.8249
PrimaryChange From Baseline in DBP (Diastolic Blood Pressure) at Week 2

Effect on decrease in diastolic blood pressure

Time frame:
Baseline and End of Study
Reported as:
Mean · mmHg
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2
mmHgHypertensive Patients With Micardis Plus for the First Time
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2-15 ± 11
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · t-test for paired observations · p = <0.0001
PrimaryEffective 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)

Time frame:
Baseline and End of Study
Reported as:
Number · Percentage of patients
Effective Rate
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
Effective Rate99
SecondaryMedical History Factors Affecting the Safety Profile

Occurrence status of adverse events by medical history of patients

Time frame:
Up to 6 years
Reported as:
Number · Percentage of patients
Medical History Factors Affecting the Safety Profile
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
With Medical history1.97 (1.24 to 2.96)
Without Medical history0.68 (0.41 to 1.05)
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · Chi-squared · p = 0.0003 · Odds ratio (or): 2.2 · 95% CI 1.121 to 4.151The estimation of Odds Ratio and 95% Confidence Interval based on the logistic regression analysis
SecondaryConcomitant Disease Factors Affecting the Safety Profile

Occurrence status of adverse events by Concomitant disease of patients

Time frame:
Up to 6 years
Reported as:
Number · Percentage of patients
Concomitant Disease Factors Affecting the Safety Profile
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
With Concomitant disease2.30 (1.49 to 3.38)
Without Concomitant disease0.56 (0.32 to 0.91)
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · Chi-squared · p = <0.0001 · Odds ratio (or): 3.3 · 95% CI 1.642 to 6.776The Estimation of Odds Ratio and 95% Confidence Interval based the logistic regression analysis
SecondaryMedical History Factors Affecting the Efficacy Profile

Efficacy rate by medical characteristic of patients

Time frame:
Baseline and End of Study
Reported as:
Number · Percentage of patients
Medical History Factors Affecting the Efficacy Profile
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
With Medical history98.1
Without Medical history99.2
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · Chi-squared · p = 0.0075
SecondaryPrevious Medication Factors Affecting the Efficacy Profile

Efficacy rate by medical characteristic of patients

Time frame:
Baseline and End of Study
Reported as:
Number · Percentage of patients
Previous Medication Factors Affecting the Efficacy Profile
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
With Previous medication98.3
Without Previous medication99.6
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · Chi-squared · p = 0.0007
SecondaryBaseline 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)

Time frame:
Baseline and End of Study
Reported as:
Number · Percentage of patients
Baseline Severity of Hypertension Factors Affecting the Efficacy Profile
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
Stage 198.3
Stage 299.2
Stage 398.3
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · Chi-squared · p = 0.0393
SecondaryDaily 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

Time frame:
Baseline and End of Study
Reported as:
Number · Percentage of patients
Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile
Percentage of patientsHypertensive Patients With Micardis Plus for the First Time
40/12.5mg98.8
40/12.5mg < daily dose < 80/12.5mg95.8
80/12.5mg99.4
Statistical analysis
  • Hypertensive Patients With Micardis Plus for the First Time · Chi-squared · p = 0.0245

Adverse events

Collected over Over a period of 6 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Hypertensive Patients With Micardis Plus for the First Time—1/3,932 (0%)0/3,932 (0%)
Most frequent serious events
Most frequent serious events
EventHypertensive Patients With Micardis Plus for the First Time
StrokeVascular disorders1/3932

Baseline characteristics

Age, Continuous
Age, Continuous(years)Hypertensive Patients With Micardis Plus for the First Time
Mean60 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)Hypertensive Patients With Micardis Plus for the First Time
Female2057
Male1860
08

Study locations

326 sites
  • Boehringer Ingelheim Investigational Site 10
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 11
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 12
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 13
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 14
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 15
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 16
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 17
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 18
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 19
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 1
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 20
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 21
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 22
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 23
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 24
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 25
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 26
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 27
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 28
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 29
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 2
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 30
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 31
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 32
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 33
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 34
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 35
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 36
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 37
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 38
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 39
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 3
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 40
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 41
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 42
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 43
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 44
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 45
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 46
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 47
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 48
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 49
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 4
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 5
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 6
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 7
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 8
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 9
    Busan, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 1
    Chungnam, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 2
    Chungnam, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 10
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 11
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 12
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 13
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 14
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 15
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 16
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 17
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 18
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 19
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 1
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 20
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 21
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 22
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 23
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 24
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 25
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 26
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 27
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 2
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 3
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 4
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 5
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 6
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 7
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 8
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 9
    Daegu, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 10
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 11
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 12
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 13
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 14
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 15
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 16
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 17
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 18
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 19
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 1
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 20
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 21
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 22
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 23
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 24
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 25
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 26
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 27
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 28
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 29
    Daejeon, Korea, Republic of
  • Boehringer Ingelheim Investigational Site 2
    Daejeon, Korea, Republic of

Showing the first 100 of 326 sites.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00659607
Lead sponsor
Boehringer Ingelheim
First posted
Apr 16, 2008
Start date
Sep 2003
Primary completion
Jul 2008
Results posted
Oct 22, 2009
Last update
Jun 6, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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