Trial Outcomes & Findings for Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension (NCT NCT00659607)
NCT ID: NCT00659607
Last Updated: 2014-06-06
Results Overview
Occurrence status of unexpected adverse events
COMPLETED
6901 participants
Up to 6 years
2014-06-06
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 milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
3932
|
|
Overall Study
COMPLETED
|
3616
|
|
Overall Study
NOT COMPLETED
|
316
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
No blood pressure recorded
|
147
|
|
Overall Study
Unknown measuring date of blood pressure
|
85
|
|
Overall Study
'Unable to evaluate' for the final asses
|
67
|
|
Overall Study
No recorded efficacy data
|
15
|
|
Overall Study
Inconsistent BP measuring date
|
2
|
Baseline Characteristics
Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension
Baseline characteristics by cohort
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3917 Participants
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.
|
|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 12 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2057 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1860 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 6 yearsPopulation: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
Occurrence status of unexpected adverse events
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3932 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Unexpected Adverse Events
|
0.58 Percentage of patients
|
PRIMARY outcome
Timeframe: Up to 6 yearsPopulation: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3932 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Frequency of Adverse Events
|
1.04 Percentage of patients
|
PRIMARY outcome
Timeframe: Baseline and End of StudyPopulation: Out of 6,901 patients, 3,616 patients for the efficacy assessment
Effect on decrease in systolic blood pressure
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3614 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Change From Baseline in SBP (Systolic Blood Pressure) at Week 2
|
-29 mmHg
Standard Deviation 16
|
PRIMARY outcome
Timeframe: Baseline and End of StudyPopulation: Out of 6,901 patients, 3,616 patients for the efficacy assessment
Effect on decrease in diastolic blood pressure
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3614 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2
|
-15 mmHg
Standard Deviation 11
|
PRIMARY outcome
Timeframe: Baseline and End of StudyPopulation: Out of 6,901 patients, 3,616 patients for the efficacy assessment
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)
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3616 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Effective Rate
|
99 Percentage of patients
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Gender not recorded for 15 patients
Occurrence status of adverse events by Gender category of patients
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3917 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Gender Factors Affecting the Safety Profile
Male
|
1.24 Percentage of patients
Interval 0.79 to 1.85
|
|
Gender Factors Affecting the Safety Profile
Female
|
0.88 Percentage of patients
Interval 0.52 to 1.38
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients
Occurrence status of adverse events by Age category of patients
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3917 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Age Factors Affecting the Safety Profile
20 ≤ age < 30
|
0 Percentage of patients
Percentage of Patients with this category is 0
|
|
Age Factors Affecting the Safety Profile
30 ≤ age < 40
|
1.32 Percentage of patients
Interval 0.16 to 4.7
|
|
Age Factors Affecting the Safety Profile
40 ≤ age < 50
|
1.20 Percentage of patients
Interval 0.52 to 2.34
|
|
Age Factors Affecting the Safety Profile
50 ≤ age < 60
|
1.13 Percentage of patients
Interval 0.58 to 1.96
|
|
Age Factors Affecting the Safety Profile
60 ≤ age < 70
|
0.88 Percentage of patients
Interval 0.42 to 1.62
|
|
Age Factors Affecting the Safety Profile
≥ 70
|
1.04 Percentage of patients
Interval 0.48 to 1.96
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients
Occurrence status of adverse events by Proportion of geriatric population of patients
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3917 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Proportion of Geriatric Population Factor Affecting the Safety Profile
< 65
|
1.03 Percentage of patients
Interval 0.68 to 1.51
|
|
Proportion of Geriatric Population Factor Affecting the Safety Profile
>= 65
|
1.07 Percentage of patients
Interval 0.6 to 1.76
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Treatment type not recorded for 294 patients
Occurrence status of adverse events by Treatment type of patients
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3638 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Treatment Type Factors Affecting the Safety Profile
In-patient
|
0 Percentage of patients
Percentage of Patients with this category is 0
|
|
Treatment Type Factors Affecting the Safety Profile
Out-patient
|
1.10 Percentage of patients
Interval 0.78 to 1.51
|
|
Treatment Type Factors Affecting the Safety Profile
In-patient and outpatient alternatively
|
1.40 Percentage of patients
Interval 0.17 to 4.96
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
Occurrence status of adverse events by medical history of patients
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3932 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Medical History Factors Affecting the Safety Profile
With Medical history
|
1.97 Percentage of patients
Interval 1.24 to 2.96
|
|
Medical History Factors Affecting the Safety Profile
Without Medical history
|
0.68 Percentage of patients
Interval 0.41 to 1.05
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
Occurrence status of adverse events by Concomitant disease of patients
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3932 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Concomitant Disease Factors Affecting the Safety Profile
With Concomitant disease
|
2.30 Percentage of patients
Interval 1.49 to 3.38
|
|
Concomitant Disease Factors Affecting the Safety Profile
Without Concomitant disease
|
0.56 Percentage of patients
Interval 0.32 to 0.91
|
SECONDARY outcome
Timeframe: Baseline and End of StudyPopulation: Out of 6,901 patients, 3,616 patients for the efficacy assessment
Efficacy rate by medical characteristic of patients
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3616 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Medical History Factors Affecting the Efficacy Profile
With Medical history
|
98.1 Percentage of patients
|
|
Medical History Factors Affecting the Efficacy Profile
Without Medical history
|
99.2 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and End of StudyPopulation: Out of 6,901 patients, 3,616 patients for the efficacy assessment
Efficacy rate by medical characteristic of patients
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3616 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Previous Medication Factors Affecting the Efficacy Profile
With Previous medication
|
98.3 Percentage of patients
|
|
Previous Medication Factors Affecting the Efficacy Profile
Without Previous medication
|
99.6 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and End of StudyPopulation: Out of 6,901 patients, 3,616 patients for the efficacy assessment
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)
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3616 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Baseline Severity of Hypertension Factors Affecting the Efficacy Profile
Stage 1
|
98.3 Percentage of patients
|
|
Baseline Severity of Hypertension Factors Affecting the Efficacy Profile
Stage 2
|
99.2 Percentage of patients
|
|
Baseline Severity of Hypertension Factors Affecting the Efficacy Profile
Stage 3
|
98.3 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and End of StudyPopulation: Out of 6,901 patients, 3,616 patients for the efficacy assessment and Daily dose not recorded for 26 patients
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
Outcome measures
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3590 Participants
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
|
|---|---|
|
Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile
40/12.5mg
|
98.8 Percentage of patients
|
|
Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile
40/12.5mg < daily dose < 80/12.5mg
|
95.8 Percentage of patients
|
|
Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile
80/12.5mg
|
99.4 Percentage of patients
|
Adverse Events
Hypertensive Patients With Micardis Plus for the First Time
Serious adverse events
| Measure |
Hypertensive Patients With Micardis Plus for the First Time
n=3932 participants at risk
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.
|
|---|---|
|
Vascular disorders
Stroke
|
0.03%
1/3932 • Over a period of 6 years
The number of patients for safety assessment is 3932.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER