Hypertension
Conditions
Brief summary
Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients
Interventions
DRUGMicardis
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who have recently been diagnosed with hypertension 2. Patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion.
Exclusion criteria
None (according to investigator)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (Change of Systolic Blood Pressure) | baseline to 8 weeks | Change from baseline in 24h systolic blood pressure (BP) at week 8 |
| Efficacy (Change of Diastolic Blood Pressure) | baseline to 8 weeks | Change from baseline in 24h diastolic blood pressure (BP) at week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Tolerability Scale | 8 weeks | Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan, Hydrochlorothiazide | 701 |
| Total | 701 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | lost to follow-up (non-AE) | 162 |
Baseline characteristics
| Characteristic | Telmisartan, Hydrochlorothiazide |
|---|---|
| Age, Continuous | 60.5 Year STANDARD_DEVIATION 12.8 |
| Baseline Diastolic Blood Pressure (DBP) values (ABPM) | 82 mm Hg STANDARD_DEVIATION 9.6 |
| Baseline Systolic Blood Pressure (SBP) values (ABPM) | 136 mm Hg STANDARD_DEVIATION 13.2 |
| Gender Female | 324 participants |
| Gender Male | 357 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 701 |
| serious Total, serious adverse events | 0 / 701 |
Outcome results
Primary
Efficacy (Change of Diastolic Blood Pressure)
Change from baseline in 24h diastolic blood pressure (BP) at week 8
Time frame: baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan, Hydrochlorothiazide | Efficacy (Change of Diastolic Blood Pressure) | 4.7 mm Hg | Standard Deviation 12.7 |
Primary
Efficacy (Change of Systolic Blood Pressure)
Change from baseline in 24h systolic blood pressure (BP) at week 8
Time frame: baseline to 8 weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan, Hydrochlorothiazide | Efficacy (Change of Systolic Blood Pressure) | 8.6 mm Hg | Standard Deviation 17.8 |
Secondary
Overall Tolerability Scale
Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan, Hydrochlorothiazide | Overall Tolerability Scale | 9.2 units on a scale | Standard Deviation 1.5 |