An observational study in Hypertension, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2014-03-28.
Sponsored by Boehringer Ingelheim · Observational
Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 670 is above the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →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.
hypertensive patients
Exclusion criteria:
None (according to investigator)
Drug: Micardis
Efficacy (Change of Systolic Blood Pressure)
Change from baseline in 24h systolic blood pressure (BP) at week 8
Time frame: baseline to 8 weeks
Efficacy (Change of Diastolic Blood Pressure)
Change from baseline in 24h diastolic blood pressure (BP) at week 8
Time frame: baseline to 8 weeks
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
| Milestone | Telmisartan, Hydrochlorothiazide |
|---|---|
| Started | 701 |
| Completed | 539 |
| Not completed | 162 |
| Withdrew: Lost to follow-up (non-ae) | 162 |
Change from baseline in 24h systolic blood pressure (BP) at week 8
| mm Hg | Telmisartan, Hydrochlorothiazide |
|---|---|
| Efficacy (Change of Systolic Blood Pressure) | 8.6 ± 17.8 |
Change from baseline in 24h diastolic blood pressure (BP) at week 8
| mm Hg | Telmisartan, Hydrochlorothiazide |
|---|---|
| Efficacy (Change of Diastolic Blood Pressure) | 4.7 ± 12.7 |
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
| units on a scale | Telmisartan, Hydrochlorothiazide |
|---|---|
| Overall Tolerability Scale | 9.2 ± 1.5 |
Collected over 56 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telmisartan, Hydrochlorothiazide | — | 0/701 (0%) | 0/701 (0%) |
| Age, Continuous(Year) | Telmisartan, Hydrochlorothiazide |
|---|---|
| Mean | 60.5 ± 12.8 |
| Gender(participants) | Telmisartan, Hydrochlorothiazide |
|---|---|
| Female | 324 |
| Male | 357 |
| Baseline Diastolic Blood Pressure (DBP) values (ABPM)(mm Hg) | Telmisartan, Hydrochlorothiazide |
|---|---|
| Mean | 82 ± 9.6 |
| Baseline Systolic Blood Pressure (SBP) values (ABPM)(mm Hg) | Telmisartan, Hydrochlorothiazide |
|---|---|
| Mean | 136 ± 13.2 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim