Hypertension
Conditions
Brief summary
Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.
Interventions
DRUGTelmisartan
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic)
Exclusion criteria
\- corresponding to the contraindications listed in the summary of product characteristics of the drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of changes in heart rate | Baseline, up to 8 weeks after start of treatment |
| Assessment for patients with changes in laboratory values | Baseline, up to 8 weeks after start of treatment |
| Number of patients with adverse events | Up to 8 weeks after start of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in mean systolic and diastolic blood pressure values | Baseline, up to 8 weeks after start of treatment | Measured by means of ambulatory blood pressure monitoring (ABPM) over 24 hours |
| Evaluation of treatment compliance as percentage of tablets planned | Up to 8 weeks after start of treatment | (number of tablets taken / total number of days) x 100 |
Outcome results
None listed