Hypertension
Conditions
Brief summary
To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2 consecutive visits), who were 18 years old and older, regardless of sex
Exclusion criteria
* Suspected or known diagnosis of arterial hypertension with a secondary cause * Women who were not using an effective method of contraception, or who were pregnant, or breast-feeding * Systolic blood pressure \> 200 mm Hg or diastolic blood pressure \> 115 mm Hg * Laboratory test values two fold above the upper normal limit * Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II blocker (AIIAR) * New York Heart Association class III or IV heart failure * History of stroke in the 6 months prior to entry into the study * Uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels \> 140 mg/dL on 3 consecutive assessments * Patients who were included in another investigational drug study in the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) | Baseline, up to 12 weeks after start of treatment | Blood pressure values were obtained 24 hours after the last dose (through values) at the office |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of treatment response for SBP/DBP (in %) | Baseline, up to 12 weeks after start of treatment | Response categories: * SBP \< 140 mm Hg or * DBP \< 90 mm Hg or * BP reduction ≥ 10 mm Hg |
| Changes from baseline in blood pressure values | Baseline, up to 12 weeks after start of treatment | Analysis performed for the ambulatory blood pressure monitoring (ABPM) - subgroup |
| Number of patients with adverse events | Up to 16 weeks | — |
| Number of patients with clinically significant changes in laboratory values | Up to 16 weeks | — |
| Number of patients with clinically significant changes in ECG | Up to 16 weeks | — |
Outcome results
None listed