Hypertension
Conditions
Brief summary
The primary objective of this trial was to assess the efficacy and safety of telmisartan 80 mg during open-label, long-term treatment. An additional objective was to assess the efficacy and safety of concomitant administration of telmisartan 80 mg and HCTZ (Hydrochlorothiazide) and/or any other therapies commonly used in the treatment of hypertension.
Interventions
DRUGTelmisartan
telmisartan 80 mg once daily
DRUGHydrochlorothiazide
12.5 mg or 25 mg Hydrochlorothiazide in addition to telmisartan in case that the goal response (mean sitting diastolic blood pressure \< 90 mmHg) is not met after at least 4 weeks of treatment with telmisartan
Sponsors
Boehringer Ingelheim
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have met the inclusion criteria for the preceding clinical trial of telmisartan. All patients must give a separate written informed consent for participation in the open-label follow-up. * Mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer * Mean seated systolic blood pressure ≥ 140 mmHg, measured my manual cuff * A 24-hour mean diastolic blood pressure, measured by ABPM (ambulatory blood pressure measurement), of ≥ 85 mmHg * Age 18 or older * Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
Exclusion criteria
* Patients with a clinically significant change in ECG from baseline that was reported as an adverse event during the preceding clinical trial * Patients who have developed a medical condition during the preceding clinical trial that, in the investigator's opinion, may be worsened by treatment or may compromise the safety evaluation of telmisartan * Patients who discontinued the preceding telmisartan clinical trial due to an adverse event * Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg | Up to one year |
| Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy | Up to one year |
| Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy | Up to one year |
| Mean sitting diastolic blood pressure during each visit | At months 3, 6, 9, 12 |
| Mean sitting systolic blood pressure during each visit | At months 3, 6, 9, 12 |
| Number of patient with adverse events | Up to one year |
| Changes from baseline in heart rate | Baseline and at months 3, 6, 9, 12 |
| Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram) | Baseline and 12 months |
| Number of patients with abnormal changes in laboratory parameters | Baseline and 12 months |
| Number of patients with abnormal findings in physical examination | Baseline and at 12 month |
Outcome results
None listed