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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
489
telmisartan 80 mg once daily
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
Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg
Time frame: Up to one year
Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy
Time frame: Up to one year
Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy
Time frame: Up to one year
Mean sitting diastolic blood pressure during each visit
Time frame: At months 3, 6, 9, 12
Mean sitting systolic blood pressure during each visit
Time frame: At months 3, 6, 9, 12
Number of patient with adverse events
Time frame: Up to one year
Changes from baseline in heart rate
Time frame: Baseline and at months 3, 6, 9, 12
Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram)
Time frame: Baseline and 12 months
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline and 12 months
Number of patients with abnormal findings in physical examination
Time frame: Baseline and at 12 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.