The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and telmisartan 40 mg plus HCTZ 12.5 mg in patients with essential hypertension.
This is a multi-centre study with three centres participating with a target of 30 to 90 patients entering the maintenance period and 20-60 patients completing long-term treatment per centre. The recruitment period will be about three months from the start of the study. Study Hypothesis: The primary objective of this study is to demonstrate the long-term safety of a fixed dose combination of telmisartan/HCTZ fixed-dose combination treatment. This study has no control group; therefore, no hypothesis testing will be performed. Comparison(s): This study has no control group.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Boehringer Ingelheim Investigational Site
Hiroshima-shi, Hiroshima, Japan
Boehringer Ingelheim Investigational Site
Sapporo-shi, Hokkaido, Japan
Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
Incidence of adverse events
Time frame: 52 weeks
Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)
Time frame: 52 weeks
Changes in electrocardiogram (ECG)
Time frame: 52 weeks
Changes in blood pressure and pulse rate
Time frame: 52 weeks
Seated Diastolic Blood Pressure (DBP) control rate
Time frame: after 12 and 52 weeks
Seated Systolic Blood Pressure (SBP) control rate
Time frame: after 12 and 52 weeks
Seated DBP response rate
Time frame: after 12 and 52 weeks
Seated SBP response rate
Time frame: after 12 and 52 weeks
Seated blood pressure (BP) normality criteria
Time frame: after 12 and 52 weeks
Changes in seated DBP
Time frame: after 12 and 52 weeks
Changes in seated SBP
Time frame: after 12 and 52 weeks
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