Hypertension
Conditions
Brief summary
To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure monitoring in Chinese patients with mild to moderate essential hypertension
Interventions
DRUGTelmisartan
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chinese male or female aged 18 to 75 years * Mild to moderate hypertension defined as a morning DBP \_95 and \<110 mm Hg at visit1 and visit 2. Mean sitting systolic pressure (SBP) must be \<180 mm Hg * Ability to provide written informed consent
Exclusion criteria
* Women who are pregnant or breast-feeding, or of childbearing potential without an effective method of birth control (effective birth control methods are: uterine device, surgical sterilisation, progestogens alone) * Known or suspected secondary hypertension * Known history of any chronic hepatic disease * Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant * New York Heart Association (NYHA) functional class congestive heart failure (CHF) III-IV * Unstable angina pectoris * Myocardial infarction or percutaneous transluminal coronary angiography (PTCA) or cardiac surgery within the preceding three months * Clinical relevant cardiac arrhythmias as determined by the clinical investigator * Hypertrophic obstructive cardiomyopathy or clinically significant valvular disease * Evidence of retinal hemorrhages/exudates * Clinical significant hyperkalemia as defined by serum potassium level \>6.0 milliequivalents (mEq)/L * Insulin-dependent diabetes mellitus * Non-insulin-dependent diabetes mellitus with poor glucose control as defined by persistent fasting blood sugar \>200 mg/dl, peripheral neuropathy or autonomic neuropathy * Known drug or alcohol dependency * Administration of any diuretic, ACE inhibitor or angiotensin II receptor antagonist within two weeks before run-in period * Administration of medication known to affect blood pressure during trial period * Patients receiving any investigational therapy within one month of signing the informed consent form * Known hypersensitivity to any component of the formulation * Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of trial medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP) | 42 days after start of treatment |
| Median of T/P ratio for DBP and SBP | 42 days after start of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean 24-hr DBP and SBP | Day -13, 42 days after start of treatment |
| Change in daytime mean for SBP and DBP | Day -13, 42 days after start of treatment |
| Change in nighttime mean for SBP and DBP | Day -13, 42 days after start of treatment |
| Change in mean of DBP and SBP for last 6-hr dosing interval | Day -13, 42 days after start of treatment |
Outcome results
None listed