Effects of Telmisartan by Ambulatory Blood Pressure Monitoring (ABPM) in Chinese Patients With Mild to Moderate Essential Hypertension

Study Overview
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Brief Summary
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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

Official Title
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An Open-label Evaluation of Trough and Peak Effects of 40 mg Telmisartan Tablet by Ambulatory Blood Pressure Monitoring in Chinese Patients With Mild to Moderate Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan<br>2-week placebo run-in period followed by 6 weeks of treatment with telmisartan | Drug: Telmisartan<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |