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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Telmisartan

Criteria

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