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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Placebo

Drug: Telmisartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02206659

502.367

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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