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

NCT ID: NCT02206659

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31

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

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telmisartan

2-week placebo run-in period followed by 6 weeks of treatment with telmisartan

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Telmisartan

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

502.367

Identifier Type: -

Identifier Source: org_study_id