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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: Telmisartan

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Primary Completion (Actual): February 1, 2001

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Estimate): August 1, 2014
• Last Update Submitted That Met QC Criteria: July 31, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan
• Other Study ID Numbers: 502.367