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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan; Drug: Placebo

• Registration Number: NCT02206659
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2001-02
• Status Verified: 2014-07
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-07-31
• Last Update Submitted: 2014-07-31
• Study First Posted: 2014-08-01
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telmisartan	Placebo	2-week placebo run-in period followed by 6 weeks of treatment with telmisartan
Telmisartan	Telmisartan	2-week placebo run-in period followed by 6 weeks of treatment with telmisartan

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in mean 24-hr DBP and SBP	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 daytime 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