Clinical trial NCT02206659: Effects of Telmisartan by Ambulatory Blood Pressure Monitoring (ABPM) in Chinese Patients With Mild to Moderate Essential Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)
timeFrame: 42 days after start of treatment
measure: Median of T/P ratio for DBP and SBP
timeFrame: 42 days after start of treatment
Secondary outcomes:
measure: Change in mean 24-hr DBP and SBP
timeFrame: Day -13, 42 days after start of treatment
measure: Change in daytime mean for SBP and DBP
timeFrame: Day -13, 42 days after start of treatment
measure: Change in nighttime mean for SBP and DBP
timeFrame: Day -13, 42 days after start of treatment
measure: Change in mean of DBP and SBP for last 6-hr dosing interval
timeFrame: Day -13, 42 days after start of treatment
Other outcomes:
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