NCT Number: NCT02206659
Effects of Telmisartan by Ambulatory Blood Pressure Monitoring (ABPM) 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
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
DrugPrimary outcomes
-
Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)
Time frame: 42 days after start of treatment
-
Median of T/P ratio for DBP and SBP
Time frame: 42 days after start of treatment
Secondary outcomes
-
Change in mean 24-hr DBP and SBP
Time frame: Day -13, 42 days after start of treatment
-
Change in daytime mean for SBP and DBP
Time frame: Day -13, 42 days after start of treatment
-
Change in nighttime mean for SBP and DBP
Time frame: Day -13, 42 days after start of treatment
-
Change in mean of DBP and SBP for last 6-hr dosing interval
Time frame: Day -13, 42 days after start of treatment
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study 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
Important dates
- Study start
- 2000
- Primary completion
- 2001
- First posted
- Aug 1, 2014
- Registry last updated
- Aug 1, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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