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OpenTrials
Completed

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

Completed

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Key information

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

Telmisartan

Drug

Placebo

Drug

Primary outcomes

  1. 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

  2. Median of T/P ratio for DBP and SBP

    Time frame: 42 days after start of treatment

Secondary outcomes

  1. Change in mean 24-hr DBP and SBP

    Time frame: Day -13, 42 days after start of treatment

  2. Change in daytime mean for SBP and DBP

    Time frame: Day -13, 42 days after start of treatment

  3. Change in nighttime mean for SBP and DBP

    Time frame: Day -13, 42 days after start of treatment

  4. 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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