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

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Telmisartan

Placebo

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telmisartan

Arm Description

2-week placebo run-in period followed by 6 weeks of treatment with telmisartan

Outcomes

Primary Outcome Measures

Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)

Median of T/P ratio for DBP and SBP

Secondary Outcome Measures

Change in mean 24-hr DBP and SBP

Change in daytime mean for SBP and DBP

Change in nighttime mean for SBP and DBP

Change in mean of DBP and SBP for last 6-hr dosing interval

Full Information

NCT ID

NCT02206659

First Posted

July 31, 2014

Last Updated

July 31, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02206659

Brief Title

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

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

August 2000 (undefined)

Primary Completion Date

February 2001 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telmisartan

Arm Type

Experimental

Arm Description

2-week placebo run-in period followed by 6 weeks of treatment with telmisartan

Intervention Type

Drug

Intervention Name(s)

Telmisartan

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Title

Median of T/P ratio for DBP and SBP

Time Frame

42 days after start of treatment

Secondary Outcome Measure Information:

Title

Change in mean 24-hr DBP and SBP

Time Frame

Day -13, 42 days after start of treatment

Title

Change in daytime mean for SBP and DBP

Time Frame

Day -13, 42 days after start of treatment

Title

Change in nighttime mean for SBP and DBP

Time Frame

Day -13, 42 days after start of treatment

Title

Change in mean of DBP and SBP for last 6-hr dosing interval

Time Frame

Day -13, 42 days after start of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com

Description

Related Info

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

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