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Study to Evaluate the Trough and Peak Effect of Once Daily Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg (Micardis Plus) by Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Essential Hypertension

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Telmisartan
Telmisartan/HCTZ
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: History of mild-to-moderate essential hypertension defined by a mean seated DBP >= 95 and <= 109 mmHg, and SBP < 180mmHg measured by manual cuff sphygmomanometer at visit 2. Note: The manual cuff value is calculated as the mean of three seated measurements collected 2 minutes apart, after the patient has been seated quietly for 5 minutes. For calculation of mean values by the investigator, decimal places should be rounded to integers as usual (e.g., a DBP of 94.7 would be rounded to 95 mmHg and a DBP of 109.3 would be rounded to 109 mmHg). Participants between 18 and 80 years of age. Ability to provide written informed consent. 4.24 hour mean DBP >= 85 mmHg at visit 3. 5.Ability to stop any current antihypertensive therapy without risk to the patient (investigators discretion). Exclusion Criteria: Patients taking more than three anti-hypertensive medications at the screening visit. Pre-menopausal women (last menstruation <= 1 year prior to start of screening): Who are not surgically sterile (hysterectomy, tubal ligation). Who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study. Acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives. Any woman: Who has a positive urine pregnancy test at screening (Visit 1). Who is nursing. Hepatic and/or renal dysfunction as defined by the following laboratory parameters: SGPT(ALT) or SGOT(AST) greater than two times the upper limit of normal. Serum creatinine > 3.0 mg/dL (or 265 mmol/L) or creatinine clearance < 0.6 ml/sec. Clinically relevant hypokalaemia or hyperkalaemia. Uncorrected volume depletion. Uncorrected sodium depletion. Hereditary fructose intolerance. Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency. Known or suspected secondary hypertension. Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney. Congestive heart failure (NYHA functional class CHF III-IV refer to Appendix 11. 1). Unstable angina within the past three months. Stroke within the past six months. Myocardial infarction or cardiac surgery within the past three months. PTCA within the past three months. Patients who have previously experienced symptoms characteristic of angiodema during treatment with ACE inhibitor or angiotensin II receptor antagonists. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.

Sites / Locations

  • Shanghai Ruijin Hospital

Outcomes

Primary Outcome Measures

To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.

Secondary Outcome Measures

Smooth Index for DBP and SBP Change from the baseline in the ABPM endpoint: 24 hour mean, daytime mean , nighttime mean, morning mean, last 6-hours of the dosing interval mean SBP, DBP,MAP and HR.

Full Information

First Posted
November 22, 2005
Last Updated
November 8, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00257491
Brief Title
Study to Evaluate the Trough and Peak Effect of Once Daily Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg (Micardis Plus) by Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Essential Hypertension
Official Title
An Open-label Study to Evaluate the Trough and Peak Effect of Once Daily Micardis Plus (Telmisartan 80mg / Hydrochlorothiazide 12.5 mg) by 24 ABPM in Patients With Mild to Moderate Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
To evaluate the trough and peak effect of once daily MICARDIS PLUS (Telmisartan 80 mg/hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential hypertension.
Detailed Description
This study is designed as an open label study. After a 2-week placebo run-in phase, qualified patients will be administered with telmisartan 80mg for 2 weeks, then forcefully titrated to telmisartan 80 mg and hydrochlorothiazide 12.5 mg fixed dose combination for 6 weeks. 24 hour ABPM will be performed at the end of placebo run-in period (baseline) and after 8 weeks of active treatment. Study Hypothesis: The primary analyses will be the calculation of trough to peak ratios (T/P ratios) for DBP and SBP. The T/P ratio will be calculated on the basis of changes in hourly means (related to dosing time) from baseline (DeltaHM). Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. Thus, T/P is calculated as T/P = mean(DeltaHM22 - DeltaHM24)/min (DeltaHM2 - DeltaHM8). Comparison(s): To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in 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
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Telmisartan
Intervention Type
Drug
Intervention Name(s)
Telmisartan/HCTZ
Primary Outcome Measure Information:
Title
To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.
Secondary Outcome Measure Information:
Title
Smooth Index for DBP and SBP Change from the baseline in the ABPM endpoint: 24 hour mean, daytime mean , nighttime mean, morning mean, last 6-hours of the dosing interval mean SBP, DBP,MAP and HR.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of mild-to-moderate essential hypertension defined by a mean seated DBP >= 95 and <= 109 mmHg, and SBP < 180mmHg measured by manual cuff sphygmomanometer at visit 2. Note: The manual cuff value is calculated as the mean of three seated measurements collected 2 minutes apart, after the patient has been seated quietly for 5 minutes. For calculation of mean values by the investigator, decimal places should be rounded to integers as usual (e.g., a DBP of 94.7 would be rounded to 95 mmHg and a DBP of 109.3 would be rounded to 109 mmHg). Participants between 18 and 80 years of age. Ability to provide written informed consent. 4.24 hour mean DBP >= 85 mmHg at visit 3. 5.Ability to stop any current antihypertensive therapy without risk to the patient (investigators discretion). Exclusion Criteria: Patients taking more than three anti-hypertensive medications at the screening visit. Pre-menopausal women (last menstruation <= 1 year prior to start of screening): Who are not surgically sterile (hysterectomy, tubal ligation). Who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study. Acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives. Any woman: Who has a positive urine pregnancy test at screening (Visit 1). Who is nursing. Hepatic and/or renal dysfunction as defined by the following laboratory parameters: SGPT(ALT) or SGOT(AST) greater than two times the upper limit of normal. Serum creatinine > 3.0 mg/dL (or 265 mmol/L) or creatinine clearance < 0.6 ml/sec. Clinically relevant hypokalaemia or hyperkalaemia. Uncorrected volume depletion. Uncorrected sodium depletion. Hereditary fructose intolerance. Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency. Known or suspected secondary hypertension. Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney. Congestive heart failure (NYHA functional class CHF III-IV refer to Appendix 11. 1). Unstable angina within the past three months. Stroke within the past six months. Myocardial infarction or cardiac surgery within the past three months. PTCA within the past three months. Patients who have previously experienced symptoms characteristic of angiodema during treatment with ACE inhibitor or angiotensin II receptor antagonists. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim Shanghai
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.488_U08-3410.pdf
Description
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Study to Evaluate the Trough and Peak Effect of Once Daily Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg (Micardis Plus) by Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Essential Hypertension

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