- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242812
Telmisartan Effectiveness on Left Ventricular Mass Reduction (TELMAR) as Assessed by MRI, in Patients With Mild to Moderate Hypertension
Telmisartan Effectiveness on Left Ventricular MAss Reduction (TELMAR) as Assessed by MRI, in Patients With Mild to Moderate Hypertension - a Prospective, Randomised, Double-blind Comparison of Telmisartan 80 mg Oral, Once Daily, to Metoprolol Succinate 95 mg Oral, Once Daily, Over a Period of 6 Months
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Caucasian and non-Caucasian patients i.e. Asian patients with untreated essential hypertension as defined by either a mean systolic blood pressure (SBP) of >= 140 mm Hg or a mean diastolic blood pressure (DBP) of >= 90 mm Hg during normal daily activities (6:00 - 21:59 h) and/or a nocturnal (22:00 - 05:59 h) SBP mean of >= 120 mm Hg or a DBP mean of >= 70 mm Hg as measured by ABPM.
Presence of Left Ventricular Hypertrophy (LVH) as defined by MRI:
- Caucasian patients: Left ventricular mass of > 0.8 g/cm for women or > 1.05 g/cm for men. Non-Caucasian i.e. Asian patients: Left ventricular mass of > 0.65 g/cm for women or > 0.85 g/cm for men
- Age between 18 and 80 years
- Written informed consent in accordance with Good Clinical Practice (GCP) guidelines and the local regulatory and legal requirements
Exclusion Criteria:
Contraindications to the class of drugs under study:
- Contraindications against β Blocker or angiotensin receptor antagonists
- A history of angioedema or known hypersensitivity to any component of the formulations
Contraindications on ethical grounds:
- there are no specific contraindications ethical grounds foreseen in this study
General Contraindications:
- Pregnancy, lactation or child bearing potential (I.e. Pre-menopausal women (last menstruation < 1 year prior to start of run-in phase) who are not surgically sterile (hysterectomy, tubal ligation) or who are NOR practicing or do NOT plan to practice acceptable means of birth control (Intrauterine Device, oral implantable or injectable contraceptives) or who have a positive serum pregnancy test at screening or baseline)
- Factors making follow up difficult (i.e. no fixed address)
- Treatment with other investigational drugs within one month of signing informed consent
Clinically significant concomitant diseases:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- Alanine amino transferase (SGPT (ALT)) or Aspartate amino transferase (SGOT (AST)) values above two times or Gamma glutaryl transferase (Gamma-GT) three times the upper normal limit
- Serum creatinine > 150 mol/L
- Clinically significant sodium or potassium depletion, clinically relevant hyperkalaemia
- Uncorrected volume depletion
- Primary aldosteronism
- Hereditary fructose intolerance
- Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency
- Insulin-dependent diabetes mellitus
- Congestive heart failure or ejection fraction < 35% New York Heart Association (NYHA) class III or IV
- Unstable Angina
- Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
- Post-renal transplant patients
- Myocardial infarction or cardiac surgery within the preceding six months
- Known drug or alcohol abuse within 6 months prior to start of study
Patients with MRI contraindications:
- Implanted pacemaker or defibrillator
- Implanted vascular clips
- Gross obesity (i.e. patients weight > 150 kg)
Specific exclusion for the disease under study:
- Known or suspected secondary hypertension
- Known renal artery stenosis
- Known endocrine disorders with secondary hypertension
- Severe arterial hypertension as defined by a mean seated DBP > 115 mmHg or a mean seated SBP > 200 mmHg
- Patients with a complete loss of diurnal BP variation, as defined by the lack of drop of BP during sleeping time or a drop of less than 5% when compared to daily mean BP
- Hypertrophic obstructive cardiomyopathy, clinically relevant aortic valve stenosis or clinically relevant mitral valve disease; vascular disease affecting BP (coarctation; stenosis of A. subclavia)
Specific concomitant therapy exclusions:
- Use of antihypertensive medication within the previous six months
- Chronic administration of digoxin or other digitalis-type drugs, without regular monitoring of plasma level
- Chronic administration of any medications known to affect blood pressure, except medications allowed by the protocol
- Continuous (for more than two weeks) treatment within the last three months using at least on of the following drugs: β blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers
- Participation in another drug trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telmisartan
MICARDIS®
|
|
Active Comparator: Metoprolol succinate
BELOC ZOK®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage change in left ventricular mass index relative to height (LVMI(H))
Time Frame: Baseline, day 180
|
based on LVM measurements by magnetic resonance imaging (MRI)
|
Baseline, day 180
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with adverse events
Time Frame: up to 6.5 months
|
up to 6.5 months
|
|
Change of left ventricular mass index related to the body surface area (LVMI (BSA)) measured by MRI
Time Frame: Baseline, day 180
|
Baseline, day 180
|
|
Change of left ventricular end-systolic (LVESV) measured by MRI
Time Frame: Baseline, day 180
|
Baseline, day 180
|
|
Change of left ventricular end-diastolic volume (LVEDV) as measured by MRI
Time Frame: Baseline, day 180
|
Baseline, day 180
|
|
Change of left ventricular end-diastolic volume index related to height LVEDVI (H))
Time Frame: Baseline, day 180
|
based on LV volumetric measurements by MRI
|
Baseline, day 180
|
Change of left ventricular end-diastolic volume index related to the body mass index (LVEDVI (BSA))
Time Frame: Baseline, day 180
|
based on LV volumetric measurements by MRI
|
Baseline, day 180
|
Change of left ventricular ejection fraction (EF)
Time Frame: Baseline, day 180
|
based on LV volumetric measurements by MRI
|
Baseline, day 180
|
Change of end-systolic wall stress (ESWS) measured by MRI
Time Frame: Baseline, day 180
|
Baseline, day 180
|
|
Change of 24-hour mean systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)
Time Frame: Baseline, day 179
|
Baseline, day 179
|
|
Change of 24-hour mean diastolic blood pressure as measure by ABPM
Time Frame: Baseline, day 179
|
Baseline, day 179
|
|
Change of mean seated trough systolic blood pressure measured by manual cuff sphygmomanometer
Time Frame: up to day 194
|
up to day 194
|
|
Change of mean seated trough diastolic blood pressure measured by manual cuff sphygmomanometer
Time Frame: up to day 194
|
up to day 194
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Metoprolol
- Telmisartan
Other Study ID Numbers
- 502.393
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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