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Telmisartan Effectiveness on Left Ventricular Mass Reduction (TELMAR) as Assessed by MRI, in Patients With Mild to Moderate Hypertension

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Telmisartan (Drug); Metoprolol succinate (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Boehringer Ingelheim


The primary objective was to show that telmisartan is not inferior to metoprolol succinate in respect of the percentage change from baseline in LVMI(H) after a 6. 5 months treatment period. As secondary objectives, the improvement in left ventricular systolic and diastolic function and blood pressure reduction were assessed

Clinical Details

Official title: 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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Percentage change in left ventricular mass index relative to height (LVMI(H))

Secondary outcome:

Number of patients with adverse events

Change of left ventricular mass index related to the body surface area (LVMI (BSA)) measured by MRI

Change of left ventricular end-systolic (LVESV) measured by MRI

Change of left ventricular end-diastolic volume (LVEDV) as measured by MRI

Change of left ventricular end-diastolic volume index related to height LVEDVI (H))

Change of left ventricular end-diastolic volume index related to the body mass index (LVEDVI (BSA))

Change of left ventricular ejection fraction (EF)

Change of end-systolic wall stress (ESWS) measured by MRI

Change of 24-hour mean systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)

Change of 24-hour mean diastolic blood pressure as measure by ABPM

Change of mean seated trough systolic blood pressure measured by manual cuff sphygmomanometer

Change of mean seated trough diastolic blood pressure measured by manual cuff sphygmomanometer


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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


- 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


- Clinically significant concomitant diseases:

- Hepatic and/or renal dysfunction as defined by the following laboratory

parameters: 1. 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 2. Serum creatinine > 150 mol/L

- Clinically significant sodium or potassium depletion, clinically relevant


- Uncorrected volume depletion

- Primary aldosteronism

- Hereditary fructose intolerance

- Biliary obstructive disorders, cholestasis or moderate to severe hepatic


- 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

Locations and Contacts

Additional Information

Starting date: September 2003
Last updated: September 16, 2014

Page last updated: August 23, 2015

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