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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan | Experimental | MICARDIS® |
|
| Metoprolol succinate | Active Comparator | BELOC ZOK® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
| ||
| Metoprolol succinate |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in left ventricular mass index relative to height (LVMI(H)) | based on LVM measurements by magnetic resonance imaging (MRI) | Baseline, day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | up to 6.5 months | |
| Change of left ventricular mass index related to the body surface area (LVMI (BSA)) measured by MRI | Baseline, day 180 | |
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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:
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 on ethical grounds:
General Contraindications:
Clinically significant concomitant diseases:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
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:
Specific exclusion for the disease under study:
Specific concomitant therapy exclusions:
Participation in another drug trial
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Placebo | Drug |
|
| Change of left ventricular end-systolic (LVESV) measured by MRI |
| Baseline, day 180 |
| Change of left ventricular end-diastolic volume (LVEDV) as measured by MRI | Baseline, day 180 |
| Change of left ventricular end-diastolic volume index related to height LVEDVI (H)) | 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)) | based on LV volumetric measurements by MRI | Baseline, day 180 |
| Change of left ventricular ejection fraction (EF) | based on LV volumetric measurements by MRI | Baseline, day 180 |
| Change of end-systolic wall stress (ESWS) measured by MRI | Baseline, day 180 |
| Change of 24-hour mean systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) | Baseline, day 179 |
| Change of 24-hour mean diastolic blood pressure as measure by ABPM | Baseline, day 179 |
| Change of mean seated trough systolic blood pressure measured by manual cuff sphygmomanometer | up to day 194 |
| Change of mean seated trough diastolic blood pressure measured by manual cuff sphygmomanometer | up to day 194 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |