Atherosclerotic Cardiovascular Disease, Essential Hypertension
Conditions
Brief summary
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.
Interventions
DRUGOlmesartan medoxomil
DRUGAtenolol
DRUGHydrochlorothiazide
tablets
DRUGolmesartan medoxomil
tablets
DRUGatenolol
tablets
Sponsors
Sankyo Pharma Gmbh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Mean sitting sBP and dBP prior to randomization of 140-180/90-105 mmHg * Increased cardiovascular risk, e.g.: a) documented or clinical signs of peripheral atherosclerotic disease stage IIa or lower; b) diabetes mellitus type 2; c) left ventricular hypertrophy on echo; d) current smoking; e) old myocardial infarction, stroke or TIA * Intima-media thickness of the common carotid artery greater than or equal to 0.8 and less than or equal to 1.6 mm (measured ultrasonographically) or the plaque volume of the carotid bulb greater than or equal to 4 μl and less than or equal to 500 μl
Exclusion criteria
* Body mass index \> 30 * Any type of known secondary hypertension * Electrocardiographic evidence of 2nd or 3rd degree atrioventricular block, atrial fibrillation, cardiac arrhythmia requiring therapy or bradycardia at rest (\< 50/min) * Obstructive pulmonary disease * Claudicatio intermittens * History or clinical evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial * Hypersensitivity or contraindication to ARBs, Beta-Blockers, HCTZ or any cross allergy * Pre-treatment with ARBs or ACE inhibitors within 6 months prior to screening * Treatment with disallowed medication * Pregnant or breastfeeding females or females of childbearing potential without adequate contraception * History of alcohol and/or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of intima media thickness of the common carotid artery on the leading side of the neck. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in plaque volume in the common carotid artery or the carotid bulb. | — |
| -Change of intima media thickness of the common carotid artery. | — |
| -Changes of diastolic and systolic blood pressure. | — |
| -Safety and tolerability | — |
Countries
Germany
Outcome results
None listed