Essential hypertension in subjects with documented carotid atherosclerosis MedDRA version: 12.0 Level: PT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Trade Name: Olmetec 20mg film-coated tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OLMESARTAN MEDOXOMIL
CAS Number: 144689-63-4
Current Sponsor code: OM
Other descriptive name: O
Sponsors
DAIICHI SANKYO EUROPE GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female Caucasian outpatients aged > 40 years. 2. High BP defined as mean SeSBP/SeDBP = 140/90 mmHg. 3. One or more of the following additional risk factors: • Smoking; • Dyslipidaemia (high-density lipoprotein (HDL)-cholesterol 2.6 mmol/L, or triglycerides > 1.7 mmol/L); • Left ventricular hypertrophy; • Cardiocerebrovascular events > 6 months ago; • Presence of target organ damage. 4. Non-calcified (not marked shadowing) plaque in the CC artery, in the internal carotid artery or the carotid bulb with a PV = 0.040 cm³ (= 40 µL) according to the measurements of EUTARC. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Secondary or high grade hypertension including grade III hypertension (SeSBP of > 180 mmHg or SeDBP of > 105 mmHg). 2. Stroke, myocardial infarction within the previous 6 months. 3. Interventional or surgical vascular treatment within the previous 3 months. 4. Presence of significant narrowing of the aortic or bicuspid valve and severe obstruction of cardiac outflow (hypertrophic cardiomyopathy). 5. Symptomatic heart failure. 6. Diabetes. 7. Chronic obstructive pulmonary disease (COPD) or asthma. 8. Claudicatio intermittens stage II b or higher. 9. Clinical evidence of severe renal disease [including renovascular occlusive disease, nephrectomy and/or renal transplant, creatinine clearance of 300 mg albumin/24 hours or 300 µg albumin/mg creatinine)]. 10. Treatment with angiotensin converting enzyme (ACE)-inhibitors or angiotensin-receptor blockers (ARBs) during last 3 months. 11. Start of treatment with a lipid-lowering agent or modification of dosage within last 3 months. 12. Electrocardiographic (ECG) evidence of 2nd or 3rd degree atrioventricular (AV) block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia ( 75%. 17. Plaque with marked shadowing from calcification. 18. Target plaques in CC artery extending into both internal and external arteries. 19. Pregnant or lactating female subjects. 20. Female subjects of childbearing potential without adequate contraception: intra-uterine devices, hormonal contraceptives, either oral, depot, patch or injectable and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. If a female becomes pregnant during the trial, she has to be withdrawn immediately. 21. Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents. 22. Subject has previously entered this study. 23. Subjects who have received ATE within 30 days prior to entering the active treatment phase. 24. Subjects who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period. 25. Subjects with history of alcohol and or drug abuse. 26. Subjects with known malabsorption syndrome. 27. Subjects who had donated or lost 450 mL or more blood during the last three months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of OM and ATE on changes of carotid plaque volume (PV) as assessed by 3-D ultrasonography after 78 weeks of treatment compared to baseline.;Secondary Objective: Secondary objectives are to: •Compare the effect of OM and ATE on changes of PV from baseline to Week 52. •Compare the effect of OM and ATE on percentage changes of PV from baseline to Week 52 and to Week 78. •Compare the effect of OM and ATE on changes in seated diastolic blood pressure (SeDBP) and seated systolic blood pressure (SeSBP) from baseline to Week 52 and to Week 78. •Compare the effect of OM and ATE on changes of PV from baseline to Week 52 and to Week 78 after adjustments for changes in SeDBP and SeSBP from baseline. •Assess safety and tolerability of OM and ATE during the study. ;Primary end point(s): The primary efficacy variable is the change in PV from baseline as assessed by 3-D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily. Secondary efficacy variables: • Change from baseline PV at Week 52. • Percent change from baseline PV at Week 52 and at Week 78. • Change from baseline SeDBP and SeSBP at Week 52 and at Week 78. • Change from baseline PV after adjustment for change in SeDBP and SeSBP at Week 52 and at Week 78. Exploratory efficacy variables: • Change from baseline IMT of the CC artery of the leading and less affected side at Week 52 and at Week 78. • Change from baseline in overall mean IMT (i.e. mean IMT of both carotids) at Week 52 and at Week 78. • Change from baseline LD of the CC artery measured at end-diastole at Week 52 and at Week 78. • Change from baseline cross-sectional area of IMT (CSA-IMT) calculated as CSA-IMT=p x IMT x (IMT+LD) at Week 52 and at Week 78. • Change in frequencies of the two categories of PV (2 groups based on median value) between baseline and Week 52 and Week 78, respectively. • Percentage change from baseline in plaque echogenicity at Week 52 and at | — |
Countries
Belgium, Czech Republic, Germany, Italy, Netherlands
Outcome results
None listed