Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects with Metabolic Syndrome

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

1. Male and female outpatients
2. Age = 18 and = 75 years
3. Hypertension and metabolic syndrome defined, according to the ATP III/ IDF 2005 and ESH/ESC 2007 definitions, as BP = 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or low range” mild hypertension) and at least 2 of the following traits at:
• Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
• Triglyceride level = 150 mg/dL
• High Density Lipoprotein (HDL) < 40 mg/dL for men and < 50 mg/dL for women
•Fasting blood glucose = 110 mg/dL and < 126 mg/dL (ie no type 2 diabetes)
4. No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months. Note: treatment with Angiotensin II Receptor Blockers (ARB) or Angiotensin-Converting Enzyme Inhibitors (ACE) is not allowed within the last 6 months
5. Signature of the Informed Consent Form (ICF)

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

1. Pregnant or lactating female (prerequisite for female subjects of childbearing potential: adequate contraception)
2. Type 1 and type 2 diabetes
3. High range” mild hypertension (ie Systolic Blood Pressure [SBP]: 150 - < 160 mmHg and/or Diastolic Blood Pressure [DBP]: 95 - < 100 mmHg)
4. Moderate, severe, or resistant hypertension (see definitions below)
SBP (mmHg)DBP (mmHg)
Moderate hypertension160 – 179and/or100 – 109
Severe hypertension= 180and/or= 110
Resistant hypertensionHypertension resistant to treatment
5. Secondary hypertension of any aetiology, such as renal disease, pheocromocytoma, or Cushing’s syndrome
6. Inconsistent use of lipid-lowering agents (eg statins, fibrates) within 2 years prior to study start. Note: No use of lipid-lowering agents within 2 years is allowed.
7. Serious disorders which may limit the ability to evaluate the efficacy or safety of the study drug, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine, metabolic, haematological, oncological, neurological, or psychiatric diseases
8. History of the following pathologies within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, stroke, or transient ischemic attack
9. Clinically relevant abnormal laboratory values
10. Contraindication to OM
11. Previously enrolled subjects
12. Alcohol or drug of abuse in the past 2 years
13. Planned hospitalization during the study period
14. Participation in any other clinical study within 30 days prior to Screening visit
15. Enrolment of the Investigator(s), site staff, or their family members

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Primary efficacy endpoint<br>Mean change in carotid-femoral PWV.<br>;Main Objective: To investigate the dose-dependent effect of OM 20 mg, 40 mg, and 80 mg on aortic stiffness assessed by:<br>• The carotid-femoral Pulse Wave Velocity (PWV), up to 1 year of double-blind treatment<br>• The carotid-femoral PWV, after adjustment for reduction of mean blood pressure (MBP) as measured at the same visit (up to 1 year of double-blind treatment);Secondary Objective: To evaluate the dose-dependent effect of OM 20 mg, 40 mg, and 80 mg up to 1 year of double-blind treatment:<br>• On Blood Pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM).<br>• On central pulse pressure (PP) and augmentation index (AI).<br>• On common carotid artery stiffness, intima-media thickness (IMT), and internal diameter.<br>

Secondary Outcome Measures

Name	Time	Method

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