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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 264

Inclusion Criteria

Subjects must satisfy all of the following criteria at Screening visit (Visit 1) and at Baseline (Visit 2) to be included in the study; except inclusion criterion 3, which needs only be satisfied at the screening visit:

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 with modifications, as:
a) BP = 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or low range” mild hypertension) and at least 1 of the following traits:
• Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
• Triglyceride level = 150 mg/dL (= 1.7 mmol/L)
• HDL < 40 mg/dL for men and < 50 mg/dL for women
• Fasting blood glucose = 110 mg/dL (= 6.1 mmol/L) and < 126 mg/dL (< 7 mmol/L) (ie no type 2 diabetes)
Or
b) BP = 120/80 mmHg and < 130/85 mmHg (ie normal BP) and one antihypertensive treatment at Screening, and normal to low range” mild hypertension (ie = 130/85 and < 150/95 mmHg) at Baseline, and at least 1 of the following traits:
• Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
• Triglyceride level = 150 mg/dL (= 1.7 mmol/L)
• HDL < 40 mg/dL for men and < 50 mg/dL for women
• Fasting blood glucose = 110 mg/dL (= 6.1 mmol/L) and < 126 mg/dL (< 7 mmol/L) (ie no type 2 diabetes)
Or
c) BP = 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or low range” mild hypertension) and current treatment with a lipid-lowering agent and at least 1 of the following traits:
• Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
• Fasting blood glucose = 110 mg/dL (= 6.1 mmol/L) and < 126 mg/dL (< 7 mmol/L) (ie no type 2 diabetes)
4. No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months (including ACE, ARB and renin-inhibitors).
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

Subjects who meet any of the following criteria at Screening visit (Visit 1) or at Baseline (Visit 2) will be disqualified from entering the study:

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. 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
7. 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
8. Clinically relevant abnormal laboratory values
9. Contraindication to OM
10. Previously screened subjects, unless they failed inclusion criterion 3 at screening and/or baseline under earlier protocol requirements.
11. Alcohol or drug of abuse in the past 2 years
12. Planned hospitalization during the study period
13. Participation in any other clinical study within 30 days prior to Screening visit
14. 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

Secondary Outcome Measures

Name	Time	Method

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