Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection

Study Overview
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Brief Summary
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This study will analyse the dose-dependent effect of olmesartan medoxomil on the change in arterial stiffness in subjects with hypertension and metabolic syndrome

Official Title
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Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome

Conditions
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Metabolic Syndrome, Hypertension

Intervention / Treatment
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* Drug: olmesartan medoxomil
* Drug: placebo
* Drug: olmesartan medoxomil
* Drug: olmesartan medoxomil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female outpatients Age greater than or equal to 18 years and less than or equal to 75 years Hypertension and metabolic syndrome defined, according to the ATP III/IDF 2005 and ESH/ESC 2007 definitions, as BP greater than or equal to 130/85 mmHg and <150/95 mmHg (i.e. 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 greater than or equal to 150 mg/dL High density lipoprotein (HDL) <40 mg/dL for men and <50 mg/dL for women Fasting blood glucose greater than or equal to 110 mg/dL and <126 mg/dL (i.e. no type 2 diabetes) 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. Exclusion Criteria: Pregnant or lactating female (prerequisite for female subjects of childbearing potential: adequate contraception) Type 1 and type 2 diabetes High range mild hypertension (i.e. systolic blood pressure [SBP]: 150 - <160 mmHg and /or diastolic blood pressure [DBP]: 95 - <100 mmHg) Moderate (SBP: 160 - 179 mmHg and DBP: 100 - 109 mmHg), severe (SBP: greater than or equal to 180 mmHg and/or greater than or equal to 110 mmHg), or resistant (hypertension resistant to treatment)hypertension Secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>A 3-week placebo run-in period. | Drug: placebo<br>* dosage form: tablet; frequency: daily; duration: 3 weeks<br>|
| Experimental: 2<br>Olmesartan medoxomil oral tablets, at lowest study dosage for 52-week double-blind treatment period | Drug: olmesartan medoxomil<br>* dosage form: oral tablet; frequency: daily; duration: 52 weeks<br>|
| Experimental: 3<br>Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 48 weeks. | Drug: olmesartan medoxomil<br>* dosage form: oral tablet; frequency: daily; duration: 52 weeks<br>|
| Experimental: 4<br>Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 4 weeks followed by the highest study dose for 44 weeks. | Drug: olmesartan medoxomil<br>* dosage form: oral tablet; frequency: daily; duration: 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in carotid-femoral pulse wave velocity (PWV) |  | Up to 1 year of double-blind treatment | 
| The change from baseline in carotid-femoral PWV, after adjustment for change from baseline in mean blood pressure (MBP)as measured at the same visit |  | Up to 1 year of double-blind treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On blood pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM) |  | Up to 1 year of double-blind treatment | 
| On central pulse pressure (PP) and augmentation index (AI) |  | Up to 1 year of double-blind treatment | 
| On common carotid stiffness, intima-media thickness (IMT), and internal diameter |  | Up to 1 year of double-blind treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arterial stiffness, Vascular protection