Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome.

Official Title
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Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

Conditions
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Metabolic Syndrome, Hypertension

Intervention / Treatment
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* Drug: Olmesartan medoxomil tablets low dose
* Drug: Olmesartan medoxomil tablets high dose
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation Blood pressure greater than or equal to 130/85 mmHg AND hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria): abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women; triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women fasting blood glucose greater than or equal to 110mg/dL Exclusion Criteria: Insulin depended diabetes or type-1 diabetes Severe or resistant hypertension Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome Any acute or chronic inflammatory disease Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start Pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception); Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s)

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olmesartan medoxomil low dose<br>Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks | Drug: Olmesartan medoxomil tablets low dose<br>* Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks<br>|
| Experimental: Olmesartan medoxomil tablets high dose<br>Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks | Drug: Olmesartan medoxomil tablets high dose<br>* Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks<br>|
| Active Comparator: Amlodipine<br>Amlodipine taken once daily for 6 weeks | Drug: Amlodipine<br>* Amlodipine tablets taken once daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the anti-inflammatory effect of Olmesartan (OM) higher dose compared to Olmesartan (OM) lower dose and amlodipine (AML) on the change in levels of the inflammatory marker hs-CRP |  | 6 weeks for each treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the additional antihypertensive efficacy in blood pressure (BP) lowering, assessed by conventional BP measurement and 24-h ambulatory BP measurement (24-h ABPM) |  | 6 weeks for each treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory markers, Vascular protection, OM Effect, Metabolic syndrome, Hypertension