Vascular Improvement With Olmesartan Medoxomil Study

Study Overview
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Brief Summary
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The purpose of this study is to compare in patients with primary hypertension, the non-blood pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol on changes in the vascular structure and function.

Official Title
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Vascular Improvement With Olmesartan Medoxomil Study

Conditions
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Hypertension

Intervention / Treatment
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* Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
* Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18-75 years of age Mean seated diastolic BP 90-109 or mean seated systolic BP of 140-179 Exclusion Criteria: Secondary hypertension Renal disease Diabetes mellitus Serum creatinine >3.0 mg/dL Hemoglobin <10 mg/dL (males) or <9mg/dL (females) WBC count <2000 cells/mL Platelet count <100,000 cells/mL Either ALT & AST >2.5 x upper limit of normal BMI >35 kg/m2 TIA or cerebrovascular attack within 3 months of study entry

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>olmesartan medoxomil tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure | Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure<br>* Tablets and capsules for oral administration once or twice daily for up to 52 weeks<br>|
| Active Comparator: 2<br>Atenolol tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure | Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure<br>* Tablets and capsules for oral administration once or twice daily for up to 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of vascular function tests |  | 12 weeks | 
| Results of vascular function tests |  | 28 weeks | 
| Results of vascular function tests |  | 52 weeks | 
| Measurement of serum lipid and markers of atherosclerosis |  | 12 weeks | 
| Measurement of serum lipid and markers of atherosclerosis |  | 28 weeks | 
| Measurement of serum lipid and markers of atherosclerosis |  | 52 weeks | 
| Retinal arteriole measurements |  | 52 weeks | 
| Calculation of insulin sensitivity measurement |  | 12 Weeks | 
| Calculation of insulin sensitivity measurement |  | 28 weeks | 
| Calculation of insulin sensitivity measurement |  | 52 weeks | 
| 24 hour urine creatinine and thromboxane B2 measurements |  | 12 weeks | 
| Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio |  | 12 weeks | 
| Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio |  | 28 weeks | 
| Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio |  | 52 weeks |