Hypertension
Conditions
Brief summary
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.
Interventions
DRUGolmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
Tablets and capsules for oral administration once or twice daily for up to 52 weeks
DRUGatenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
Tablets and capsules for oral administration once or twice daily for up to 52 weeks
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of serum lipid and markers of atherosclerosis | 12 weeks |
| Retinal arteriole measurements | 52 weeks |
| Results of vascular function tests | 12 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 insulin sensitivity measurement | 12 Weeks |
Countries
United States
Outcome results
None listed