Vascular Improvement With Olmesartan Medoxomil Study
Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure (Drug); atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Daiichi Sankyo Inc.
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.
Clinical Details
Official title: Vascular Improvement With Olmesartan Medoxomil Study
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy
Secondary outcome: Results of vascular function testsResults of vascular function tests Results of vascular function tests Measurement of serum lipid and markers of atherosclerosis Measurement of serum lipid and markers of atherosclerosis Measurement of serum lipid and markers of atherosclerosis Retinal arteriole measurements Calculation of insulin sensitivity measurement Calculation of insulin sensitivity measurement Calculation of insulin sensitivity measurement 24 hour urine creatinine and thromboxane B2 measurements Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157, United States
Additional Information
Starting date: November 2002
Last updated: October 14, 2008
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