Vascular Improvement With Olmesartan Medoxomil Study

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure; Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure

• Registration Number: NCT00772499
• Lead Sponsor: Daiichi Sankyo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Status Verified: 2008-10
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-14
• Last Update Submitted: 2008-10-14
• Study First Posted: 2008-10-15
• Last Update Posted: 2008-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure	Atenolol tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure
1	olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure	olmesartan medoxomil tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure

Primary Outcome Measures

Name	Time	Method
Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy	52 weeks

Secondary Outcome Measures

Name	Time	Method
Results of vascular function tests	52 weeks
Measurement of serum lipid and markers of atherosclerosis	52 weeks
Retinal arteriole measurements	52 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	52 weeks

Trial Locations

Locations (1)

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States