Vascular Improvement With Olmesartan Medoxomil Study (VIOS)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure; Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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; Tablets and capsules for oral administration once or twice daily for up to 52 weeks
Active Comparator: 2; 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; Tablets and capsules for oral administration once or twice daily for up to 52 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): July 1, 2005
• Study Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: October 13, 2008
• First Submitted That Met QC Criteria: October 14, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Estimate): October 15, 2008
• Last Update Submitted That Met QC Criteria: October 14, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Amlodipine; Olmesartan; Olmesartan Medoxomil; Hydrochlorothiazide; Atenolol; Hydralazine
• Other Study ID Numbers: 866-432