Vascular Improvement With Olmesartan Medoxomil Study
VIOS
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
Started Nov 2002
Typical duration for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 13, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedOctober 15, 2008
October 1, 2008
2.7 years
October 13, 2008
October 14, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy
52 weeks
Secondary Outcomes (14)
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
- +9 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALolmesartan medoxomil tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure
2
ACTIVE COMPARATORAtenolol tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure
Interventions
Tablets and capsules for oral administration once or twice daily for up to 52 weeks
Tablets and capsules for oral administration once or twice daily for up to 52 weeks
Eligibility Criteria
You may qualify if:
- Male or female
- years of age
- Mean seated diastolic BP 90-109 or mean seated systolic BP of 140-179
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (1)
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 13, 2008
First Posted
October 15, 2008
Study Start
November 1, 2002
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
October 15, 2008
Record last verified: 2008-10