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OpenTrials
Completed

NCT Number: NCT00772499

Vascular Improvement With Olmesartan Medoxomil Study

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure

Drug

Tablets and capsules for oral administration once or twice daily for up to 52 weeks

atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure

Drug

Tablets and capsules for oral administration once or twice daily for up to 52 weeks

Primary outcomes

  1. Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy

    Time frame: 52 weeks

Secondary outcomes

  1. Results of vascular function tests

    Time frame: 12 weeks

  2. Results of vascular function tests

    Time frame: 28 weeks

  3. Results of vascular function tests

    Time frame: 52 weeks

  4. Measurement of serum lipid and markers of atherosclerosis

    Time frame: 12 weeks

  5. Measurement of serum lipid and markers of atherosclerosis

    Time frame: 28 weeks

  6. Measurement of serum lipid and markers of atherosclerosis

    Time frame: 52 weeks

  7. Retinal arteriole measurements

    Time frame: 52 weeks

  8. Calculation of insulin sensitivity measurement

    Time frame: 12 Weeks

  9. Calculation of insulin sensitivity measurement

    Time frame: 28 weeks

  10. Calculation of insulin sensitivity measurement

    Time frame: 52 weeks

  11. 24 hour urine creatinine and thromboxane B2 measurements

    Time frame: 12 weeks

  12. Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio

    Time frame: 12 weeks

  13. Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio

    Time frame: 28 weeks

  14. Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Acronym: VIOS

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Oct 15, 2008
Registry last updated
Oct 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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