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Vascular Improvement With Olmesartan Medoxomil Study (VIOS)

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00772499
First received: October 13, 2008
Last updated: October 14, 2008
Last verified: October 2008

October 13, 2008
October 14, 2008
November 2002
July 2005   (final data collection date for primary outcome measure)
Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00772499 on ClinicalTrials.gov Archive Site
  • Results of vascular function tests [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Results of vascular function tests [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Results of vascular function tests [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Measurement of serum lipid and markers of atherosclerosis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Measurement of serum lipid and markers of atherosclerosis [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Measurement of serum lipid and markers of atherosclerosis [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Retinal arteriole measurements [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Calculation of insulin sensitivity measurement [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Calculation of insulin sensitivity measurement [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Calculation of insulin sensitivity measurement [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 24 hour urine creatinine and thromboxane B2 measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vascular Improvement With Olmesartan Medoxomil Study
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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
  • 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
  • Experimental: 1
    olmesartan medoxomil tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure
    Intervention: Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
  • Active Comparator: 2
    Atenolol tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure
    Intervention: Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2005
July 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00772499
866-432
No
Director Medical Research, Daiichi Sankyo, Inc.
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP