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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vascular Improvement With Olmesartan Medoxomil Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: November 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772499

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Director Medical Research, Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00772499     History of Changes
Other Study ID Numbers: 866-432
Study First Received: October 13, 2008
Last Updated: October 14, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Olmesartan medoxomil
Hydralazine
Hydrochlorothiazide
Amlodipine
Olmesartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Calcium Channel Blockers

ClinicalTrials.gov processed this record on May 21, 2013