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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
  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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vascular Improvement With Olmesartan Medoxomil Study

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Results of vascular function tests [ Time Frame: 12 weeks ]
  • Results of vascular function tests [ Time Frame: 28 weeks ]
  • Results of vascular function tests [ Time Frame: 52 weeks ]
  • Measurement of serum lipid and markers of atherosclerosis [ Time Frame: 12 weeks ]
  • Measurement of serum lipid and markers of atherosclerosis [ Time Frame: 28 weeks ]
  • Measurement of serum lipid and markers of atherosclerosis [ Time Frame: 52 weeks ]
  • Retinal arteriole measurements [ Time Frame: 52 weeks ]
  • Calculation of insulin sensitivity measurement [ Time Frame: 12 Weeks ]
  • Calculation of insulin sensitivity measurement [ Time Frame: 28 weeks ]
  • Calculation of insulin sensitivity measurement [ Time Frame: 52 weeks ]
  • 24 hour urine creatinine and thromboxane B2 measurements [ Time Frame: 12 weeks ]
  • Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio [ Time Frame: 12 weeks ]
  • Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio [ Time Frame: 28 weeks ]
  • Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio [ Time Frame: 52 weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Olmesartan
Amlodipine
Olmesartan Medoxomil
Hydrochlorothiazide
Atenolol
Hydralazine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on June 23, 2017