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Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome (VAMOS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00891267
First Posted: May 1, 2009
Last Update Posted: May 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Daiichi Sankyo, Inc.
  Purpose
The purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome.

Condition Intervention Phase
Metabolic Syndrome Hypertension Drug: Olmesartan medoxomil tablets low dose Drug: Olmesartan medoxomil tablets high dose Drug: Amlodipine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • To investigate the anti-inflammatory effect of Olmesartan (OM) higher dose compared to Olmesartan (OM) lower dose and amlodipine (AML) on the change in levels of the inflammatory marker hs-CRP [ Time Frame: 6 weeks for each treatment ]

Secondary Outcome Measures:
  • To evaluate the additional antihypertensive efficacy in blood pressure (BP) lowering, assessed by conventional BP measurement and 24-h ambulatory BP measurement (24-h ABPM) [ Time Frame: 6 weeks for each treatment ]

Estimated Enrollment: 60
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olmesartan medoxomil low dose
Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
Drug: Olmesartan medoxomil tablets low dose
Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
Experimental: Olmesartan medoxomil tablets high dose
Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
Drug: Olmesartan medoxomil tablets high dose
Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
Active Comparator: Amlodipine
Amlodipine taken once daily for 6 weeks
Drug: Amlodipine
Amlodipine tablets taken once daily for 6 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation
  • Blood pressure greater than or equal to 130/85 mmHg AND
  • hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria):
  • abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women;
  • triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women
  • fasting blood glucose greater than or equal to 110mg/dL

Exclusion Criteria:

  • Insulin depended diabetes or type-1 diabetes
  • Severe or resistant hypertension
  • Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
  • Any acute or chronic inflammatory disease
  • Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start
  • Pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception);
  • Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891267


Locations
Germany
Erlangen, Germany
Sponsors and Collaborators
Daiichi Sankyo Europe, GmbH
  More Information

Responsible Party: Senior Manager Clinical Development, Daiichi Sankyo Europe
ClinicalTrials.gov Identifier: NCT00891267     History of Changes
Other Study ID Numbers: DSE-866/46
2007-003130-41 EudraCT number
First Submitted: April 29, 2009
First Posted: May 1, 2009
Last Update Posted: May 25, 2011
Last Verified: May 2011

Keywords provided by Daiichi Sankyo, Inc.:
Inflammatory markers
Vascular protection
OM Effect
Metabolic syndrome
Hypertension

Additional relevant MeSH terms:
Syndrome
Hypertension
Metabolic Syndrome X
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Olmesartan
Amlodipine
Olmesartan Medoxomil
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists