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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:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00891267
First received: April 29, 2009
Last updated: May 24, 2011
Last verified: May 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891267

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

No publications provided

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
Study First Received: April 29, 2009
Last Updated: May 24, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on May 16, 2013