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

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ClinicalTrials.gov Identifier: NCT00891267
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : December 24, 2018
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Metabolic Syndrome Hypertension Drug: Olmesartan medoxomil tablets low dose Drug: Olmesartan medoxomil tablets high dose Drug: Amlodipine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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
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Germany
Erlangen, Germany
Sponsors and Collaborators
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

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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 Posted: May 1, 2009    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: May 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Keywords provided by Daiichi Sankyo, Inc.:
Inflammatory markers
Vascular protection
OM Effect
Metabolic syndrome
Hypertension
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Hypertension
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists