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

December 20, 2018 updated by: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks for each treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks for each treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

April 29, 2009

First Submitted That Met QC Criteria

April 30, 2009

First Posted (ESTIMATE)

May 1, 2009

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSE-866/46
  • 2007-003130-41 EudraCT number

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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