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

Primary Purpose

Metabolic Syndrome, Hypertension

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Olmesartan medoxomil tablets low dose
Olmesartan medoxomil tablets high dose
Amlodipine
Sponsored by
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Inflammatory markers, Vascular protection, OM Effect, Metabolic syndrome, Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Olmesartan medoxomil low dose

Olmesartan medoxomil tablets high dose

Amlodipine

Arm Description

Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks

Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks

Amlodipine taken once daily for 6 weeks

Outcomes

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

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)

Full Information

First Posted
April 29, 2009
Last Updated
December 20, 2018
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
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1. Study Identification

Unique Protocol Identification Number
NCT00891267
Brief Title
Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
Acronym
VAMOS
Official Title
Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Hypertension
Keywords
Inflammatory markers, Vascular protection, OM Effect, Metabolic syndrome, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olmesartan medoxomil low dose
Arm Type
Experimental
Arm Description
Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
Arm Title
Olmesartan medoxomil tablets high dose
Arm Type
Experimental
Arm Description
Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
Arm Title
Amlodipine
Arm Type
Active Comparator
Arm Description
Amlodipine taken once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil tablets low dose
Intervention Description
Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil tablets high dose
Intervention Description
Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
Amlodipine tablets taken once daily for 6 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
City
Erlangen
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

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

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