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

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.
 
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.

Tracking Information
First Submitted Date  ICMJE April 29, 2009
First Posted Date  ICMJE May 1, 2009
Last Update Posted Date December 24, 2018
Study Start Date  ICMJE October 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00891267 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
Official Title  ICMJE Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolic Syndrome
  • Hypertension
Intervention  ICMJE
  • Drug: Olmesartan medoxomil tablets low dose
    Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
  • Drug: Olmesartan medoxomil tablets high dose
    Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
  • Drug: Amlodipine
    Amlodipine tablets taken once daily for 6 weeks
Study Arms  ICMJE
  • Experimental: Olmesartan medoxomil low dose
    Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
    Intervention: Drug: Olmesartan medoxomil tablets low dose
  • Experimental: Olmesartan medoxomil tablets high dose
    Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
    Intervention: Drug: Olmesartan medoxomil tablets high dose
  • Active Comparator: Amlodipine
    Amlodipine taken once daily for 6 weeks
    Intervention: Drug: Amlodipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 30, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00891267
Other Study ID Numbers  ICMJE DSE-866/46
2007-003130-41 EudraCT number
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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/
Responsible Party Senior Manager Clinical Development, Daiichi Sankyo Europe
Study Sponsor  ICMJE Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP