Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 29, 2009
May 24, 2011
October 2008
April 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00891267 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Hypertension
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2011
April 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00891267
DSE-866/46, 2007-003130-41 EudraCT number
No
Senior Manager Clinical Development, Daiichi Sankyo Europe
Daiichi Sankyo Europe, GmbH
Not Provided
Not Provided
Daiichi Sankyo Inc.
May 2011

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