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OpenTrials
Completed

NCT Number: NCT00891267

Effect of Two Doses of Olmesartan Medoxomil and Amlodipine 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erlangen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Olmesartan medoxomil tablets low dose

Drug

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

Olmesartan medoxomil tablets high dose

Drug

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

Amlodipine

Drug

Amlodipine tablets taken once daily for 6 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Industry

Registry information

Official study title

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

Acronym: VAMOS

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 1, 2009
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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