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

Last updated: December 20, 2018
Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Overall Status: Completed

Phase

3

Condition

Metabolic Syndrome

Hypertriglyceridemia

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT00891267
DSE-866/46
2007-003130-41 EudraCT number
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female Europeans at the age of 18 years or above with hypertension, metabolicsyndrome, 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) ofthe following traits of the metabolic syndrome (ATP III criteria):

  • abdominal obesity: waist circumference greater than 102 cm for men and 88 cm forwomen;

  • triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for menand less than 50 mg/dL for women

  • fasting blood glucose greater than or equal to 110mg/dL

Exclusion

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 monthsbefore 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 efficacyor safety of the trial drug(s)

Study Design

Total Participants: 60
Study Start date:
October 01, 2008
Estimated Completion Date:
May 31, 2011

Connect with a study center

  • Erlangen,
    Germany

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.