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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Europe, GmbH; Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
• Treatments: Amlodipine; Olmesartan; Olmesartan Medoxomil

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)