Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients with Metabolic Syndrome - VAMOS

• Conditions: Metabolic SyndromeHypertension; MedDRA version: 9.1Level: LLTClassification code 10052066Term: Metabolic syndrome; MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2007-003130-41-DE
• Lead Sponsor: DAIICHI-SANKYO EUROPE GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-29
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation.
At baseline, patients must have:
• Blood pressure = 130/85 mmHg or drug treatment for hypertension, AND
• hs-CRP = 1.0 and < 10.0 mg/dL,
AND at least two (2) of the following traits of the metabolic syndrome (AHA/NHLBI (2005) updated ATP III criteria):
• abdominal obesity: waist circumference > 102 cm for men and > 88 cm for women;
• triglyceride level = 150 mg/dL or drug treatment for elevated TG;
• HDL < 40 mg/dL for men and < 50 mg/dL for women or drug treatment for reduced HDL;
• fasting blood glucose = 100mg/dL or drug treatment for elevated glucose.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Insulin depended diabetes or type-1 diabetes;
• Severe or resistant hypertension;
• Patients with secondary hypertension of any aetiology, such as renal disease, pheocromocytoma, 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), including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic (criteria for metabolic syndrome see above), hematological or oncological, neurological and psychiatric diseases;
• Patients having a history of the following within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, stroke or transient ischemic attack;
• Patients with clinically significant abnormal laboratory values at screening and baseline;
• Patients with contraindication to olmesartan medoxomil or amlodipine besilate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified