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

Hypertension Clinical Trial

— VAMOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891267
• Other study ID #: DSE-866/46
• Secondary ID: 2007-003130-41 E
• Status: Completed
• Phase: Phase 3
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Olmesartan medoxomil tablets low dose
Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
• Olmesartan medoxomil tablets high dose
Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
• Amlodipine
Amlodipine tablets taken once daily for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 weeks for each treatment
Secondary	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)		6 weeks for each treatment