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

Phase 3

Completed

• Conditions: Metabolic Syndrome; Hypertension
• Interventions: Drug: Olmesartan medoxomil tablets low dose; Drug: Olmesartan medoxomil tablets high dose; Drug: Amlodipine

• Registration Number: NCT00891267
• Lead Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-04-29
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2011-04
• Status Verified: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Olmesartan medoxomil low dose	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	Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
Amlodipine	Amlodipine	Amlodipine taken once daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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