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

NCT ID: NCT00891267

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-05-31

Brief Summary

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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

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Conditions

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Metabolic Syndrome Hypertension

Keywords

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Inflammatory markers Vascular protection OM Effect Metabolic syndrome Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Olmesartan medoxomil low dose

Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks

Group Type EXPERIMENTAL

Olmesartan medoxomil tablets low dose

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Olmesartan medoxomil tablets high dose

Intervention Type DRUG

Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks

Amlodipine

Amlodipine taken once daily for 6 weeks

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

Amlodipine tablets taken once daily for 6 weeks

Interventions

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Olmesartan medoxomil tablets low dose

Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks

Intervention Type DRUG

Olmesartan medoxomil tablets high dose

Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks

Intervention Type DRUG

Amlodipine

Amlodipine tablets taken once daily for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Daiichi Sankyo Europe

Locations

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Erlangen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2007-003130-41 EudraCT number

Identifier Type: -

Identifier Source: secondary_id

DSE-866/46

Identifier Type: -

Identifier Source: org_study_id