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Trial NCT00891267

Resource URI: http://static.linkedct.org/resource/trials/NCT00891267
linkedct:acronym VAMOS
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/33461>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/55057>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/55058>
linkedct:brief_title Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
linkedct:condition <http://static.linkedct.org/resource/condition/6238>
linkedct:condition <http://static.linkedct.org/resource/condition/7999>
linkedct: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)
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date July 2009
linkedct:enrollment 60 (xsd:int)
linkedct:firstreceived_date April 29, 2009
linkedct:has_dmc No
linkedct:id NCT00891267
linkedct:intervention <http://static.linkedct.org/resource/intervention/100398>
linkedct:intervention <http://static.linkedct.org/resource/intervention/100399>
linkedct:intervention <http://static.linkedct.org/resource/intervention/67090>
rdfs:label Trial NCT00891267
linkedct:lastchanged_date April 30, 2009
linkedct:lead_sponsor_agency Daiichi Sankyo Europe, GmbH
linkedct:location <http://static.linkedct.org/resource/location/50647>
linkedct:nct_id NCT00891267
linkedct:number_of_arms 3 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
linkedct:org_study_id DSE-866/46
linkedct:overall_contact_email roland.schmieder@uk-erlangen.de
linkedct:overall_contact_last_name Roland E. Schmieder, Prof.
linkedct:overall_contact_phone +49 (0)9131 85 36245
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1106>
foaf:page <http://clinicaltrials.gov/show/NCT00891267>
linkedct:phase Phase 3
linkedct:primary_completion_date June 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/48931>
linkedct:secondary_id 2007-003130-41 EudraCT number
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/124461>
linkedct:source Daiichi Sankyo Inc.
linkedct:start_date October 2008
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date April 2009