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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01566188 |
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Date of registration:
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08/12/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vascular Impact of Omega-3 in Metabolic Syndrome
CARDIOMEGA |
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Scientific title:
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Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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95 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01566188 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Robinson Joannides, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rouen University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female and male patients with treated essential hypertension (blood pressure
values<140/90 mmHg under antihypertensive treatment).
- Presence of at least two of the following criteria of the metabolic syndrome:
abdominal girth >102 cm in men or >88 cm in women, HDL-C<0.4 g/L in men or <0.5 g/L
in women, fasting triglyceride >1.5 g/L (or specific treatment for these lipid
abnormalities), fasting glucose >1.10 g/L.
Exclusion Criteria:
- Secondary hypertension, myocardial infarction, coronary artery disease,
cerebrovascular disease, stroke or transient ischemia, cardiac failure, diabetes (or
fasting glucose>1.26 g/L) or renal failure (MDRD < 50 ml/min)
- Severe hypercholesterolemia (total cholesterol > 2.5 g/l), alcohol or drug abuse,
toxicomania, or clinically significant abnormalities in other current biological
parameters.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Essential Hypertension
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Metabolic Syndrome
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Intervention(s)
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Dietary Supplement: omega-3 from vegetal origin
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Brachial artery flow-mediated dilatation
[Time Frame: 6 months after omega-3 supplementation]
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Secondary Outcome(s)
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Aortic stiffness
[Time Frame: 6 months after omega-3 supplementation]
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Secondary ID(s)
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2010/010 HP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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