Viewing Study NCT00502047



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Last Modification Date: 2024-10-26 @ 9:34 AM
Study NCT ID: NCT00502047
Status: COMPLETED
Last Update Posted: 2007-07-17
First Post: 2007-07-16

Brief Title: Effect of the Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia
Sponsor: Rottapharm Spain
Organization: Rottapharm Spain

Study Overview

Official Title: Multicentre Comparative Double-Blind Two-Arm Parallel Clinical Trial of the Effects of Treatment With Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia
Status: COMPLETED
Status Verified Date: 2007-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The hypothesis of this study is that soluble fibre may contribute to a reduction of the low density lipoprotein cholesterol LDL-c and the combined effect with a statin may achieve an optimisation of the cholesterol-lowering effects in adults with several cardiovascular risk factors
Detailed Description: It has been demonstrated that high concentrations of cholesterol and low density lipoprotein cholesterol LDL high risk cholesterol are the major risk factors for heart disease myocardial infarction and angina pectoris Moreover these conditions represent the major cause of death in the Western world

Of the measures established to reduce blood cholesterol levels the introduction of consumption of dietary fibre is a novelty The term dietary fibre defines a variety of substances that are found in plants and are resistant to digestion by human gastrointestinal enzymes

The studies performed up until now to determine the effects of fibre on blood lipids have demonstrated that consumption of soluble fibre can reduce cholesterol

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
EudraCT number 2004-002184-24 None None None