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Sponsored by: |
Madaus, S.A. |
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Information provided by: | Madaus, S.A. |
ClinicalTrials.gov Identifier: | NCT00502047 |
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.
Condition | Intervention | Phase |
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Hypercholesterolemia Cardiovascular Disease |
Drug: Plantago ovata husk |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 255 |
Study Start Date: | September 2005 |
Study Completion Date: | July 2007 |
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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
History of cardiovascular disease
Spain, Tarragona | |
Hosp. Universitario San Joan de Reus, (Spain) | |
Reus, Tarragona, Spain, 43201 |
Study Chair: | Rosa Solà, MD, phD | Hosp. Universitario San Joan de Reus , Spain |
Principal Investigator: | Manuel Castro, MD, phD | Hosp. Saint Franciscus Gasthuis, Rotterdam (Netherlands) |
Principal Investigator: | Eric Brucker, MD, phD | Hosp. de la Pitié, Paris (France) |
Principal Investigator: | Mª Cruz Almaraz, MD | Hosp. Universitario Carlos Haya, Málaga (Spain) |
Principal Investigator: | Xavier Luque, MD | Centro de Atención Primaria Alcover, Tarragona (Spain) |
Principal Investigator: | José Vicente Vaquer, MD | Centro de Salud Petrer I, Alicante (Spain) |
Principal Investigator: | Luis de Teresa, MD | Hosp. San Vicente de Raspeig, Alicante (Spain) |
Principal Investigator: | Silvia Narejos, MD | Centro de Atención Primaria Centelles, Barcelona (Spain) |
Principal Investigator: | Xavier Farrés, MD | Centro de Atención Primaria El Remei, Vic, Barcelona (Spain) |
Principal Investigator: | José Miguel Martínez, MD | Centro de Salud Tomás Ortuño, Benidorm, Alicante (Spain) |
Study ID Numbers: | PLAN-EC-HIPERL-02, EudraCT number: 2004-002184-24 |
Study First Received: | July 16, 2007 |
Last Updated: | July 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00502047 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
plantago ovata husk soluble fibre hypercholesterolemia cardiovascular risk factor |
Metabolic Diseases Hyperlipidemias Plantain Metabolic Disorder |
Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Hyperlipidemias Cardiovascular Diseases |
Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |