Effect of the Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rottapharm Spain

Criteria

Inclusion Criteria:

• Levels of LDL-c between >130 mg/dl and <189 mg/dl

• Presence at least 1 of the cardiovascular risk factor defined as:

• age above 45 years in men and 55 years in women

• smoker

• high blood pressure

• HDL-c < 40 mg/dl in men and <46 mg/dl in women

• family background of early heart disease

• Patients who have given informed consent

• Patients who will be capable of following diet guidelines

Exclusion Criteria:

• Triglycerides >350 mg/dl

• History of cardiovascular disease

• treatment with statins prior to the beginning of the trial and who have not dropped out at least 2 months before the beginning of the study

• Diabetes mellitus