NCT01562080

Combined Effects of Bioactive Compounds in Lipid Profile

Combined Effects of Bioactive Compounds (ARMOLIPID PLUS ®) on Lipid Profile and Clinical Criteria of Metabolic Syndrome in Patients With Serum Elevated LDL-C

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Rottapharm Spain · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III)

Detailed description

Recently reported that the combination of extract of red yeast rice policosanol composed, berberine, folic acid and coenzyme Q10 (Armolipid Plus ®, Rottapharm) produced a significant improvement in lipid profile in patients with moderately elevated cholesterol levels of low density lipoprotein (LDL-C) plasma. Taking into account the potential effect of Armolipid Plus ® on the lipid profile, it is important to investigate the effectiveness in the field of cardiovascular prevention to define its position in prevention programs.

Conditions

• Hyperlipidemia
• Low-density-lipoprotein-type
• Elevated Triglycerides

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Armolipid Plus	one tablet per day during 12 weeks
DIETARY_SUPPLEMENT	placebo	one tablet per day during 12 weeks

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-06-01
• Completion: 2012-10-01
• First posted: 2012-03-23
• Last updated: 2013-02-28

Locations

1 site across 1 country: Spain