Combined Effects of Bioactive Compounds in Lipid Profile

Hyperlipidemia Clinical Trial

— ARM-PLUS-LDL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562080
• Other study ID #: ARM-PLUS-LDL
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 21, 2012
• Last updated: February 27, 2013
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Rottapharm Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients > 18 years old

• LDL-c plasma levels =130 mg/dL and = 189 mg/dL

• Patients not requiring lipid-lowering drug treatment according to ATPIII guidelines,that do not have cardiovascular disease, stroke or intermittent claudication, diabetes mellitus, renal or Patients who have demonstrated effects or contraindications to lipid-lowering drug therapy (in this case, treatment should be discontinued 1 month before baseline.

• Signed and dated informed consent before any study specific procedure.

Exclusion Criteria:

• Patients on drug therapy to reduce LDL-C, for example, statins, bile acid sequestrants, nicotinic acid, fibrates or similar (up to 1 month before baseline).

• History of cardiovascular disease, stroke or intermittent claudication.

• Diabetes mellitus (at least 2 blood fasting glucose greater than 126 mg / dL).

• Having taken any functional food with sterols, stanols or similar or any nutraceutical with lipid-lowering effects during the previous 7 days.

• Plasma levels of triglycerides > 350 mg/dl

• Diagnosis of familial hypercholesterolemia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Armolipid Plus
one tablet per day during 12 weeks
• placebo
one tablet per day during 12 weeks

Locations

Country	Name	City	State
Spain	Hosp. Universitario San Joan	Reus	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
Rottapharm Spain	Centro Tecnológico de Nutrición y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	investigate whether the addition of Armolipid Plus ® decreases by 20% LDL-C levels compared to baseline in patients with initial levels of LDL-C = 130 mg / dL.		twelve weeks	No
Secondary	Cardiovascular risk (according to the Framingham tables).		twelve weeks	No
Secondary	Criteria for Metabolic Syndrome		twelve weeks	No
Secondary	Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).		twelve weeks	No