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Combined Effects of Bioactive Compounds in Lipid Profile (ARM-PLUS-LDL)

This study has been completed.
Sponsor:
Collaborator:
Centro Tecnológico de Nutrición y Salud
Information provided by (Responsible Party):
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT01562080
First received: March 21, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes

March 21, 2012
February 27, 2013
January 2012
June 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01562080 on ClinicalTrials.gov Archive Site
  • Cardiovascular risk (according to the Framingham tables). [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
  • Criteria for Metabolic Syndrome [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
  • Levels of triglycerides and cholesterol high density lipoprotein (HDL-C). [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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)

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hyperlipidemia
  • Low-density-lipoprotein-type
  • Elevated Triglycerides
  • Dietary Supplement: Armolipid Plus
    one tablet per day during 12 weeks
    Other Name: Armolipid Plus
  • Dietary Supplement: placebo
    one tablet per day during 12 weeks
  • Experimental: Dietary supplement
    red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid
    Intervention: Dietary Supplement: Armolipid Plus
  • Placebo Comparator: microcrystalline cellulose
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
October 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01562080
ARM-PLUS-LDL
No
Rottapharm Spain
Rottapharm Spain
Centro Tecnológico de Nutrición y Salud
Study Director: Rosa Solà, MD PhD Hosp. Universitari Sant Joan de Reus (Tarragona)
Principal Investigator: Jesús Millán, MD PhD Hosp. Universitario Gregorio Marañón (Madrid)
Principal Investigator: José R Calabuig, MD PhD Hosp. Universitario La Fe (Valencia)
Principal Investigator: José Villar, MD PhD Hosp. Universitario Virgen del Rocío (Sevilla)
Principal Investigator: José Puzo, MD PhD Hosp. Universitario San Jorge (Huesca)
Principal Investigator: Angel Brea, MD Hosp. Universitario San Pedro ( Logroño)
Rottapharm Spain
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP