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Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00654459
First Posted: April 8, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rottapharm
Information provided by:
Federico II University
  Purpose

Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy.

The aim of this study was to evaluate the lipid lowering effects and the improvement of endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product (Armolipid Plus)


Condition Intervention Phase
Hyperlipidemia Endothelial Dysfunction Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • The primary outcome measure of this study was the percentage change from baseline of total cholesterol (C), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C),and Triglycerides (Tg) plasma concentrations. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test. [ Time Frame: 6 weeks ]

Enrollment: 50
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo
A tablet one a day for 6 weeks
Other Name: Armolipid Plus
B Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo
A tablet one a day for 6 weeks
Other Name: Armolipid Plus

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
males and females aged between 18 and 70 with hypercholesterolemya
Criteria

Inclusion Criteria:

  • Males and females aged between 18 and 70
  • Total cholesterol levels > 220 mg/dl and LDL-Cholesterol > 130 mg/dl;
  • Patients with concomitant pathology such as diabetes, chronic heart failure, coronary artery disease, arterial hypertension, dysthyroidism, were admitted as long as stable in the previous three months

Exclusion Criteria:

  • Proven intolerance to an Armolipid Plus compound
  • Pregnant women, and women planning to conceive
  • Patients in therapy with lipid lowering drugs within the previous 6 weeks
  • Triglycerides concentration > 500mg/dl were excluded.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654459


Locations
Italy
Department of internal medicine University Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Rottapharm
Investigators
Principal Investigator: Serafino Fazio, MD Federico II University
  More Information

Responsible Party: Serafino Fazio MD, Federico II University
ClinicalTrials.gov Identifier: NCT00654459     History of Changes
Other Study ID Numbers: ARM 02-07
First Submitted: April 2, 2008
First Posted: April 8, 2008
Last Update Posted: October 12, 2017
Last Verified: April 2008

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Policosanol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Platelet Aggregation Inhibitors