Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

This study has been completed.
Sponsor:
Collaborator:
Rottapharm
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00654459
First received: April 2, 2008
Last updated: April 14, 2008
Last verified: April 2008
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Serafino Fazio MD, Federico II University
ClinicalTrials.gov Identifier: NCT00654459     History of Changes
Other Study ID Numbers: ARM 02-07
Study First Received: April 2, 2008
Last Updated: April 14, 2008
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on August 01, 2014