Effects of Armolipid Plus on Cholesterol Levels and Endot... | NCT00654459

Studies
Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

NCT00654459

Sponsor

Federico II University

Status

Completed

Last Update Posted

Apr 16, 2008Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Hyperlipidemia
Endothelial Dysfunction

Interventions

Mixture of Berberine, Policosanol, Red Yeast, Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Apr 2, 2008

First Submission Date that Met QC Criteria

Apr 7, 2008

First Posted Date

Apr 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2008

Last Update Posted Date

Apr 16, 2008Estimated

Name	Class
Rottapharm	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo
B			Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mixture of Berberine, Policosanol, Red Yeast, Placebo	Dietary Supplement	A tablet one a day for 6 weeks	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test.		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

males and females aged between 18 and 70 with hypercholesterolemya

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Serafino Fazio, MD	Federico II University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of internal medicine University Federico II		Naples		80131	Italy

Type	Date	Date Unknown
Release	Jan 28, 2009
Reset	Feb 24, 2009
Release	Aug 19, 2009
Reset	Sep 24, 2009
Release	May 25, 2010
Reset	Jun 28, 2010
Release	Jun 28, 2010
Reset	Jul 26, 2010
Release	Jun 24, 2011
Reset	Jul 20, 2011

Submission Tracking

Estimated Results First Submitted Date

Jan 28, 2009

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 28, 2009			Feb 24, 2009
Aug 19, 2009

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C080710	policosanol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided