Efficacy and Safety Study of Policosanol

NCT ID: NCT02543099

Last Updated: 2015-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-06-30

Brief Summary

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The purpose of this study is to assess the clinical efficacy and safety of policosanol on elderly patients with endothelial dysfunction

Detailed Description

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100 selected elderly patients with endothelial dysfunction were randomized to two groups,Group1:received policosanol 20mg qd;Group2:received placebo 20mg qd;endothelial function was tested by peripheral arterial tonometry(PAT) before and after 6 months' treatment with policosanol or placebo respectively; Endothelial dysfunction is defined as reactive hyperemia index(RHI)\< 1.67; The aim of this study is to assess the clinical efficacy and safety of policosanol on elderly patients with endothelial dysfunction.

Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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policosanol

Patients will receive policosanol 20mg daily until the end of the trial.

Group Type EXPERIMENTAL

policosanol

Intervention Type DRUG

Patients will receive policosanol 20mg Qd

placebo

Patients will receive placebo 20mg daily until the end of the trial;

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Patients will receive placebo 20mg Qd;

Interventions

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policosanol

Patients will receive policosanol 20mg Qd

Intervention Type DRUG

placebo

Patients will receive placebo 20mg Qd;

Intervention Type DRUG

Other Intervention Names

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PPG Lipex dupla ateromixol

Eligibility Criteria

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Inclusion Criteria

1. Age over 60 years old;
2. Patients with endothelial dysfunction
3. Provision of informed consent prior to any study specific procedures.

Exclusion Criteria

1. Acute myocardial infarction ,severe trauma , major operation or stroke within six months;
2. Tumor or inflammatory diseases
3. Known allergies to policosanol
4. Life expectancy less than 1 year
5. secondary dyslipidemia 6.taking other experimental medicine within six months;
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

General Hospital of Chinese Armed Police Forces

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ping ye, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of geriatric Cardiology, Chinese PLA general hospital

Locations

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Division of South, General Hospital of Chinese People's Armed Police Forces

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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ping ye, M.D

Role: CONTACT

86-10-57976872

yuanyuan duan, M.M

Role: CONTACT

86-10-57976873

Facility Contacts

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yuanyuan duan, M.M..

Role: primary

86-10-57976873

References

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Reriani MK, Lerman LO, Lerman A. Endothelial function as a functional expression of cardiovascular risk factors. Biomark Med. 2010 Jun;4(3):351-60. doi: 10.2217/bmm.10.61.

Reference Type RESULT
PMID: 20550469 (View on PubMed)

Affuso F, Ruvolo A, Micillo F, Sacca L, Fazio S. Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 2010 Nov;20(9):656-61. doi: 10.1016/j.numecd.2009.05.017. Epub 2009 Aug 20.

Reference Type RESULT
PMID: 19699071 (View on PubMed)

Faizi AK, Kornmo DW, Agewall S. Evaluation of endothelial function using finger plethysmography. Clin Physiol Funct Imaging. 2009 Sep;29(5):372-5. doi: 10.1111/j.1475-097X.2009.00882.x. Epub 2009 Jun 22.

Reference Type RESULT
PMID: 19552735 (View on PubMed)

Noa M, Mas R, Lariot C. Protective effect of policosanol on endothelium and intimal thickness induced by forceps in rabbits. J Med Food. 2007 Sep;10(3):452-9. doi: 10.1089/jmf.2006.232.

Reference Type RESULT
PMID: 17887938 (View on PubMed)

Moerland M, Kales AJ, Schrier L, van Dongen MG, Bradnock D, Burggraaf J. Evaluation of the EndoPAT as a Tool to Assess Endothelial Function. Int J Vasc Med. 2012;2012:904141. doi: 10.1155/2012/904141. Epub 2012 Feb 14.

Reference Type RESULT
PMID: 22500237 (View on PubMed)

Vizzardi E, Gavazzoni M, Della Pina P, Bonadei I, Regazzoni V, Sciatti E, Trichaki E, Raddino R, Metra M. Noninvasive assessment of endothelial function: the classic methods and the new peripheral arterial tonometry. J Investig Med. 2014 Aug;62(6):856-64. doi: 10.1097/JIM.0000000000000096.

Reference Type RESULT
PMID: 24945081 (View on PubMed)

Onkelinx S, Cornelissen V, Goetschalckx K, Thomaes T, Verhamme P, Vanhees L. Reproducibility of different methods to measure the endothelial function. Vasc Med. 2012 Apr;17(2):79-84. doi: 10.1177/1358863X12436708. Epub 2012 Mar 8.

Reference Type RESULT
PMID: 22402933 (View on PubMed)

Other Identifiers

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20150811

Identifier Type: -

Identifier Source: org_study_id

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