Efficacy and Safety Study of Policosanol
The Effect of Policosanol on Elderly Patients With Endothelial Dysfunction
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to assess the clinical efficacy and safety of policosanol on elderly patients with endothelial dysfunction
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 30, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedSeptember 7, 2015
August 1, 2015
10 months
August 30, 2015
September 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reactive hyperemia index (RHI) measured by Endo-PAT
Novel digital pulse amplitude tonometry (PAT) offers the possibility of an easy and rapid assessment of vascular function. Endothelial function was assessed using a Endo-PAT device (Itamar Medical Ltd, Caesarea, Israel)and recorded as a reactive hyperemia index (RHI)
6 months after the treatment with policosanol or placebo
Secondary Outcomes (2)
Effects of Policosanol in Older Patients
6 months after the treatment with policosanol or placebo
the safety of policosanol evaluated by clinical and statistical analysis, including clinical adverse reactions, laboratory indexes (such as liver function, kidney function and creatine kinase (CK) value) and vital signs
6 months after the treatment with policosanol or placebo
Study Arms (2)
policosanol
EXPERIMENTALPatients will receive policosanol 20mg daily until the end of the trial.
placebo
PLACEBO COMPARATORPatients will receive placebo 20mg daily until the end of the trial;
Interventions
Patients will receive policosanol 20mg Qd
Eligibility Criteria
You may qualify if:
- Age over 60 years old；
- Patients with endothelial dysfunction
- Provision of informed consent prior to any study specific procedures.
You may not qualify if:
- Acute myocardial infarction ,severe trauma , major operation or stroke within six months;
- Tumor or inflammatory diseases
- Known allergies to policosanol
- Life expectancy less than 1 year
- secondary dyslipidemia 6.taking other experimental medicine within six months;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of South, General Hospital of Chinese People's Armed Police Forces
Beijing, Beijing Municipality, 100039, China
Related Publications (7)
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.
PMID: 20550469RESULTAffuso 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.
PMID: 19699071RESULTFaizi 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.
PMID: 19552735RESULTNoa 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.
PMID: 17887938RESULTMoerland 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.
PMID: 22500237RESULTVizzardi 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.
PMID: 24945081RESULTOnkelinx 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.
PMID: 22402933RESULT
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
ping ye, M.D
Department of geriatric Cardiology, Chinese PLA general hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2015
First Posted
September 7, 2015
Study Start
June 1, 2015
Primary Completion
April 1, 2016
Study Completion
June 1, 2016
Last Updated
September 7, 2015
Record last verified: 2015-08