Efficacy and Safety Study of Policosanol

Endothelial Dysfunction Clinical Trial

Official title:

The Effect of Policosanol on Elderly Patients With Endothelial Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02543099
• Other study ID #: 20150811
• Status: Recruiting
• Phase: Phase 3
• First received: August 30, 2015
• Last updated: September 3, 2015
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: General Hospital of Chinese Armed Police Forces
• Contact: ping ye, M.D
• Phone: 86-10-57976872
• Email: dodyy0601[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Drug:
• policosanol
Patients will receive policosanol 20mg Qd
• placebo
Patients will receive placebo 20mg Qd;

Locations

Country	Name	City	State
China	Division of South, General Hospital of Chinese People's Armed Police Forces	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Affuso F, Ruvolo A, Micillo F, Saccà 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. 20 — View Citation

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. — View Citation

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. — View Citation

Noa M, Más 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Effects of Policosanol in Older Patients	Triglyceride(TG),total cholesterol (TC), low-density lipoprotein(LDL-C), high- density lipoprotein cholesterol (HDL-C ), lipoprotein (a), apolipoprotein AI (apo AI) and apolipoprotein B (apo B) were measured at the clinical biochemistry.	6 months after the treatment with policosanol or placebo	Yes
Secondary	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	The safety was 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	Yes