Clinical trial NCT02543099: Efficacy and Safety Study of Policosanol
Official title: The Effect of Policosanol on Elderly Patients With Endothelial Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endothelial Dysfunction
Keywords: endothelial function
policosanol
efficacy
safety
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2015-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: reactive hyperemia index (RHI) measured by Endo-PAT
timeFrame: 6 months after the treatment with policosanol or placebo
Secondary outcomes:
measure: Effects of Policosanol in Older Patients
timeFrame: 6 months after the treatment with policosanol or placebo
measure: 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
timeFrame: 6 months after the treatment with policosanol or placebo
Other outcomes:
Locations:
city: Beijing
country: China
facility: Division of South, General Hospital of Chinese People's Armed Police Forces
state: Beijing
Study officials:
affiliation: Department of geriatric Cardiology, Chinese PLA general hospital
name: ping ye, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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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.
citation: 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.
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.
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. doi: 10.1097/JIM.0000000000000096.
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.