Efficacy and Safety Study of Policosanol

Sponsor

General Hospital of Chinese Armed Police Forces (Other)

Overall Status

Unknown status

CT.gov ID

NCT02543099

Collaborator

Chinese PLA General Hospital (Other)

100

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endothelial Dysfunction	Drug: policosanol Drug: placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effect of Policosanol on Elderly Patients With Endothelial Dysfunction

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: policosanol Patients will receive policosanol 20mg daily until the end of the trial.	Drug: policosanol Patients will receive policosanol 20mg Qd Other Names: PPG Lipex dupla ateromixol
Placebo Comparator: placebo Patients will receive placebo 20mg daily until the end of the trial;	Drug: placebo Patients will receive placebo 20mg Qd;

Arm

Intervention/Treatment

Experimental: policosanol

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

Drug: policosanol

Patients will receive policosanol 20mg Qd

Other Names:

PPG

Lipex

dupla

ateromixol

Placebo Comparator: placebo

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

Drug: placebo

Patients will receive placebo 20mg Qd;

Outcome Measures

Primary Outcome Measures

reactive hyperemia index (RHI) measured by Endo-PAT [6 months after the treatment with policosanol or placebo]
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)

Secondary Outcome Measures

Effects of Policosanol in Older Patients [6 months after the treatment with policosanol or placebo]
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.
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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of South, General Hospital of Chinese People's Armed Police Forces	Beijing	Beijing	China	100039

Sponsors and Collaborators

General Hospital of Chinese Armed Police Forces
Chinese PLA General Hospital

Investigators

Principal Investigator: ping ye, M.D, Department of geriatric Cardiology, Chinese PLA general hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

General Hospital of Chinese Armed Police Forces

ClinicalTrials.gov Identifier:

NCT02543099

Other Study ID Numbers:

20150811

First Posted:

Sep 7, 2015

Last Update Posted:

Sep 7, 2015

Last Verified:

Aug 1, 2015

Keywords provided by General Hospital of Chinese Armed Police Forces

Additional relevant MeSH terms:

Policosanol

Study Results

No Results Posted as of Sep 7, 2015