Efficacy and Safety Study of Policosanol

September 3, 2015 updated by: General Hospital of Chinese Armed Police Forces

The Effect of Policosanol on Elderly Patients With Endothelial Dysfunction

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: yuanyuan duan, M.M
  • Phone Number: 86-10-57976873

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Recruiting
        • Division of South, General Hospital of Chinese People's Armed Police Forces
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reactive hyperemia index (RHI) measured by Endo-PAT
Time Frame: 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)
6 months after the treatment with policosanol or placebo

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Policosanol in Older Patients
Time Frame: 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.
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
Time Frame: 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.
6 months after the treatment with policosanol or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Chinese Armed Police Forces

Collaborators

Chinese PLA General Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

August 30, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150811

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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