Efficacy and Safety Study of Policosanol

Phase 3

• Conditions: Endothelial Dysfunction
• Interventions: Drug: policosanol; Drug: placebo

• Registration Number: NCT02543099
• Lead Sponsor: General Hospital of Chinese Armed Police Forces

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.

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-08
• Study First Submitted: 2015-08-30
• Study First Submitted QC: 2015-09-03
• Last Update Submitted: 2015-09-03
• Study First Posted: 2015-09-07
• Last Update Posted: 2015-09-07
• Primary Completion: 2016-04
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
policosanol	policosanol	Patients will receive policosanol 20mg daily until the end of the trial.
placebo	placebo	Patients will receive placebo 20mg daily until the end of the trial;

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Division of South, General Hospital of Chinese People's Armed Police Forces; 🇨🇳 Beijing, Beijing, China