Efficacy and Safety Study of Policosanol

The Effect of Policosanol on Elderly Patients With Endothelial Dysfunction

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02543099

Enrollment

100

Registered

2015-09-07

Start date

2015-06-30

Completion date

2016-06-30

Last updated

2015-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction

Keywords

endothelial function, policosanol, efficacy, safety

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.

Interventions

DRUGpolicosanol

Patients will receive policosanol 20mg Qd

DRUGplacebo

Patients will receive placebo 20mg Qd;

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary Contactping ye, M.D

dodyy0601@163.com86-10-57976872

Backup Contactyuanyuan duan, M.M

86-10-57976873

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026