Endothelial DysfunctionPhase 3NCT02543099
Efficacy and Safety Study of Policosanol
A Phase 3 study testing policosanol in people with Endothelial Dysfunction, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
Trial summary
The purpose of this study is to assess the clinical efficacy and safety of policosanol on elderly patients with endothelial dysfunction Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- policosanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 60 years old；
- Patients with endothelial dysfunction
- Provision of informed consent prior to any study specific procedures.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
yuanyuan duan, M.M contact
China1 site, 1 recruiting
- Recruiting
Division of South, General Hospital of Chinese People's Armed Police Forces
Beijing, Beijing Municipality, 100039
yuanyuan duan, M.M.., 86-10-57976873, dodyy0601@163.com
About this study
Official title: 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
Read the 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.
- Conditions
- Endothelial Dysfunction
- Being tested
- policosanol, placebo
- Keywords
- endothelial function, policosanol, efficacy, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
policosanolDrug
Also called PPG, Lipex, dupla, ateromixol
Patients will receive policosanol 20mg Qd
placeboDrug
Patients will receive placebo 20mg Qd;
| Study group | Role | What they receive |
|---|---|---|
| policosanol | Experimental | Patients will receive policosanol 20mg daily until the end of the trial. Receives: Drug: policosanol |
| placebo | Placebo comparator | Patients will receive placebo 20mg daily until the end of the trial; Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
reactive hyperemia index (RHI) measured by Endo-PAT
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)
Measured: 6 months after the treatment with policosanol or placebo
Secondary outcomes (2)
Effects of Policosanol in Older Patients
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.
Measured: 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
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.
Measured: 6 months after the treatment with policosanol or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Chinese Armed Police Forces
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- ping ye, M.D, Principal investigator, Department of geriatric Cardiology, Chinese PLA general hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543099
- Sponsor's protocol ID
- 20150811
- Status last verified
- Aug 2015
- First submitted
- 30 Aug 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reriani MK, Lerman LO, Lerman A. Endothelial function as a functional expression of cardiovascular risk factors. Biomark Med. 2010 Jun;4(3):351-60. doi: 10.2217/bmm.10.61.
PubMed 20550469Affuso F, Ruvolo A, Micillo F, Sacca L, Fazio S. Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 2010 Nov;20(9):656-61. doi: 10.1016/j.numecd.2009.05.017. Epub 2009 Aug 20.
PubMed 19699071Faizi 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.
PubMed 19552735Noa 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.
PubMed 17887938Moerland 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.
PubMed 22500237Vizzardi 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.
PubMed 24945081Onkelinx 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.
PubMed 22402933
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Policosanol on Elderly Patients With Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT02543099
- Acronym / sponsor ID
- 20150811
- Conditions
- Endothelial Dysfunction
- Keywords
- endothelial function, policosanol, efficacy, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| policosanol | Experimental | Drug: policosanolPatients will receive policosanol 20mg daily until the end of the trial. |
| placebo | Placebo comparator | Drug: placeboPatients will receive placebo 20mg daily until the end of the trial; |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 60 years old；
- Patients with endothelial dysfunction
- Provision of informed consent prior to any study specific procedures.
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| policosanolAlso: PPG, Lipex, dupla, ateromixolPatients will receive policosanol 20mg Qd | Drug | policosanol |
| placeboPatients will receive placebo 20mg Qd; | Drug | placebo |
Primary outcome
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)
2 secondary outcomes
Effects of Policosanol in Older Patients
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Results publication: PubMed 20550469Reriani MK, Lerman LO, Lerman A. Endothelial function as a functional expression of cardiovascular risk factors. Biomark Med. 2010 Jun;4(3):351-60. doi: 10.2217/bmm.10.61.
- Results publication: PubMed 19699071Affuso F, Ruvolo A, Micillo F, Sacca L, Fazio S. Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 2010 Nov;20(9):656-61. doi: 10.1016/j.numecd.2009.05.017. Epub 2009 Aug 20.
- Results publication: PubMed 19552735Faizi 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.
- Results publication: PubMed 17887938Noa 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.
- Results publication: PubMed 22500237Moerland 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.
- Results publication: PubMed 24945081Vizzardi 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.
- Results publication: PubMed 22402933Onkelinx 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yuanyuan duan, M.M contact
ping ye, M.D principal investigator
Department of geriatric Cardiology, Chinese PLA general hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing policosanol in people with Endothelial Dysfunction, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ping ye, M.D (86-10-57976872, dodyy0601@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reactive hyperemia index (RHI) measured by Endo-PAT (time frame: 6 months after the treatment with policosanol or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02543099, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.