High CholesterolNCT00510809
Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy
A study testing Policosanol and Policosanol Plus Already In Use Statin Therapy in people with High Cholesterol, run by James Backes, PharmD at 1 site in United States.
Trial summary
To determine the effects of policosanol on the cholesterol profile. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- High Cholesterol
- What is being tested?
- Policosanol and Policosanol Plus Already In Use Statin Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LDL > 100
- Male or Non-Pregnant Female. Women must be surgically sterile or postmenopausal and not using hormone replacement therapy (HRT) or using a stable, consistent HRT dose with intentions to continue therapy throughout the course of the study
- Mentally competent to understand study rationale and protocol
- Speak and read English
- Currently receiving low to moderate dose statin therapy with plans to continue to the same dose for at least 8 weeks. Low to moderate dose statins include the following daily doses: atorvastatin ≤20 mg, fluvastatin ≤40 mg, lovastatin ≤40 mg, pravastatin ≤40 mg, rosuvastatin ≤10 mg, simvastatin ≤ 40 mg
Who cannot join
- LDL < 100
- Sensitivity to policosanol
- Currently taking a high-dose statin or other lipid-lowering agents (i.e. high-dose niacin formulations [>500mg/day], bile-acid sequestrants, ezetimibe, fibrates and high-dose Omega-3 fish oils [>900mg of combined EPA/DHA daily])
- Currently taking medications which have the potential to interact with policosanol (i.e. warfarin, high-dose aspirin)
- Active liver disease or ALT level 2.5 times the upper limit of normal
- Chronic disease involving hepatic, renal or coronary artery disease
Show all 16Show fewer
- Currently experiencing "flu-like" symptoms
- Currently experiencing any form of acute physical injury
- Acute psychiatric disorders
- Immuno-compromised state
- Currently taking systemic steroidal drugs
- Currently pregnant or lactating
- Females of childbearing potential
- Dependence on alcohol or illicit drugs
- Participation in any other clinical trial within the last 30 days
- Displays s/s of acute systemic infection (oral temperature >100°F, WBC>12x10³/µL)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study
To determine the effects of policosanol on the cholesterol profile.
Read the detailed description
The primary objectives of this study are to determine the changes in the lipid profile [LDL-C, HDL-C, triglycerides, total cholesterol] and the emerging risk factor, Lp(a), when policosanol is added to statin therapy. Additionally, one more primary objective is to evaluate the safety of the combination regimen.
- Conditions
- High Cholesterol
- Being tested
- Policosanol, Placebo, Policosanol Plus Already In Use Statin Therapy
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolicosanolDrug
Also called Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol
Policosanol 20 mg daily
PlaceboOther
Placebo daily
Policosanol Plus Already In Use Statin TherapyDrug
Also called Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol, Statin
Policosanol 20 mg daily Statin Therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Policosanol 20mg daily Receives: Drug: Policosanol |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
| 3 | Active comparator | Policosanol 20mg daily Plus Statin Therapy Already In Use Receives: Drug: Policosanol Plus Already In Use Statin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Profile
Measured: Change between Week 8 and Baseline
Secondary outcomes (1)
Adverse Events Reported
All events reported that were deemed to be related, or unrelated, to the study drug.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High CholesterolStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Backes, PharmD
- Sponsor type
- University, hospital or other
- Collaborators
- Marcor Development Corporation
- Responsible party
- Sponsor-investigator, James Backes, PharmD, University of Kansas Medical Center
- Investigators
- James M. Backes, PharmD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510809
- Sponsor's protocol ID
- QB840230
- Other IDs
- 10494
- Status last verified
- Sep 2015
- First submitted
- 1 Aug 2007
- Last updated
- 8 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT00510809
- Acronym / sponsor ID
- QB840230
- Conditions
- High Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- James Backes, PharmDUniversity, hospital or other
- Collaborators
- Marcor Development Corporation
- Study start
- Jul 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Posted 20 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effects of policosanol on the cholesterol profile.
Detailed description
The primary objectives of this study are to determine the changes in the lipid profile [LDL-C, HDL-C, triglycerides, total cholesterol] and the emerging risk factor, Lp(a), when policosanol is added to statin therapy. Additionally, one more primary objective is to evaluate the safety of the combination regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PolicosanolPolicosanol 20mg daily |
| 2 | Placebo comparator | Other: Placebo |
| 3 | Active comparator | Drug: Policosanol Plus Already In Use Statin TherapyPolicosanol 20mg daily Plus Statin Therapy Already In Use |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- LDL > 100
- Male or Non-Pregnant Female. Women must be surgically sterile or postmenopausal and not using hormone replacement therapy (HRT) or using a stable, consistent HRT dose with intentions to continue therapy throughout the course of the study
- Mentally competent to understand study rationale and protocol
- Speak and read English
- Currently receiving low to moderate dose statin therapy with plans to continue to the same dose for at least 8 weeks. Low to moderate dose statins include the following daily doses: atorvastatin ≤20 mg, fluvastatin ≤40 mg, lovastatin ≤40 mg, pravastatin ≤40 mg, rosuvastatin ≤10 mg, simvastatin ≤ 40 mg
Key exclusion criteria (16 listed)
- LDL < 100
- Sensitivity to policosanol
- Currently taking a high-dose statin or other lipid-lowering agents (i.e. high-dose niacin formulations [>500mg/day], bile-acid sequestrants, ezetimibe, fibrates and high-dose Omega-3 fish oils [>900mg of combined EPA/DHA daily])
- Currently taking medications which have the potential to interact with policosanol (i.e. warfarin, high-dose aspirin)
- Active liver disease or ALT level 2.5 times the upper limit of normal
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: Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl AlcoholPolicosanol 20 mg daily | Drug | 1 |
| PlaceboPlacebo daily | Other | 2 |
| Policosanol Plus Already In Use Statin TherapyAlso: Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol, StatinPolicosanol 20 mg daily Statin Therapy | Drug | 3 |
Primary outcome
Lipid Profile
Time frame: Change between Week 8 and Baseline
1 secondary outcome
Adverse Events Reported
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James M. Backes, PharmD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Policosanol and Policosanol Plus Already In Use Statin Therapy in people with High Cholesterol, run by James Backes, PharmD at 1 site in United States.
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 5 inclusion and 16 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: finished, as of the sponsor's last update on 8 Oct 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Profile (time frame: Change between Week 8 and Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2015.