HypercholesterolemiaPhase 3NCT00288483
Cholesterol-Lowering Effects of Policosanol
A Phase 3 study testing Policosanol in people with Hypercholesterolemia and Combined Hyperlipidemia, run by Drug Commission of the German Medical Association.
Trial summary
Despite undeniable progress in the reduction of morbidity and mortality of coronary heart disease (CHD) prevention is a mainstay for medical intervention. The importance of elevated serum cholesterol for the formation and progress of CHD can be regarded as proved after the results of the major intervention studies… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia, Combined Hyperlipidemia
- What is being tested?
- Policosanol
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2000to Jul 2001
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated hypercholesterolaemia or combined hyperlipidaemia with mean LDL values at Visits 2 and 3 of > 150 mg/dl for patients with no or one risk factor (other than known coronary artery disease) or 150-189 mg/dl for patients with two or more risk factors for the development of cardiovascular events (males > 45 years of age, females > 55 years of age or postmenopausal), known coronary artery disease, uncontrolled hypertension > 140 mm Hg systolic, HDL level < 35 mg/dl (mean of the values of visits 2 and 3), current cigarette smoking of > 10 cigarettes/day, obesity with BMI > 30 kg/m², family history of coronary heart disease),
- male or female patients aged from 18 to 80 years,
- negative pregnancy test for woman of childbearing potential,
- no communication problems with the investigator,
- availability of a signed informed consent to participate in the trial, for medical data to be recorded and made available to a third party.
Who cannot join
- - known hypersensitivity to any component of the drug,
- myocardial infarction less than one year before clinical trial inclusion,
- PTCA or CABG less than one year before clinical trial inclusion,
- unstable angina pectoris,
- hypothyroidism,
- diabetes mellitus,
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- acute inflammatory diseases,
- severe gastrointestinal diseases,
- triglycerides values > 500 mg/dl at Visit 2 or 3,
- use of oral systemic corticosteroids, anticoagulants or other lipid-lowering drugs,
- serious diseases or circumstances not allowing the patient's participation in the trial (e.g. malignoma, alcoholism or drug abuse, severe kidney and liver diseases),
- pregnancy, lactation and women of childbearing potential without employing a safe contraception method,
- participation in a clinical trial within the last 30 days before Visit 1,
- repeated inclusion in the present clinical trial.
About this study
Official title: Placebo-Controlled, Randomised, Double-Blind, Multi-Centre Clinical Trial on Dose-Dependent Cholesterol-Lowering Effects of Policosanol in Patients With Hypercholesterolaemia With 10 to 80 Mg Policosanol for 12 Weeks
Despite undeniable progress in the reduction of morbidity and mortality of coronary heart disease (CHD) prevention is a mainstay for medical intervention. The importance of elevated serum cholesterol for the formation and progress of CHD can be regarded as proved after the results of the major intervention studies became available. These studies have provided key evidence for a positive correlation of lipid lowering and decreased mortality. Other studies in patients with established CHD have shown that stabilization and regression of atherosclerotic lesions is possible with lowering of cholesterol using a variety of agents. Different studies have also investigated the long-term effects of lipid lowering strategies on atherosclerosis by means of coronary angiography and have demonstrated that lipid reduction reduces progression of atherosclerosis and can promote atherosclerosis regression. Thus, it has been demonstrated that cholesterol lowering therapy reduces the risk of CHD and diminishes cardiovascular morbidity and mortality.
Policosanol is a drug that presumably possesses both hypocholesterolemic and antiplatelet effects. Furthermore there are hints to even more positive effects that influence the development of atherosclerosis, i.e. inhibition of LDL peroxidation and smooth muscle cell proliferation.
Read more
Previous studies showed efficacy in dose ranges of mostly 5 to 20 mg Policosanol per day. As nearly all previous studies have been performed in Latin America it cannot be excluded that either ethnic or nutritional factors contribute to the dose found to be optimal in this region. This circumstance as well as the requirement to meet the ICH Guideline "Ethnic Factors in the Acceptability of Foreign Clinical Data" make further studies, i.e. a dose-finding clinical trial, an efficacy clinical trial in European patients and a long-term tolerability clinical trial in Caucasian patients necessary.
It is known from more than 60 clinical studies performed so far that Policosanol has an excellent safety profile. A placebo-controlled design was considered appropriate as patients with two or more risk factors for the development of cardiovascular events and a LDL of greater than 190 mg/dl were excluded; the chance of getting an active lipid-lowering agent during the treatment phase was 80 %.
Read the detailed description
Visit 1: Informed consent, Inclusion and exclusion criteria, medical history, concomitant diseases and medication, physical examination, vital signs, lipid profile, safety lab, urine analysis, 12-lead EKG. Diet counseling.
Run-in phase six weeks. Visit 2 and 3 (5 and 6 weeks after visit 1): Baseline lipids. Visit 4: Baseline lipid sample, start treatment. Randomization to one of five groups, placebo, 10 mg, 20 mg, 40 mg, or 80 mg policosanol.
Visit 5 and 6 (6 and 12 weeks after visit 4): Lipid sample. Safety lab.
- Conditions
- Hypercholesterolemia, Combined Hyperlipidemia
- Being tested
- Policosanol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolicosanolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in LDL cholesterol
Secondary outcomes (1)
Changes in other lipoproteins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startSep 2000
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
Sponsor and investigators
- Lead sponsor
- Drug Commission of the German Medical Association
- Sponsor type
- University, hospital or other
- Collaborators
- Madaus AG
- Investigators
- Heiner K. Berthold, MD, PhD, Principal investigator, Drug Commission of the German Medical Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288483
- Sponsor's protocol ID
- PC53W0.01
- Status last verified
- Nov 2005
- First submitted
- 6 Feb 2006
- Last updated
- 21 Jul 2006
- Results posted
- No
Publications
Berthold HK, Unverdorben S, Degenhardt R, Bulitta M, Gouni-Berthold I. Effect of policosanol on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia: a randomized controlled trial. JAMA. 2006 May 17;295(19):2262-9. doi: 10.1001/jama.295.19.2262.
PubMed 16705107
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Randomised, Double-Blind, Multi-Centre Clinical Trial on Dose-Dependent Cholesterol-Lowering Effects of Policosanol in Patients With Hypercholesterolaemia With 10 to 80 Mg Policosanol for 12 Weeks
- ClinicalTrials.gov ID
- NCT00288483
- Acronym / sponsor ID
- PC53W0.01
- Conditions
- Hypercholesterolemia, Combined Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Drug Commission of the German Medical AssociationUniversity, hospital or other
- Collaborators
- Madaus AG
- Study start
- Sep 2000
- Study completion
- Jul 2001
- First posted
- 8 Feb 2006 (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.
Despite undeniable progress in the reduction of morbidity and mortality of coronary heart disease (CHD) prevention is a mainstay for medical intervention. The importance of elevated serum cholesterol for the formation and progress of CHD can be regarded as proved after the results of the major intervention studies became available. These studies have provided key evidence for a positive correlation of lipid lowering and decreased mortality. Other studies in patients with established CHD have shown that stabilization and regression of atherosclerotic lesions is possible with lowering of cholesterol using a variety of agents. Different studies have also investigated the long-term effects of lipid lowering strategies on atherosclerosis by means of coronary angiography and have demonstrated that lipid reduction reduces progression of atherosclerosis and can promote atherosclerosis regression. Thus, it has been demonstrated that cholesterol lowering therapy reduces the risk of CHD and diminishes cardiovascular morbidity and mortality.
Policosanol is a drug that presumably possesses both hypocholesterolemic and antiplatelet effects. Furthermore there are hints to even more positive effects that influence the development of atherosclerosis, i.e. inhibition of LDL peroxidation and smooth muscle cell proliferation.
Previous studies showed efficacy in dose ranges of mostly 5 to 20 mg Policosanol per day. As nearly all previous studies have been performed in Latin America it cannot be excluded that either ethnic or nutritional factors contribute to the dose found to be optimal in this region. This circumstance as well as the requirement to meet the ICH Guideline "Ethnic Factors in the Acceptability of Foreign Clinical Data" make further studies, i.e. a dose-finding clinical trial, an efficacy clinical trial in European patients and a long-term tolerability clinical trial in Caucasian patients necessary.
It is known from more than 60 clinical studies performed so far that Policosanol has an excellent safety profile. A placebo-controlled design was considered appropriate as patients with two or more risk factors for the development of cardiovascular events and a LDL of greater than 190 mg/dl were excluded; the chance of getting an active lipid-lowering agent during the treatment phase was 80 %.
Detailed description
Visit 1: Informed consent, Inclusion and exclusion criteria, medical history, concomitant diseases and medication, physical examination, vital signs, lipid profile, safety lab, urine analysis, 12-lead EKG. Diet counseling.
Run-in phase six weeks. Visit 2 and 3 (5 and 6 weeks after visit 1): Baseline lipids. Visit 4: Baseline lipid sample, start treatment. Randomization to one of five groups, placebo, 10 mg, 20 mg, 40 mg, or 80 mg policosanol.
Visit 5 and 6 (6 and 12 weeks after visit 4): Lipid sample. Safety lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Isolated hypercholesterolaemia or combined hyperlipidaemia with mean LDL values at Visits 2 and 3 of > 150 mg/dl for patients with no or one risk factor (other than known coronary artery disease) or 150-189 mg/dl for patients with two or more risk factors for the development of cardiovascular events (males > 45 years of age, females > 55 years of age or postmenopausal), known coronary artery disease, uncontrolled hypertension > 140 mm Hg systolic, HDL level < 35 mg/dl (mean of the values of visits 2 and 3), current cigarette smoking of > 10 cigarettes/day, obesity with BMI > 30 kg/m², family history of coronary heart disease),
- male or female patients aged from 18 to 80 years,
- negative pregnancy test for woman of childbearing potential,
- no communication problems with the investigator,
- availability of a signed informed consent to participate in the trial, for medical data to be recorded and made available to a third party.
Key exclusion criteria (14 listed)
- - known hypersensitivity to any component of the drug,
- myocardial infarction less than one year before clinical trial inclusion,
- PTCA or CABG less than one year before clinical trial inclusion,
- unstable angina pectoris,
- hypothyroidism,
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 |
|---|---|---|
| Policosanol | Drug | – |
Primary outcome
Decrease in LDL cholesterol
1 secondary outcome
Changes in other lipoproteins
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2006.
- Results publication: PubMed 16705107Berthold HK, Unverdorben S, Degenhardt R, Bulitta M, Gouni-Berthold I. Effect of policosanol on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia: a randomized controlled trial. JAMA. 2006 May 17;295(19):2262-9. doi: 10.1001/jama.295.19.2262.
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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.
Heiner K. Berthold, MD, PhD principal investigator
Drug Commission of the German Medical Association
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Policosanol in people with Hypercholesterolemia and Combined Hyperlipidemia, run by Drug Commission of the German Medical Association.
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 14 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: stopped early, as of the sponsor's last update on 21 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was stopped early. Results are not available in the source record.
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?
Decrease in LDL cholesterol. 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 NCT00288483, which also lists 1 linked publication.
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 21 Jul 2006.