- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00288483
Cholesterol-Lowering Effects of Policosanol
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.
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 %.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- - 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,
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Decrease in LDL cholesterol
|
Secondary Outcome Measures
Outcome Measure |
---|
Changes in other lipoproteins
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Heiner K. Berthold, MD, PhD, Drug Commission of the German Medical Association
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PC53W0.01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypercholesterolemia
-
National Medical Research Center for Therapy and...Moscow State University of Medicine and DentistryRecruitingMedication Adherence | Adherence, Medication | Treatment Adherence | Familial Hypercholesterolemia | Motivational Interviewing | Adherence, Patient | Treatment Adherence and Compliance | Patient Compliance | Adherence | Hypercholesterolemia, Familial | Patient Adherence | Hypercholesterolemia, Autosomal Dominant and other conditionsRussian Federation
-
Direct PlantesUnknownHYPERCHOLESTEROLEMIAFrance
-
Chong Kun Dang PharmaceuticalRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Addpharma Inc.CompletedPrimary HypercholesterolemiaKorea, Republic of
-
JW PharmaceuticalCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Provident Clinical ResearchGlaxoSmithKlineUnknownPrimary HypercholesterolemiaUnited States
-
Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
-
Boryung Pharmaceutical Co., LtdRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Ahn-Gook Pharmaceuticals Co.,LtdRecruitingPrimary HypercholesterolemiaKorea, Republic of
Clinical Trials on Policosanol
-
Wake Forest University Health SciencesCompleted
-
General Hospital of Chinese Armed Police ForcesChinese PLA General HospitalUnknown
-
Federico II UniversityRottapharmCompletedEndothelial Dysfunction | HyperlipidemiaItaly
-
Seoul National University Bundang HospitalDaewon Pharmaceutical Co., Ltd.RecruitingDiabetes Mellitus, Type 2 | Atherosclerosis | DyslipidemiaKorea, Republic of
-
Rush University Medical CenterNational Center for Complementary and Integrative Health (NCCIH)Completed
-
RottapharmFederico II UniversityCompleted
-
Federico II UniversityCompletedMetabolic SyndromeItaly
-
Shenyang Northern HospitalCompletedCoronary Artery DiseaseChina
-
James Backes, PharmDMarcor Development CorporationCompletedHigh CholesterolUnited States
-
University of Roma La SapienzaUnknownCoronary Artery DiseaseItaly