Status:
TERMINATED
Cholesterol-Lowering Effects of Policosanol
Lead Sponsor:
Drug Commission of the German Medical Association
Collaborating Sponsors:
Madaus AG
Conditions:
Hypercholesterolemia
Combined Hyperlipidemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
End Date :
July 1 2001
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00288483
Start Date
September 1 2000
End Date
July 1 2001
Last Update
July 21 2006
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.