Evaluation of the relationship between HDL quantity and HDL functionality in patients treated with HDL-C raising drugs - PROTOCOL BP20843B HDL FUNCTIONALITY

• Conditions: Primary hypercholesterolemia or mixed dyslipidemia; MedDRA version: 6.1Level: HLGTClassification code 10013317

• Registration Number: EUCTR2006-005747-29-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Male and post-menopausal female, lipid treatment naïve or previously treated patients2. Age 18 - 75 years (inclusive).3. Low < 40 mg/dL and normal HDL-C levels (between 40 and 59 mg/dL).4. LDL-C levels: >130 mg/dL, but < 190 mg/dL. 5. Triglyceride levels: >150 mg/dL, but <400 mg/dL. 6.Written informed consent (approved by the Independent Ethics Committee [IEC])obtained prior to any study specific screening procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects with secondary causes for Dyslipidemia (i.e. diabetes mellitus, hypothyroidism, obstructive liver disease, chronic renal failure).2. Body Mass Index (BMI) ³ 30 kg/m2.3. Patients requiring drugs that increase LDL-C and decrease HDL-C [progestins, anabolic steroids, and corticosteroids].4. Patients who drink alcohol excessively, defined as more than 21 units/week for males and more than 14 units/week for females. An alcohol unit is defined as 10 mL of absolute alcohol, 300 mL beer, 25 mL of a single spirit, or 100 mL of wine.5. History of or current alcohol or drug abuse.6. Use of an investigational drug in the 3 months prior to the screening visit. 7. Any clinically significant medical condition that could interfere with the conduct of the study.8. Systolic blood pressure ³ 160 mmHg and/or diastolic blood pressure ³ 100 mmHg at the screening visit.9. History of obstructive biliary disorders, pancreatitis, collagen diseases, or auto-immune diseases.10. History of malignancy during the 3 years prior to the screening visit.11. Known or suspected diagnosis of hepatitis or human immunodeficiency virus (HIV) infection.12. Known thyroid dysfunction.13. Any past history of cerebro-vascular accident or coronary events, including unstable angina, myocardial infarction, angioplasty, or coronary artery bypass graft.14. Females who are pregnant or breast feeding and females of child bearing potential. 15. Clinically significant hepatic, renal or cerebral disease.16. Hepatic transaminases or creatine phosphokinase >2 times the upper limit of normal (ULN) at the screening visit.17. Unable or unwilling to comply with the protocol requirements, or deemed by the investigator to be unfit for the study.18. Subjects contraindicated for PPAR-alfa agonist; or slow release niacin treatment according to approved label19. Lipid modifying drugs20. Any concomitant therapy known to alter any of the parameters to assess (i.e., aspirin, except when aspirin is indicated for the prevention of severe flushes induced by Niaspan) 21. Hypersensitivity to PPAR- alfa agonist; or slow release niacin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified