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

Phase 1

• Conditions: Primary hypercholesterolemia or mixed dyslipidemia; MedDRA version: 9.1Level: LLTClassification code 10020604Term: Hypercholesterolemia; MedDRA version: 9.1Level: LLTClassification code 10058110Term: Dyslipidemia

• Registration Number: EUCTR2006-005747-29-FR
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-12
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

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

Inclusion Criteria

1. Male and post-menopausal female, lipid treatment naïve or previously treated patients
2. 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) = 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 = 160 mmHg and/or diastolic blood pressure = 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-a or slow release niacin treatment according to approved label
19. Lipid modifying drugs
20. 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 PPARa or slow release niacin

Study & Design

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