Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Alirocumab in Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as
add-on therapy to stable daily statin therapy with or without other lipid modifying therapy
in comparison with placebo after 24 weeks of treatment in heterozygous familial
hypercholesterolemia (HeFH) or high cardiovascular risk participants with
hypercholesterolemia.
Secondary Objectives:
- To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks
of treatment.
- To evaluate the effect of alirocumab on other lipid parameters.
- To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C
after 52 weeks of treatment.
- To evaluate the safety and tolerability of alirocumab.
- To evaluate the development of anti-alirocumab antibodies.
- To evaluate the pharmacokinetics of alirocumab.
Total duration per participant of approximately 63 weeks (14 months) (screening: 3 weeks, double-blind treatment period: 52 weeks, and follow-up period: 8 weeks). ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Recruiting |
NCT03947866 -
Ezetimibe-Rosuvastatin Evaluation Study
|
||
| Completed |
NCT01709513 -
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
|
Phase 3 | |
| Completed |
NCT01212900 -
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
|
Phase 4 | |
| Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
| Completed |
NCT02550288 -
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)
|
Phase 3 | |
| Completed |
NCT03929198 -
Translation of Pritikin Program to the Community
|
N/A | |
| Completed |
NCT04485793 -
Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia
|
N/A | |
| Completed |
NCT02341924 -
Validating the "Foods for Health" Portfolio of Functional Food Products
|
N/A | |
| Active, not recruiting |
NCT02223793 -
Vascular Lifestyle-Intervention and Screening in Pharmacy
|
N/A | |
| Completed |
NCT01934608 -
The Effect of Synching Prescription Refills on Adherence
|
N/A | |
| Completed |
NCT01941836 -
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
|
Phase 2 | |
| Recruiting |
NCT01705873 -
Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen
|
N/A | |
| Completed |
NCT01678521 -
Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients
|
N/A | |
| Completed |
NCT01670734 -
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01370603 -
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)
|
Phase 3 | |
| Completed |
NCT01370590 -
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)
|
Phase 3 | |
| Completed |
NCT01478789 -
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
|
N/A | |
| Completed |
NCT01575171 -
Using Nudges to Implement Comparative Effectiveness
|
N/A | |
| Completed |
NCT01446679 -
Special Drug Use-Results Survey of Lipitor Tablets
|
N/A |