Hypercholesterolemia Clinical Trial
Official title:
A Phase III Trial to Evaluate the Efficacy and Safety of Biweekly Alirocumab in Patients on a Stable Dialysis Regimen: The Alidial Study
12-week study of the efficacy and safety of alirocumab in patients maintained stably on hemodialysis or peritoneal dialysis. Measures of cholesterol levels, drug levels, PCSK9 levels, routine chemistry and cell counts, and biomarkers will be obtained at baseline and at weeks 4, 8, 10 and 12 weeks. Safety events will be obtained throughout the study.
Primary objective: The objective of this trial is to demonstrate the efficacy of alirocumab
150 mg every 2 weeks over 12 weeks on cholesterol levels.
Secondary objective: To assess the safety of treating chronic dialysis patients with
alirocumab 150 mg subcutaneously every 2 weeks for 12 weeks.
Secondary objective: To demonstrate the efficacy of alirocumab 150 mg every 2 weeks over 12
weeks on biomarkers.
Exploratory objective: To assess alirocumab drug levels in subjects maintained on
hemodialysis and peritoneal dialysis.
Methodology: Open-label, nonrandomized study
Number of patients Ten patients maintained on stable hemodialysis for a minimum of 3 months
and ten patients maintained on stable peritoneal dialysis for a minimum of 3 months
Test product: alirocumab 150 mg
Mode of administration: administered subcutaneously
Dosing interval: every 2 weeks
Duration of treatment: 12 weeks
Primary endpoint: Levels of LDL-cholesterol at 12 weeks
Secondary endpoints: Levels of total cholesterol, triglycerides, apoprotein B, Cystatin-C,
fibrinogen, hsCRP, IL-6, NGAL, NT-proBNP, soluble CD40 ligand, troponin T, VCAM
Safety criteria: Adverse events, Incidence and intensity of AE, including serious AE (SAE),
Withdrawal from study medication due to AE, Clinical relevant new findings or worsening of
existing conditions physical examination, Clinically relevant changes in laboratory
measurements from baseline
;
| 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 |
NCT01941836 -
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
|
Phase 2 | |
| Completed |
NCT01934608 -
The Effect of Synching Prescription Refills on Adherence
|
N/A | |
| 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 |
NCT01670734 -
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01678521 -
Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients
|
N/A | |
| 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 |
NCT01768403 -
Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia
|
N/A | |
| Completed |
NCT01575171 -
Using Nudges to Implement Comparative Effectiveness
|
N/A | |
| Completed |
NCT01478789 -
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
|
N/A |