Hypercholesterolaemia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia and LDL-C Higher or Equal to 160mg/dL With Their Lipid-Modifying Therapy
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9
(proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels
after 24 weeks of treatment in comparison with placebo.
Secondary Objectives:
- To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time
points
- To evaluate the effects of alirocumab on other lipid parameters
- To evaluate the safety and tolerability of alirocumab
The maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (LTS13463, NCT01954394) at the end of the treatment period. ;
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 |
NCT01935674 -
Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels
|
Phase 4 | |
| Completed |
NCT02890992 -
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
|
Phase 2 | |
| Completed |
NCT00653835 -
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
|
Phase 4 | |
| Recruiting |
NCT06008756 -
MK-0616 (Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
|
Phase 3 | |
| Completed |
NCT02585778 -
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)
|
Phase 3 | |
| Completed |
NCT00329173 -
PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.
|
Phase 3 | |
| Completed |
NCT04169386 -
A Study of PCSK9 Inhibitor AK102 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02770131 -
Chart Review of Repatha® in Subjects With Hyperlipidaemia
|
||
| Completed |
NCT03510884 -
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
|
Phase 3 | |
| Recruiting |
NCT06275724 -
Specified Drug-use Survey of Leqvio for s.c. Injection.
|
||
| Completed |
NCT03415178 -
Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
|
Phase 3 | |
| Completed |
NCT01779687 -
Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.
|
Phase 1 | |
| Completed |
NCT00328523 -
TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
|
Phase 3 | |
| Completed |
NCT05934292 -
MK-0616 (Oral PCSK9 Inhibitor) Renal Impairment Study 2 (MK-0616-020)
|
Phase 1 | |
| Completed |
NCT01257971 -
Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors
|
N/A | |
| Completed |
NCT00163163 -
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
|
Phase 3 | |
| Completed |
NCT01597700 -
Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.
|
Phase 1 | |
| Terminated |
NCT02906124 -
Study to Evaluate the Safety of Repatha® in Pregnancy
|
||
| Completed |
NCT01711749 -
Rosuvastatin Calcium Bioequivalence Study - Fast
|
Phase 1 | |
| Completed |
NCT02065180 -
The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome
|
Phase 4 |