Primary Hypercholesterolemia Clinical Trial
Official title:
A Real-world, Prospective, Multi-center, Open-label, Phase 4 Clinical Study to Evaluate the Safety and Effectiveness of Subcutaneous Injection of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium.
This is a prospective, multi-center, single-arm, open-label, interventional Phase 4 clinical study and will be conducted across several sites in India. The study consists of: - Open-label treatment period: The open-label treatment period will be of 270 days during which 3 single doses of inclisiran sodium will be administered subcutaneously (SC) on Day 1, Day 90, and Day 270, respectively. On Day 1/Dose 1 visit, the patients will be assessed by the Investigator for their eligibility to receive inclisiran sodium based on their medical history and previous lipid test reports. The study treatment i.e., inclisiran sodium will be prescribed as per the latest India Prescribing Information (PI). The assignment of the participant to the therapy will be decided within the current practice and the medical indication and will clearly be separated from the decision to include the participant in the study. - Safety follow-up period: The safety follow-up will be performed 30 days after each dose administration of the study treatment i.e., Day 30, Day 120, and Day 300. The follow-up on Day 30 and Day 120 visits will be conducted telephonically while Day 300 visit will be an onsite follow-up visit. This study will be conducted in compliance with Good Clinical Practices (GCP) including the Declaration of Helsinki and New Drugs and Clinical Trials (NDCT) Rules, 2019 requirements. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05559606 -
An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe
|
||
| Completed |
NCT03571087 -
Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia
|
Phase 3 | |
| Completed |
NCT00776321 -
Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
|
Phase 2 | |
| Recruiting |
NCT05399992 -
Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD
|
||
| Withdrawn |
NCT05798390 -
Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
|
||
| Completed |
NCT06448962 -
Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022
|
Phase 3 | |
| Completed |
NCT00724477 -
Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)
|
||
| Completed |
NCT00249249 -
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
|
Phase 3 | |
| Recruiting |
NCT05657574 -
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
|
Phase 3 | |
| Completed |
NCT02941848 -
Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT03516955 -
Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting
|
||
| Completed |
NCT01012219 -
A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
|
Phase 1 | |
| Completed |
NCT05131997 -
A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A
|
Phase 3 | |
| Terminated |
NCT03433755 -
Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia
|
Phase 3 | |
| Completed |
NCT00867165 -
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
|
Phase 3 | |
| Active, not recruiting |
NCT03952169 -
Effect of Probiotics on Lipid Management
|
N/A | |
| Terminated |
NCT01335997 -
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
|
Phase 3 | |
| Completed |
NCT02087917 -
A 4-week, Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia
|
Phase 2 | |
| Completed |
NCT00704535 -
Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
|
||
| Recruiting |
NCT06314919 -
A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib
|