Clinical trials: Hypercholesterolemia and Mixed Dyslipidemia
- Condition Hypercholesterolemia and Mixed Dyslipidemia
- Funder type Industry (pharma, biotech, devices)
Hypercholesterolemia, Mixed Dyslipidemia
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic…
- Trial name
- MILOS (NCT04579367)
- Testing
- Bempedoic acid and/or its fixed-dose combination with ezetimibe
- Where
- 443 sites in Austria, Belgium and 6 more
- Volunteers
- 5,000 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Coronary Atherosclerosis, Mixed Dyslipidemia
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and…
- Conditions
- Coronary Atherosclerosis, Mixed Dyslipidemia, Hypercholesterolemia
- Trial name
- NCT07474649
- Testing
- Bempedoic acid, Ezetimibe, Rosuvastatin
- Where
- 12 sites in Germany, Italy and 1 more
- Volunteers
- 103 people
- Sponsor
- Daiichi Sankyo
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical…
- Trial name
- VICTORION REAL (NCT05399992)
- Testing
- Inclisiran
- Where
- 38 sites in Austria, China and 6 more
- Volunteers
- 847 people
- Sponsor
- Novartis Pharmaceuticals
Cardiovascular, Metabolic Disease
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.
- Conditions
- Cardiovascular, Metabolic Disease, Dyslipidemias, Lipid Disorder
- Trial name
- NCT07491172
- Testing
- CTX310
- Where
- 17 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- CRISPR Therapeutics AG
Primary Hypercholesterolemia, Mixed Dyslipidemia
A Clinical Study to Evaluate the Safety and Effectiveness 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…
- Trial name
- NCT06386419
- Testing
- inclisiran
- Where
- 9 sites in India
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Mixed Dyslipidemia, Hypercholesterolaemia
Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk.
- Trial name
- MEDICI (NCT07614958)
- Where
- United Kingdom
- Volunteers
- 426 people
- Sponsor
- A. Menarini International Licensing S.A.
Primary Hypercholesterolemia, Mixed Dyslipidemia
Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Compared to Monotherapy of DW5421A
This is a multicenter, randomized, double-blind, active-controlled, parallel, phase III clinical trial to evaluate the efficacy and safety of combination therapy of DW5421A/DW5421B versus monotherapy of DW5421A in patients with…
- Trial name
- NCT07444762
- Testing
- DW5421A, DW5421B
- Where
- South Korea
- Volunteers
- 184 people
- Sponsor
- Daewon Pharmaceutical Co., Ltd.
Hypercholesterolemia, Mixed Dyslipidemia
A Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients
The purpose of this study was to describe the effectiveness of inclisiran and proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in the real-world setting in China.
- Trial name
- NCT07409636
- Where
- United States
- Volunteers
- 11,991 people
- Sponsor
- Novartis Pharmaceuticals
Primary Hypercholesterolemia or Mixed Dyslipidemia
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein…
- Trial name
- V-Mono China (NCT05888103)
- Testing
- Inclisiran
- Where
- 28 sites in China
- Volunteers
- 207 people
- Sponsor
- Novartis Pharmaceuticals
Primary Hypercholesterolemia or Mixed Dyslipidemia
Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
This non-interventional study is a mandatory regular Post Marketing Surveillance(rPMS) granted by the Korean health authorities, and is conducted to assess the effectiveness and safety of Leqvio® Pre-filled Syringe(inclisiran…
- Trial name
- NCT06770543
- Testing
- Inclisiran
- Where
- 4 sites in South Korea
- Volunteers
- 1,500 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia and Mixed Dyslipidemia
A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hypercholesterolemia and Mixed Dyslipidemia
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in combination with a stable…
- Trial name
- NCT07278830
- Testing
- SAL003 140mg+Atorvastatin, SAL003 420mg+Atorvastatin
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of SAL003 in Combination With Statin Therapy in Patients With Hypercholesterolemia and Mixed Dyslipidemia
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Recombinant Fully Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) in Combination with Statin…
- Trial name
- NCT07253584
- Testing
- SAL003 140 mg
- Where
- China
- Volunteers
- 720 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Primary Hypercholesterolemia, Mixed Dyslipidemia
A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib
The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition
- Trial name
- NCT06314919
- Where
- South Korea
- Volunteers
- 8,606 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Hypercholesterolemia, Dyslipidemias
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W [≤31 days]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic…
- Conditions
- Hypercholesterolemia, Dyslipidemias, Primary Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
- Trial name
- NCT06568471
- Testing
- Lerodalcibep
- Where
- 18 sites in China
- Volunteers
- 210 people
- Sponsor
- Hasten Biopharmaceutical Co., Ltd.
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
This is a multi-center, prospective, comparative and non-interventional cohort study involving two cohorts, one cohort (Inclisiran Cohort) of patients treated with inclisiran in certain special territories in China (eg.
- Trial name
- NCT05118230
- Testing
- Inclisiran
- Where
- 2 sites in China
- Volunteers
- 61 people
- Sponsor
- Novartis Pharmaceuticals
Primary Hypercholesterolemia, Mixed Dyslipidemia
Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)
This is a multicenter, randomized, double-blind, placebo-controlled study in participants with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density lipoprotein-cholesterol (LDL-C) to assess the efficacy…
- Trial name
- NCT01274559
- Testing
- Extended-release niacin/laropiprant (ERN/LRPT)
- Volunteers
- 1,173 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Hypercholesterolemia, Mixed Dyslipidemia
Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
Cardiovascular disease (CVD), especially its management and associated costs, remains a major concern globally. There is a direct correlation between circulating levels of low-density lipoprotein cholesterol (LDL-C) and the…
- Trial name
- MILOS-Spain (NCT05798390)
- Testing
- Bempedoic acid and/or its fixed dose combination with ezetimibe
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Primary Hypercholesterolemia, Mixed Dyslipidemia
Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia
This study is being done to learn more about evolocumab in Chinese people with primary hypercholesterolemia or mixed dyslipidemia.
- Trial name
- NCT03433755
- Testing
- evolocumab
- Where
- 31 sites in China
- Volunteers
- 259 people
- Sponsor
- Amgen
Hypercholesterolemia, Mixed Dyslipidemia
SurveY Followed by a Retrospective Chart Review to Describe the Key Factors Leading to Physician's Decision to Treat Patients at High and Very High Cardiovascular Risk With hyperchOlesterolemia or Mixed Dyslipidemia With NUSTENDI®
In this study, a survey of office-based cardiologists and lipid management specialists will be conducted on treatment decisions for NUSTENDI® (bempedoic acid 180 mg fixed dose combination [FDC] with ezetimibe 10 mg) followed by a…
- Trial name
- NCT05546398
- Testing
- Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab, No study drug
- Where
- 63 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).
- Trial name
- NCT01879319
- Testing
- Evolocumab AMD, Evolocumab AI/pen
- Where
- 27 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Amgen