Clinical trials: Primary Hypercholesterolaemia
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
A Study of SCH 58235 (Ezetimibe) When Added to Ongoing Therapy With a Statin in Participants With Primary Hypercholesterolemia, Known Coronary Heart Disease, or Multiple Cardiovascular Risk Factors (P02173)
This is a study to evaluate the lipid-altering efficacy, safety, and tolerability of ezetimibe when added to ongoing therapy with an 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) in participants…
- Trial name
- NCT03882905
- Testing
- Ezetimibe, Simivastatin, Statin
- Volunteers
- 769 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with…
- Trial name
- NCT00766688
- Testing
- AVE5530
- Where
- 13 sites in United States, Australia and 11 more
- Volunteers
- 643 people
- Sponsor
- Sanofi
Coronary Artery Disease, Hypercholesterolemia
A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma
The main aim of this trial is to demonstrate that Evolocumab plus routine lipid management is superior to routine lipid management alone in modifying plaque (non-calcified) volume as measured by Artificial Intelligence-enabled…
- Conditions
- Coronary Artery Disease, Hypercholesterolemia, Atheroma, Atherosclerotic Plaque
- Trial name
- NCT07803679
- Testing
- Evolocumab, Routine Lipid Management, Autoinjector
- Volunteers
- 308 people
- Sponsor
- Amgen
Hypercholesterolemia
Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with…
- Trial name
- NCT00653523
- Testing
- Ezetimibe, Simvastatin
- Volunteers
- 151 people
- Sponsor
- Organon and Co
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
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Vytorin Reexamination Study (0653A-174)
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting…
- Trial name
- NCT01070966
- Volunteers
- 2,089 people
- Sponsor
- Organon and Co
Hyperlipemia
The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as immunogenicity of JS002 treated repeatedly in patients…
- Trial name
- NCT04781114
- Testing
- JS002
- Where
- 57 sites in China
- Volunteers
- 806 people
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy
Primary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥…
- Trial name
- NCT01288443
- Testing
- Alirocumab, Atorvastatin
- Where
- 38 sites in United States
- Volunteers
- 183 people
- Sponsor
- Sanofi
Myalgia, Hypercholesterolemia
Study of the Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients Previously Intolerant to Statins Due to Statin-associated Myalgia (SAM)
The purpose of this study is to assess the incidence of statin-associated myalgia (SAM) with treatment with PPD10558 versus atorvastatin in patients previously intolerant to statins.
- Conditions
- Myalgia, Hypercholesterolemia, Hyperlipidemia
- Trial name
- NCT01279590
- Testing
- PPD10558, Atorvastatin
- Where
- 67 sites in United States
- Volunteers
- 282 people
- Sponsor
- Furiex Pharmaceuticals, Inc
Familial Hypercholesterolemia, Atherosclerosis
Advanced Lipoproptein Profiling and Cardiovascular Risk Stratification in Familial Hypercholesterolemia
Familial hypercholesterolaemia (FH) is a genetic disorder characterised by elevated plasma LDLC levels. The causal role of low-density lipoprotein cholesterol (LDLC) in the progression of cardiovascular disease (CVD) is…
- Trial name
- CARDIOMET (NCT05066932)
- Testing
- Additionnal blood samples
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Dyslipidemia
Safety and Efficacy of Lapaquistat Acetate Taken Alone and With Atorvastatin in Subjects With Primary Dyslipidemia
The purpose of this study is to evaluate the overall safety of Lapaquistat Acetate, once daily (QD), by itself or in combination with atorvastatin in subjects with primary dyslipidemia.
- Trial name
- NCT00487994
- Testing
- Lapaquistat acetate, Lapaquistat acetate and atorvastatin, Atorvastatin
- Where
- 128 sites in United States, Argentina and 15 more
- Volunteers
- 2,130 people
- Sponsor
- Takeda
Hypercholesterolemia
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background…
- Trial name
- NCT02023879
- Testing
- Alirocumab, Non-statin LMT, Diet Alone
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 233 people
- Sponsor
- Sanofi
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
Primary Hypercholesterolaemia
A Study to Evaluate the Safety and Pharmacokinetics of AD-228A Compared to Coadministration of AD-2281 and AD-2282
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228A in healthy subjects.
- Trial name
- NCT06858865
- Testing
- AD-228A, AD-2281 and AD-2282
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Primary Hypercholesterolemia
Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia
The purpose of this study is to investigate the safety and clinical efficacy of HGP1910 and HCP1903 in patients with primary hypercholesterolemia
- Trial name
- NCT04652349
- Testing
- HGP1910, HCP1903, HGP1909
- Where
- South Korea
- Volunteers
- 279 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Primary Hypercholesterolemia
A 4-week, Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia
To determine the efficacy of HS-25 (5, 10, 20 or 30 mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 4-week period of treatment in adults with primary hypercholesterolemia.
- Trial name
- NCT02087917
- Testing
- HS-25
- Where
- 27 sites in United States
- Volunteers
- 376 people
- Sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
Essential Hypertension, Primary Hypercholesterolemia
To Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe'.
This prospective study aims to observe changes in renal function and related parameters in patients with essential hypertension and primary hypercholesterolemia receiving either the combination of fimasartan and atorvastatin or…
- Trial name
- NCT07685054
- Volunteers
- 12,700 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Hypercholesteremia
Observational to Investigate the Efficacy of CRESTOR 5mg in Reaching LDL-C Target Goals in Patients Who Are at High Risk for a Cardiovascular Event
Observational study to investigate the use and efficacy of CRESTOR 5 mg in reaching LDL-C target goals in both statin naïve and statin treated primary and secondary prevention patients at high risk for a cardiovascular event.
- Trial name
- NCT00347217
- Where
- 215 sites in Netherlands
- Volunteers
- 3,840 people
- Sponsor
- AstraZeneca
Primary Hypercholesterolemia
Study to Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia.
- Trial name
- NCT05206578
- Testing
- AGT2, AGZ, AGT2, AGT4, AGZ
- Where
- South Korea
- Volunteers
- 264 people
- Sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd