Clinical trials: Lipids Metabolism
Hypercholesterolemia, Metabolic Syndrome
Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome
We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score.
- Trial name
- ProPit (NCT00640276)
- Testing
- pitavastatin, Lifestyle Modification
- Where
- 2 sites in South Korea
- Volunteers
- 187 people
- Sponsor
- JW Pharmaceutical
Atherosclerosis, Hypercholesterolemia
Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)
This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.
- Conditions
- Atherosclerosis, Hypercholesterolemia, Coronary Heart Disease
- Trial name
- NCT00651274
- Testing
- Ezetimibe
- Volunteers
- 144 people
- Sponsor
- Organon and Co
Primary Hypercholesterolemia
Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting
This study assessed the safety and efficacy of generic Rosuvastatin in reducing plasma low density lipoprotein (LDL) cholesterol in Lebanese adult patients (18 years or older) with dyslipidemia for both primary and secondary…
- Trial name
- NCT03516955
- Testing
- Rosuvastatin
- Volunteers
- 317 people
- Sponsor
- Hikma Pharmaceuticals LLC
Lipoprotein Lipase Deficiency, Familial Hyperlipoproteinemia Type 1
Glybera Registry, Lipoprotein Lipase Deficient (LPLD) Patients
Lipoprotein lipase deficiency (LPLD) is a rare autosomal recessive disorder, characterized by loss-of function mutations in the LPL gene, leading to the inability to produce functionally active lipoprotein lipase (LPL).
- Conditions
- Lipoprotein Lipase Deficiency, Familial Hyperlipoproteinemia Type 1, Familial Hyperchylomicronemia
- Trial name
- GENIALL (NCT03293810)
- Testing
- Observational study
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- UniQure Biopharma B.V.
Hypertriglyceridemia, Familial Chylomicronemia Syndrome
Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN0361 in Adult healthy subjects and Adult Hypertriglyceridemic Subjects.
- Trial name
- NCT06471543
- Testing
- RN0361
- Where
- 10 sites in United States, Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Ikaria Bioscience Pty Ltd
Hypercholesterolemia
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).
- Trial name
- NCT01730040
- Testing
- Alirocumab, Atorvastatin, Ezetimibe
- Where
- 97 sites in United States, Australia and 7 more
- Volunteers
- 355 people
- Sponsor
- Regeneron Pharmaceuticals
Dyslipidemias
A Study to Evaluate the Efficacy and Safety of CREZET Tablet
This observation study is to evaluate blood lipid-lowering effects and liver/renal safety, changes in HbA1c and FPG in patients with dyslipidemia who administered CREZET tablets for 24 weeks.
- Trial name
- NCT05889143
- Testing
- Ezetimibe/Rosuvastatin
- Where
- South Korea
- Volunteers
- 15,000 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy Volunteers
Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)
Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication
- Trial name
- NCT01702506
- Testing
- dacomitinib fasted, dacomitinib fed, dacomitinib+antacid
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hyperlipidemia
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0167 in Healthy Participants
This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SAL0167 following single and multiple dose administration in healthy participants.
- Trial name
- NCT07722299
- Testing
- SAL0167 group
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Hypercholesterolemia, LDL Cholesterol
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
This study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.
- Trial name
- NCT01859455
- Testing
- LGT209 50 mg, LGT209 300 mg, Statins (atorvastatin or simvastatin)
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Non-Insulin-Dependent, Hypertriglyceridemia
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and…
- Trial name
- NCT02113163
- Testing
- Metformin Eicosapentaenoate, Metformin HCl and Vascepa
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Thetis Pharmaceuticals LLC
Hypercholesterolaemia
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)
Primary Objectives: To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with…
- Trial name
- NCT02585778
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT), Antihyperglycemic Drug
- Where
- 110 sites in United States, Austria and 8 more
- Volunteers
- 517 people
- Sponsor
- Sanofi
Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease
A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab
This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.
- Conditions
- Cardiovascular Diseases, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Familial
- Trial name
- VICTORION-LEAP (NCT07543731)
- Where
- Switzerland
- Volunteers
- 5,995 people
- Sponsor
- Novartis Pharmaceuticals
Gaucher Disease
Lentiviral Vector Gene Therapy - The Guard1 Trial of AVR-RD-02 for Subjects With Type 1 Gaucher Disease
This was a multinational, open-label study to assess the safety and efficacy of AVR-RD-02 in approximately 8 to 16 subjects (male or female) who are ≥18 and ≤50 years of age and post pubertal at Screening with a confirmed…
- Trial name
- NCT04145037
- Testing
- AVR-RD-02
- Where
- 5 sites in United States, Canada
- Volunteers
- 8 people
- Sponsor
- AVROBIO
Healthy
CKD-391 Pharmacokinetic Study Phase I
A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
- Trial name
- NCT02501200
- Testing
- CKD-391, Atrovastatin and Ezetimibe combination therapy
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Hypertriglyceridemia
The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects
The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.
- Trial name
- NCT01486433
- Testing
- Simvastatin, acetylsalicylic acid (ASA), omefas
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hypercholesterolemia and Hyperlipidemia
Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers
In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration.
- Trial name
- NCT06837077
- Testing
- SHR-1209 single-site subcutaneous injection, SHR-1209 multiple-site subcutaneous injections
- Where
- China
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hypertriglyceridemia
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers.
- Trial name
- NCT00688857
- Testing
- Diazoxide choline
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Essentialis, Inc.
Gaucher's Disease
Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ
Primary Objective To evaluate the efficacy on hematologic manifestations of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ To evaluate the safety profile of imiglucerase in maximum dose in…
- Trial name
- SEED (NCT04656600)
- Testing
- Cerezyme® / Imiglucerase
- Where
- 5 sites in China
- Volunteers
- 12 people
- Sponsor
- Sanofi
Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease…
- Trial name
- NCT01516541
- Testing
- Background care, dalcetrapib
- Where
- 241 sites in United States, Australia and 11 more
- Volunteers
- 2,220 people
- Sponsor
- Hoffmann-La Roche
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