Clinical trials: Hypercholesterolaemia
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
Hypercholesterolaemia
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment…
- Trial name
- NCT05934292
- Testing
- Enlicitide Decanoate
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Coronary Artery Disease, Hypercholesterolemia, Hypertension
Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting
The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。
- Trial name
- ATTENTION (NCT02565615)
- Testing
- No intervention
- Where
- 54 sites in China
- Volunteers
- 5,115 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Homozygous Familial Hypercholesterolemia (HoFH)
A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH)
This first-in-human study is intended to evaluate the safety and preliminary effectiveness of AAV (Adeno-associated virus)-based liver-directed gene therapy in the treatment of adults with Homozygous Familial Hypercholesterolemia…
- Trial name
- NCT02651675
- Testing
- AAV directed hLDLR gene therapy
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 9 people
- Sponsor
- REGENXBIO Inc.
Hypercholesterolemia
A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea.
- Trial name
- NCT00496730
- Testing
- simvastatin (+) ezetimibe, Comparator: atorvastatin
- Volunteers
- 256 people
- Sponsor
- Organon and Co
ASCVD, Risk Factor, Cardiovascular
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy…
- Conditions
- ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
- Trial name
- ORION-11 (NCT03400800)
- Testing
- Inclisiran Sodium
- Where
- 70 sites in Czechia, Germany and 5 more
- Volunteers
- 1,617 people
- Sponsor
- The Medicines Company
Homozygous Familial Hypercholesterolemia
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
This study was a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- ORION-5 (NCT03851705)
- Testing
- Inclisiran Sodium for injection
- Where
- 13 sites in Hong Kong, Israel and 6 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia
A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial…
- Trial name
- NCT01583647
- Testing
- MK-0524A
- Volunteers
- 10 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia, Dyslipidemia
Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia
The primary objective of this study is to evaluate the safety and tolerability of repeated doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia.
- Trial name
- NCT01243151
- Testing
- PF-04950615 (RN316)
- Where
- 9 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pediatric Heterozygous Hypercholesterolemia
8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia
- Trial name
- NCT00739999
- Testing
- Atorvastatin
- Where
- 3 sites in Canada, Greece and 1 more
- Volunteers
- 39 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia, Familial
Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima…
- Trial name
- ACHIEVE (NCT00384293)
- Testing
- Comparator: niacin (+) laropiprant (MK0524A)
- Volunteers
- 937 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Open Label Study of Long Term Safety Evaluation of Alirocumab
Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492…
- Trial name
- ODYSSEY OLE (NCT01954394)
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 177 sites in United States, Argentina and 22 more
- Volunteers
- 986 people
- Sponsor
- Sanofi
Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
Long Term Safety Study of PRALUENT
The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very…
- Trial name
- NCT03694197
- Testing
- Praluent
- Where
- 123 sites in United States, Bulgaria and 4 more
- Volunteers
- 1,389 people
- Sponsor
- Regeneron Pharmaceuticals
Dyslipidemia, Hypercholesterolemia
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.
- Conditions
- Dyslipidemia, Hypercholesterolemia, High Cholesterol
- Trial name
- NCT05421078
- Testing
- Obicetrapib
- Where
- 10 sites in Japan
- Volunteers
- 102 people
- Sponsor
- NewAmsterdam Pharma
Hypercholesterolemia, Coronary Artery Disease
Tailored Communication to Reduce Cardiovascular Risk
The primary goal of the trial is to test the feasibility and efficacy of a cardiovascular disease quality improvement system that couples EMR-based patient identification with individually tailored patient messages.
- Conditions
- Hypercholesterolemia, Coronary Artery Disease, Dyslipidemia, Hypertension
- Trial name
- NCT01286311
- Testing
- Direct-to-patient tailored cardiovascular risk message system
- Where
- United States
- Volunteers
- 464 people
- Sponsor
- Northwestern University
Obesity, Hypertension
HealthMatters@24/7 eLearning for People Supporting Adults With Intellectual and Developmental Disabilities
The barriers faced by people with intellectual and developmental disabilities (IDD) begin in their mid to late 20s and often mirror the experiences of older adults (50+) living in the U.S.
- Conditions
- Obesity, Hypertension, Hypercholesterolemia, Hyperglycemia
- Trial name
- HM@24/7 (NCT03206164)
- Testing
- Asynchronous, eLearning Intervention
- Where
- United States
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
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
Hyperlipidemias
Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children
A multidisciplinary team of clinicians and researchers will conduct a pilot feasibility study to evaluate whether dietary intake of dry bean powder or rice bran or a combination is a helpful dietary recommendation to reduce total…
- Trial name
- NCT01911390
- Testing
- Bean powder, Rice bran, Control arm
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Poudre Valley Health System
Hyperlipidemia
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein…
- Trial name
- RUTHERFORD-2 (NCT01763918)
- Testing
- Evolocumab
- Where
- 39 sites in United States, Australia and 12 more
- Volunteers
- 331 people
- Sponsor
- Amgen
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).
- Trial name
- NCT01812707
- Testing
- Alirocumab, Atorvastatin
- Where
- 4 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Sanofi