Clinical trials: Statin Dose
Hypercholesterolemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in…
- Trial name
- GAUSS-4 (NCT02634580)
- Testing
- Evolocumab, Ezetimibe
- Where
- 35 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Amgen
Hypercholesterolemia
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is…
- Trial name
- NCT01592240
- Testing
- PBO, 200mg PF-04950615 (RN316), 300mg PF-04950615 (RN316)
- Where
- 74 sites in United States
- Volunteers
- 354 people
- Sponsor
- Pfizer
Hypercholesterolemia
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest…
- Trial name
- ODYSSEY-NIPPON (NCT02584504)
- Testing
- Alirocumab, Atorvastatin, Non-statin Lipid-Modifying Therapy
- Where
- 30 sites in Japan
- Volunteers
- 163 people
- Sponsor
- Sanofi
Hypercholesterolemia
Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)
This is a randomized, open label, parallel group comparison study. Following a 1-week screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to ongoing statin treatment (ezetimibe plus…
- Trial name
- NCT00652327
- Testing
- Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin), Double Statin (simvastatin, atorvastatin, or pravastatin)
- Volunteers
- 83 people
- Sponsor
- Organon and Co
Hypertriglyceridemia
Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)
The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride…
- Trial name
- ANCHOR (NCT01047501)
- Testing
- AMR101 (ethyl icosapentate) - 4 g/day, AMR101 (ethyl icosapentate) - 2 g/day
- Where
- 80 sites in United States
- Volunteers
- 702 people
- Sponsor
- Amarin Pharma Inc.
Dyslipidemias, Hypercholesterolemia
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk…
- Conditions
- Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD
- Trial name
- TANDEM (NCT06005597)
- Testing
- Combination Therapy, Monotherapy obicetrapib, Monotherapy ezetimibe
- Where
- 45 sites in United States
- Volunteers
- 407 people
- Sponsor
- NewAmsterdam Pharma
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with…
- Trial name
- GAUSS-3 (NCT01984424)
- Testing
- Atorvastatin, Ezetimibe
- Where
- 58 sites in United States, Australia and 11 more
- Volunteers
- 511 people
- Sponsor
- Amgen
Dyslipidemias, High Cholesterol
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia
- Trial name
- ROSE (NCT04753606)
- Testing
- Obicetrapib
- Where
- 19 sites in United States
- Volunteers
- 120 people
- Sponsor
- NewAmsterdam Pharma
Hypercholesterolemia
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin…
- Trial name
- NCT00145574
- Testing
- colesevelam HCl
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 194 people
- Sponsor
- Daiichi Sankyo
Healthy Volunteers, Hypercholesterolemia
A Study of LY3015014 in Healthy Participants With High Cholesterol
This is a study in healthy participants with high levels of "bad" cholesterol who are already taking a popular type of cholesterol-lowering medication called statins.
- Trial name
- NCT01671085
- Testing
- LY3015014
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Carotid Atherosclerosis
Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)
This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers
- Trial name
- MCAT (NCT00804843)
- Testing
- Atorvastatin/niacin extended-release, Atorvastatin, Simvastatin
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with…
- Trial name
- GAUSS (NCT01375764)
- Testing
- Evolocumab, Ezetimibe
- Where
- 42 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Amgen
Dyslipidemias, Hyperlipidemias
A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)
This is a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy, safety, tolerability, and pharmacokinetics (PK) of PF-07285557 (hereafter, vupanorsen) administered…
- Conditions
- Dyslipidemias, Hyperlipidemias, Hyperlipoproteinemias
- Trial name
- NCT04516291
- Testing
- Vupanorsen
- Where
- 114 sites in United States, Canada and 1 more
- Volunteers
- 286 people
- Sponsor
- Pfizer
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol…
- Trial name
- GAUSS-2 (NCT01763905)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 12 more
- Volunteers
- 307 people
- Sponsor
- Amgen
Atherosclerotic Vascular Disease
Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)
The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.
- Trial name
- NCT00703261
- Testing
- atorvastatin
- Volunteers
- 83 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Cardiovascular Disorder, Diabetes Mellitus
Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular…
- Trial name
- NCT00862251
- Testing
- ezetimibe (+) simvastatin, simvastatin 40 mg or atorvastatin 20 mg, Rosuvastatin
- Volunteers
- 808 people
- Sponsor
- Organon and Co
Hyperlipidemias
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol…
- Trial name
- NCT03337308
- Testing
- Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Bempedoic Acid, Ezetimibe
- Where
- 5 sites in United States
- Volunteers
- 382 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolemia, Dyslipidemia
A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
- Trial name
- NCT01342211
- Testing
- Statin, PF-04950615 (RN316), Satin
- Where
- 44 sites in United States, Canada
- Volunteers
- 93 people
- Sponsor
- Pfizer
Atherosclerotic Cardiovascular Disease
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease
This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that…
- Trial name
- NCT04992065
- Testing
- NNC0385-0434 A 15 mg, NNC0385-0434 A 40 mg, NNC0385-0434 A 100 mg
- Where
- 44 sites in United States, Belgium and 5 more
- Volunteers
- 267 people
- Sponsor
- Novo Nordisk A/S