Clinical trials: Hypercholesterolemia and Mixed Dyslipidemia
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
- Trial name
- NCT01849497
- Testing
- Evolocumab Pre-filled Syringe, Evolocumab AI/pen
- Where
- 26 sites in United States, Canada
- Volunteers
- 149 people
- Sponsor
- Amgen
Primary Hyperlipidemia and Mixed Dyslipidemia
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.
- Trial name
- FLOREY (NCT02189837)
- Testing
- Evolocumab, Atorvastatin
- Where
- 2 sites in Australia
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Amgen
Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in…
- Trial name
- AMG145 (NCT01953328)
- Testing
- Atorvastatin, Evolocumab
- Where
- 54 sites in Japan
- Volunteers
- 409 people
- Sponsor
- Amgen
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
Hyperlipidemia and Mixed Dyslipidemia
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
- Trial name
- OSLER-2 (NCT01854918)
- Testing
- Evolocumab, Standard of Care
- Where
- 363 sites in United States, Australia and 23 more
- Volunteers
- 3,681 people
- Sponsor
- Amgen
Dyslipidemia
A Study of LY2484595 in Patients With High LDL-C or Low HDL-C
The primary purpose of your participation in this study is to help answer the following research question(s) Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat…
- Trial name
- NCT01105975
- Testing
- LY2484595, Atorvastatin, Simvastatin
- Where
- 59 sites in United States, Denmark and 4 more
- Volunteers
- 398 people
- Sponsor
- Eli Lilly and Company
Hyperlipidemia
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from…
- Trial name
- LAPLACE-2 (NCT01763866)
- Testing
- Evolocumab, Ezetimibe, Atorvastatin
- Where
- 244 sites in United States, Australia and 19 more
- Volunteers
- 2,067 people
- Sponsor
- Amgen
Hypercholesterolemia, Mixed Dyslipidemia
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2…
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
- Trial name
- BANTING (NCT02739984)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Belgium and 5 more
- Volunteers
- 424 people
- Sponsor
- Amgen
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
Hypercholesterolemia, Dyslipidemia
Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia
The purpose of this study is to determine the non-inferiority between two different FDC (fixed-dose combination), measuring LDL-Cholesterol levels, in high risk patients with primary hypercholesterolemia or mixed dyslipidemia.
- Trial name
- LANCE (NCT01420549)
- Testing
- Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation., Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.
- Where
- 7 sites in Brazil
- Volunteers
- 129 people
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
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
Hypercholesterolemia, Hyperlipidemia
Effect of MK0524A on Cholesterol Levels (0524A-048)
The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.
- Trial name
- NCT00536510
- Testing
- laropiprant/niacin (MK0524A)
- Volunteers
- 646 people
- Sponsor
- Merck Sharp & Dohme LLC
Lipid Metabolism Disorders
Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in…
- Trial name
- NCT01551173
- Testing
- Fluvastatin sodium
- Where
- China
- Volunteers
- 436 people
- Sponsor
- Novartis Pharmaceuticals
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
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM)…
- Trial name
- NCT02833844
- Testing
- Evolocumab
- Where
- 78 sites in United States, Australia and 13 more
- Volunteers
- 467 people
- Sponsor
- Amgen
Primary Hypercholesterolemia, Mixed Hyperlipidemia
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary…
- Trial name
- NCT00941603
- Testing
- SCH 900271 15mg, SCH 900271
- Volunteers
- 619 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Hypercholesterolemia, Mixed Hyperlipidemia
A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)
This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary…
- Trial name
- NCT01012219
- Testing
- niacin (+) laropiprant, Comparator: aspirin, Comparator: clopidogrel
- Volunteers
- 36 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia, Mixed Dyslipidemia
Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119)
This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant (TREDAPTIVE) in usual practice in Korea according to the new product re-examination regulations of the Korean Food and Drug Administration.
- Trial name
- NCT01228019
- Testing
- Niacin (+) laropiprant
- Volunteers
- 1,166 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.
- Trial name
- NCT00479388
- Testing
- Comparator: simvastatin, niacin (+) laropiprant, Comparator: atorvastatin calcium
- Volunteers
- 1,216 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Hypercholesterolemia, Mixed Dyslipidemia
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets…
- Trial name
- NCT01335997
- Testing
- ER niacin/laropiprant (ERN/LRPT), ER niacin/laropiprant/simvastatin (ERN/LRPT/SIM), Simvastatin (SIM)
- Volunteers
- 1,139 people
- Sponsor
- Merck Sharp & Dohme LLC