Clinical trials: Primary Hypercholesterolemia
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
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
Hypercholesterolemia
Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10 mg with simvastatin 20 mg), and Vytorin…
- Trial name
- NCT00413972
- Testing
- ezetimibe with simvastatin
- Volunteers
- 392 people
- Sponsor
- Organon and Co
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
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)
The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 40 mg in lowering…
- Trial name
- NCT01370603
- Testing
- Atorvastatin, Ezetimibe, Ezetimibe/atorvastatin
- Volunteers
- 328 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea.
- Trial name
- NCT00166504
- Testing
- ezetimibe (+) simvastatin, atorvastatin
- Volunteers
- 203 people
- Sponsor
- Organon and Co
Primary Hypercholesterolemia
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children >=6 to <=10 years…
- Trial name
- NCT00867165
- Testing
- ezetimibe
- Volunteers
- 138 people
- Sponsor
- Organon and Co
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
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
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
Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels…
- Trial name
- NCT00871351
- Testing
- Ezetimibe, Atorvastatin, Rosuvastatin
- Volunteers
- 125 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with…
- Trial name
- NCT00654095
- Testing
- Ezetimibe, atorvastatin
- Volunteers
- 146 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia…
- Trial name
- NCT01709513
- Testing
- Atorvastatin, Ezetimibe, Alirocumab
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 314 people
- Sponsor
- Regeneron Pharmaceuticals
Mood Disorders, Hypertension
One-Day Acceptance and Commitment Training Intervention in Primary Care Patients
The goal of this study is to 1) examine the feasibility and acceptability of a one-day Acceptance and Commitment Training + Illness Management (ACT-IM) intervention in patients with comorbid vascular disease risk factors and…
- Conditions
- Mood Disorders, Hypertension, Diabetes, Hypercholesterolemia
- Trial name
- NCT01879800
- Testing
- Acceptance and Commitment Therapy plus Illness Management
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Lilian N. Dindo
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
Hypercholesterolemia
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change…
- Trial name
- V-Mono (NCT05763875)
- Testing
- Inclisiran, Ezetimibe
- Where
- 42 sites in United States, Colombia and 3 more
- Volunteers
- 350 people
- Sponsor
- Novartis Pharmaceuticals
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
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Primary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in…
- Trial name
- NCT01288469
- Testing
- Alirocumab, Atorvastatin
- Where
- 20 sites in United States
- Volunteers
- 92 people
- Sponsor
- Sanofi