Clinical trials: Hypercholesterolemia
Heart Transplant
Impact of Evolocumab in Cardiac Transplant Patients With CAV
Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a transplanted heart. Evolocumab (Repatha) is an FDA-approved drug for lowering low density lipoprotein (LDL) in patients who have not received a…
- Trial name
- NCT03944577
- Testing
- Evolocumab
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Nebraska
Primary Hypercholesterolemia
Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia
The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.
- Trial name
- NCT00746811
- Testing
- P-OM3
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Provident Clinical Research
Familial Hypercholesterolemia
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.
- Trial name
- HAUSER-OLE (NCT02624869)
- Testing
- Evolocumab
- Where
- 46 sites in United States, Australia and 21 more
- Volunteers
- 163 people
- Sponsor
- Amgen
Homozygous Familial Hypercholesterolemia HoFH
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
To describe the safety and tolerability of evolocumab in participants with homozygous familial hypercholesterolemia (HoFH) in India. All participants will receive evolocumab over an 8-week period.
- Trial name
- RAMAN (NCT03403374)
- Testing
- evolocumab
- Where
- 12 sites in India
- Volunteers
- 30 people
- Sponsor
- Amgen
Severe Familial Hypercholesterolemia
Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.
- Trial name
- TAUSSIG (NCT01624142)
- Testing
- Evolocumab
- Where
- 44 sites in United States, Australia and 16 more
- Volunteers
- 300 people
- Sponsor
- Amgen
Dyslipidemia
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary…
- Trial name
- FOURIER (NCT01764633)
- Testing
- Evolocumab
- Where
- 1,284 sites in United States, Argentina and 47 more
- Volunteers
- 27,564 people
- Sponsor
- Amgen
Hypercholesterolemia
A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)
This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated hemoglobin (HbA1c) from baseline in the…
- Trial name
- NCT01611883
- Testing
- Ezetimibe
- Volunteers
- 152 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
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
Hypercholesterolemia, Coronary Disease
The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and…
- Trial name
- NCT00423579
- Testing
- Ezetimibe/Simvastatin 10/20 mg, simvastatin 40 mg
- Volunteers
- 120 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines
- Trial name
- NCT00442897
- Testing
- simvastatin (+) ezetimibe, Comparator: atorvastatin
- Volunteers
- 229 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED)
The purpose of this study is to determine the safety and tolerability of ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.
- Trial name
- BRAVO (NCT00654628)
- Testing
- ezetimibe (+) simvastatin
- Volunteers
- 173 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
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
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
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
Hypercholesterolemia
To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.
- Trial name
- NCT00271817
- Testing
- Comparator: ezetimibe/simvastatin + niacin (ER), Comparator: niacin (ER) tablet, Comparator: ezetimibe (+) simvastatin
- Volunteers
- 1,220 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Metabolic Syndrome
Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.
- Trial name
- NCT00409773
- Testing
- ezetimibe (+) simvastatin, Comparator: atorvastatin calcium
- Volunteers
- 1,143 people
- Sponsor
- Organon and Co
Hypercholesterolemia
A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)
To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C > 2mmol/l, who are able to attain the…
- Trial name
- NCT00462748
- Testing
- ezetimibe (+) simvastatin, Comparator: atorvastatin, Comparator: rosuvastatin
- Volunteers
- 786 people
- Sponsor
- Organon and Co
Hypercholesterolemia
A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
- Trial name
- NCT00479713
- Testing
- ezetimibe (+) simvastatin, Comparator : rosuvastatin calcium
- Volunteers
- 618 people
- Sponsor
- Organon and Co