Clinical trials: Cholesterol; Metabolic Disorder
Healthy
Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults
The primary objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division (Kadian®) and Ligand® Pharmaceuticals Inc.
- Trial name
- NCT00782548
- Testing
- KADIAN (morphine sulfate sustained-release) capsules, Avinza (morphine sulfate sustained-release) capsules
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis 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
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
- Trial name
- NCT00652704
- Testing
- Doxycycline monohydrate, Monodox
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
To Determine Bioequivalence Under Fed Conditions
Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions
The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate 100 mg.
- Trial name
- NCT01380496
- Testing
- doxycycline monohydrate
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Primary Hypercholesterolemia, Dyslipidemia
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.
- Trial name
- NCT00249249
- Testing
- Pitavastatin, Atorvastatin
- Where
- 192 sites in Denmark, Finland and 11 more
- Volunteers
- 830 people
- Sponsor
- Kowa Research Europe
Dyslipidemia
Study of Undertreatment of Patients With Dyslipidemia in Bulgaria
The purpose of this study is to establish the proportion of Bulgarian patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth Joint European Task Force guidelines.
- Trial name
- CEPHEUS (NCT01075594)
- Where
- 15 sites in Bulgaria
- Volunteers
- 2,500 people
- Sponsor
- AstraZeneca
Hypercholesterolemia, Coronary Heart Disease
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular…
- Conditions
- Hypercholesterolemia, Coronary Heart Disease, Peripheral Vascular Disease, CVA
- Trial name
- CHALLENGE (NCT00574782)
- Volunteers
- 2,660 people
- Sponsor
- AstraZeneca
Dyslipidaemia
48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety
The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.
- Trial name
- NCT00654602
- Testing
- Rosuvastatin, Maintenance of specific diet
- Volunteers
- 1,500 people
- Sponsor
- AstraZeneca
Dyslipidemias
Effect of Saccharomyces Cerevisiae in LDL Cholesterol
The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.
- Trial name
- HONEY (NCT02990260)
- Testing
- Saccharomyces cerevisiae, Lynside Wall Basic
- Where
- France
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Lesaffre International
Hypercholesterolemia
A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)
The purpose of this study is to evaluate the ability of patients with intermediate risk of heart disease to appropriately use a Self-Management System.
- Trial name
- NCT00092846
- Testing
- MK0803, lovastatin, Self-Management System
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Fed
Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition
This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal…
- Trial name
- NCT01567501
- Testing
- Levocetirizine Dihydrochloride tablets 5 mg, Levocetirizine Dihydrochloride
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Hypercholesterolemia, Mixed Dyslipidemia
A Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients
The purpose of this study was to describe the effectiveness of inclisiran and proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in the real-world setting in China.
- Trial name
- NCT07409636
- Where
- United States
- Volunteers
- 11,991 people
- Sponsor
- Novartis Pharmaceuticals
Lysosomal Acid Lipase Deficiency, Wolman Disease
A Retrospective Natural History Study of Patients With Lysosomal Acid Lipase Deficiency/Wolman Phenotype
This is a Natural History study to characterize key aspects of the clinical course of lysosomal acid lipase (LAL) deficiency/Wolman phenotype in patients.
- Trial name
- NCT01358370
- Where
- 14 sites in United States, Canada and 3 more
- Volunteers
- 40 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Fed
Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01578265
- Testing
- Ondansetron Tablets USP 8 mg, Ondansetron Hydrochloride
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.