Clinical trials: Lipid Metabolism Disorders
Hypercholesterolemia and Mixed Dyslipidemia
A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hypercholesterolemia and Mixed Dyslipidemia
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in combination with a stable…
- Trial name
- NCT07278830
- Testing
- SAL003 140mg+Atorvastatin, SAL003 420mg+Atorvastatin
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Metachromatic Leukodystrophy (MLD)
Multicenter Study of HGT-1110 Administered Intrathecally in Children With Metachromatic Leukodystrophy (MLD)
The purpose of this study is to determine the safety of ascending doses of HGT-1110 administered by intrathecal (IT) injection for 38 weeks (20 injections) in children with metachromatic leukodystrophy (MLD).
- Trial name
- IDEAMLD (NCT01510028)
- Testing
- Recombinant human arylsulfatase A
- Where
- 5 sites in Australia, Denmark and 3 more
- Volunteers
- 24 people
- Sponsor
- Shire
Hyperlipidemia, Hypertension
Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia
To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies in patients with hypertension and hyperlipidemia
- Trial name
- NCT01914432
- Testing
- YH16410, Rosuvastatin, Telmisartan
- Where
- South Korea
- Volunteers
- 210 people
- Sponsor
- Yuhan Corporation
Cardiovascular Risk Factors, Hyperlipidemia
European Study of Cardiovascular Risk
The main objective of this study is to describe the management of patients with cardiovascular risk factors in primary prevention among different European countries.
- Conditions
- Cardiovascular Risk Factors, Hyperlipidemia, Hypertension, Diabetes
- Trial name
- EURIKA (NCT00882336)
- Where
- 775 sites in Austria, Belgium and 10 more
- Volunteers
- 7,200 people
- Sponsor
- AstraZeneca
Gaucher Disease, Type 1, Type 1 Gaucher Disease
A Study of AT2101 (Afegostat Tartrate) in Adult Patients With Type 1 Gaucher Disease Currently Receiving Enzyme Replacement Therapy
This study was conducted to test the safety and tolerability of afegostat tartrate in participants with type 1 Gaucher disease already receiving enzyme replacement therapy.
- Conditions
- Gaucher Disease, Type 1, Type 1 Gaucher Disease, Gaucher Disease
- Trial name
- NCT00433147
- Testing
- Afegostat tartrate
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Amicus Therapeutics
Gangliosidoses, GM2, Gangliosidosis, GM1
A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of GM1 Gangliosidosis or GM2 Gangliosidosis
An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of GM1 gangliosidosis or GM2…
- Trial name
- NCT07082543
- Testing
- AZ-3102
- Where
- 27 sites in United States, Argentina and 12 more
- Volunteers
- 75 people
- Sponsor
- Azafaros B.V.
Dyslipidemias
Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled
To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.
- Trial name
- ROMANTIC (NCT03026933)
- Testing
- KI1107 4 Capsules, QD, Rosuvastatin Calcium 20 MG, QD
- Volunteers
- 215 people
- Sponsor
- Kuhnil Pharmaceutical Co., Ltd.
Hypercholesterolemia
Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia
Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive monitoring is required.
- Trial name
- PITCH (NCT01166633)
- Testing
- pitavastatin, atorvastatin
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- JW Pharmaceutical
Hypercholesterolemia
Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)
In the context of australian general practice, to determine the efficacy and safety of ezetimibe 10mg/statin 40mg coadministration in patients with uncontrolled cholesterol receiving statin 40mg or more.
- Trial name
- NCT00395473
- Testing
- MK0653, ezetimibe / Duration of Treatment: 6 Weeks
- Volunteers
- 141 people
- Sponsor
- Organon and Co
Hypertension, Dyslipidemia
Efficacy, Safety of Coadministered Pitavastatin and Valsartan in Patients With Hypertension and Dyslipidemia
Pitavastatin, a representative statin-series anti-dyslipidemic drug, and Valsartan, a representative ARB-series anti-hypertensive drug, have been authorized for use also in South Korea.
- Trial name
- COCTAIL (NCT01402843)
- Where
- 10 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- JW Pharmaceutical
Hypercholesterolemia, Hyperlipidemia, Familial Combined
Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.
- Trial name
- NCT00754039
- Testing
- colesevelam HCl tablets and fenofibrate tablets
- Where
- 10 sites in United States
- Volunteers
- 129 people
- Sponsor
- Daiichi Sankyo
Fabry Disease, Fabry Disease, Cardiac Variant
Long-Term Follow-up of Subjects Who Were Treated With ST-920
Long-term follow-up of subjects who received ST-920 in a previous trial (ST-920-201) and completed at least 52 weeks post-infusion follow-up in their primary protocol.
- Trial name
- NCT05039866
- Testing
- ST-920
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 32 people
- Sponsor
- Sangamo Therapeutics
Dyslipidemia, Coronary Heart Disease
Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
- Conditions
- Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
- Trial name
- NCT00300456
- Testing
- ABT-335, Simvastatin
- Where
- United States
- Volunteers
- 657 people
- Sponsor
- Abbott
Dyslipidemia & Hypertension
PK Study of Telmisartan/Rosuvastatin FDC Compared to Combination of Telmisartan and Rosuvastatin
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects…
- Trial name
- NCT01975961
- Testing
- Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC
- Where
- South Korea
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Gaucher Disease
Implementation and Evaluation of a Rare Disease Algorithm to Identify Persons at Risk of Gaucher Disease Using Data From Electronic Health Records (EHRs) in the United States (Project Searchlight)
This is a three-phase study comprising both retrospective and prospective components, as follows: Phase I: Deployment of Rare Disease Algorithm: A diagnostic screening algorithm was developed using advanced analytical methods to…
- Trial name
- NCT05908656
- Testing
- Investigational procedure
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Sanofi
Fabry Disease
Efficacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With Fabry Disease
This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease.
- Trial name
- MODIFY (NCT03425539)
- Testing
- Lucerastat
- Where
- 49 sites in United States, Australia and 12 more
- Volunteers
- 118 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Hypertriglyceridemia
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers.
- Trial name
- NCT00688857
- Testing
- Diazoxide choline
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Essentialis, Inc.
Healthy
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to compare the rate and extent of absorption of terbinafine hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet under fed conditions.
- Trial name
- NCT01286701
- Testing
- Terbinafine Hydrochloride Tablets, 250 mg
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
Patterns of Inclisiran Use in the Real World: An Analysis of US Databases
This was a retrospective observational cohort study of patients who initiated inclisiran, alirocumab, or evolocumab in a real-world setting in the United States.
- Trial name
- NCT07023445
- Where
- United States
- Volunteers
- 37,688 people
- Sponsor
- Novartis Pharmaceuticals
Dyslipidaemia
Evaluation of Food Supplementation in Subjects With Suboptimal Levels of LDL Cholesterol
This randomized, double-blind, placebo-controlled, parallel-group clinical study aims to evaluate the effect of a dietary supplement on LDL-cholesterol levels in healthy adults with suboptimal LDL-C values.
- Trial name
- NCT07492264
- Testing
- NUT2
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Cooper Consumer Health
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