| 1 |
NCT02009787 |
Unknown † |
Efficacy Study of Vitamin D and Statins to Treat Hypercholesterolemia |
- Primary Hypercholesterolemia
|
- Drug: vitamin D3 tablets
- Drug: placebo tablets
|
Interventional |
Not Applicable |
- Shi Yang
- Chinese PLA General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- a change in serum total cholesterol level
- a change in serum triglycerides level
- differences in the incidences of treatment-emergent adverse events
|
56 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02009787 |
S2013-098-01 |
|
December 2013 |
January 2015 |
January 2015 |
December 12, 2013 |
December 12, 2013 |
|
- PLA General Hospital
Beijing, Beijing, China
|
| 2 |
NCT01243255 |
Completed |
Polish Survey on the Efficacy of the Hypercholesterolemia Treatment |
|
|
Observational |
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- establish the proportion of patients on lipid lowering pharmacological treatment reaching the LDL-C goals according to ESC 2007 guidelines in general.
- establish the proportion of patients on lipid lowering pharmacological treatment in primary prevention, reaching the LDL-C goals according to ESC 2007 guidelines for this sub-population
- establish the proportion of patients on lipid lowering pharmacological treatment in secondary prevention, reaching the LDL-C goals according to ESC 2007 guidelines for this sub-population
- identify determinants (patient and physician characteristics) for undertreatment of hypercholesterolemia.
|
1500 |
All |
18 Years and older (Adult, Senior) |
NCT01243255 |
NIS-CPL-DUM-2010/1 |
CEPHEUS |
December 2010 |
June 2011 |
June 2011 |
November 18, 2010 |
April 4, 2012 |
|
|
| 3 |
NCT01025388 |
Completed |
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia |
|
|
Observational |
|
- AstraZeneca
- ClinArt Company & Signen Clinical Discoveries
|
Industry / Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- To establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines, overall and by country.
- The proportion of patients reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III in the following sub-populations - Primary/secondary prevention patients - Patients with metabolic syndrome (according to NCEP III definition).
- The proportion of patients reaching the LDL-C goals according to the Third Joint European Task Force guidelines / national guidelines, in the following sub-populations:-Primary/secondary prevention patients -Patients with metabolic syndrome.
|
4053 |
All |
18 Years and older (Adult, Senior) |
NCT01025388 |
NIS-SA-CRE-2009/1 |
CEPHEUS |
November 2009 |
May 2010 |
May 2010 |
December 3, 2009 |
February 8, 2013 |
|
- Research Site
Riyadh, Central, Saudi Arabia - Research Site
Dammam, Eastern, Saudi Arabia - Research Site
Aljouf, North, Saudi Arabia - (and 2 more...)
|
| 4 |
NCT01206231 |
Completed |
An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia |
|
|
Observational |
|
|
Industry |
- Time Perspective: Prospective
|
- Proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines
- Proportion of patients on lipid-lowering pharmacological treatment reaching the non HDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines;
- Physicians' standard practice in managing patients with hypercholesterolemia (by using physicians' questionnaire);
- Local epidemiological date on patients with hypercholesterolemia (Demographic Data; Hypercholesterolemia management data: treatment, treatment changes)
|
330 |
All |
18 Years and older (Adult, Senior) |
NCT01206231 |
NIS-CRS-DUM-2010/1 |
|
December 2010 |
October 2011 |
October 2011 |
September 21, 2010 |
November 8, 2011 |
|
- Research Site
Belgrade, Serbia - Research Site
Cacak, Serbia - Research Site
Kragujevac, Serbia - (and 7 more...)
|
| 5 |
NCT00729027 |
Terminated |
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia |
|
- Drug: 25 mg/day AVE5530
- Drug: 50 mg/day AVE5530
- Drug: placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percent change from baseline in calculated LDL-C
- Percent change from baseline in Total-Cholesterol and Apo-B
|
1015 |
All |
18 Years and older (Adult, Senior) |
NCT00729027 |
EFC6910
EudraCT: 2008-001550 |
|
July 2008 |
June 2009 |
June 2009 |
August 6, 2008 |
May 16, 2016 |
|
- Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States - sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia - Sanofi-Aventis Administrative Office
Diegem, Belgium - (and 13 more...)
|
| 6 |
NCT00718965 |
Terminated |
Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary Hypercholesterolemia |
|
- Drug: AVE5530
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- percent change from baseline in calculated LDL-C
- percent change from baseline in total cholesterol and Apo-B
|
826 |
All |
18 Years and older (Adult, Senior) |
NCT00718965 |
EFC6909 |
|
July 2008 |
November 2008 |
June 2009 |
July 21, 2008 |
May 16, 2016 |
|
- Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States - Sanofi-Aventis Administrative Office
Puerto Rico, Puerto Rico
|
| 7 |
NCT02689934 |
Completed |
Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic in Patients With Moderate Hypercholesterolemia |
|
- Dietary Supplement: Lactoflorene colesterolo
- Dietary Supplement: Placebo lactoflorene colesterolo
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change in LDL-C From Baseline
- Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)
- Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins
- Changes in Vital Signs
|
33 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02689934 |
PROBIOTICO - BB536 |
|
April 2016 |
February 21, 2017 |
March 9, 2017 |
February 24, 2016 |
September 1, 2017 |
|
- Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda
Milano, Mi, Italy
|
| 8 |
NCT00741715 |
Terminated |
Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia |
|
- Drug: AVE5530
- Drug: atorvastatin
- Drug: placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percent change from baseline in calculated LDL-C
- Percent change from baseline in total cholesterol, HDL-C, TG, Apo-A1, Apo-B and CRP
|
1736 |
All |
18 Years and older (Adult, Senior) |
NCT00741715 |
EFC6911 |
|
August 2008 |
May 2009 |
June 2009 |
August 26, 2008 |
May 16, 2016 |
|
- Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States - Sanofi-Aventis Administrative Office
Puerto Rico, Puerto Rico
|
| 9 |
NCT01604733 |
Completed |
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia |
|
|
Observational |
|
|
Industry |
- Time Perspective: Cross-Sectional
|
- The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , overall and by country
- The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes
- The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Third Joint European Task Force guideline, in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes
- (and 3 more...)
|
1000 |
All |
18 Years and older (Adult, Senior) |
NCT01604733 |
NIS-EG-CRE-2010/01 |
CEPHEUS |
October 2010 |
June 2011 |
June 2011 |
May 24, 2012 |
May 24, 2012 |
|
|
| 10 |
NCT02772640 |
Recruiting |
Effectiveness of Treatment of Hypercholesterolemia With Rosuvastatin and Ezetimibe |
|
- Drug: Rosuvastatin and Ezetimibe morning or evening administration
|
Interventional |
Phase 4 |
- Collegium Medicum w Bydgoszczy
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in total cholesterol and LDL-Cholesterol
- Change in HDL-Cholesterol
- Change in triglycerides
- (and 11 more...)
|
200 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02772640 |
AMI9 |
ROSEZE |
March 2016 |
December 2016 |
December 2016 |
May 13, 2016 |
May 25, 2016 |
|
- Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kujawsko-Pomorskie, Poland
|
| 11 |
NCT03429998 |
Completed |
Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia |
|
- Drug: evolocumab
- Drug: evolocumab and LDL apheresis
- Procedure: LDL apheresis
|
Interventional |
Phase 3 |
- Hospital General Universitario Gregorio Marañon
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- decrease in LDL-cholesterol (mg/dl)
- Decrease apo-B (mg/dl) levels
- Decrease lipoprotein A (mg/dl) levels
- (and 7 more...)
|
9 |
All |
18 Years and older (Adult, Senior) |
NCT03429998 |
EVOLAFER01 |
|
April 1, 2017 |
January 28, 2018 |
January 28, 2018 |
February 12, 2018 |
February 12, 2018 |
|
- Hospital General Universitario Gregorio Marañon
Madrid, Spain
|
| 12 |
NCT03479983 |
Not yet recruiting
New |
Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia |
|
- Dietary Supplement: AMX160
- Dietary Supplement: Placebo
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in Total Cholesterol
- Change in Triglycerides
- Change in Low Density Lipoprotein Cholesterol
- (and 10 more...)
|
132 |
All |
18 Years to 65 Years (Adult) |
NCT03479983 |
AN-06ASE 0717H4-YSM01 |
|
April 2018 |
August 2018 |
August 2018 |
March 27, 2018 |
March 29, 2018 |
|
- Clinic of General and Invasive Cardiology University Hospital 1, YSMU
Yerevan, Armenia
|
| 13 |
NCT01979601 |
Completed |
Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia |
|
- Drug: LGT209
- Drug: Placebo
|
Interventional |
Phase 1 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of patients with adverse events, serious adverse events and death
- Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration in healthy volunteers
- Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) in healthy volunteers
- (and 15 more...)
|
74 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01979601 |
CLGT209X2101 |
|
December 2010 |
November 2011 |
November 2011 |
November 8, 2013 |
December 10, 2013 |
|
- Novartis Investigative Site
Miami Gardens, Florida, United States - Novartis Investigative Site
Fargo, North Dakota, United States
|
| 14 |
NCT02087917 |
Completed |
A 4-week, Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia |
- Primary Hypercholesterolemia
|
|
Interventional |
Phase 2 |
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Covance
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent change from baseline in LDL-C after 4 weeks of double-blind treatment
- Percentage of participants with reported adverse events during a 4-week period of treatment as a measure of safety and tolerability of HS-25
- Percent change from baseline in LDL-C after a 1 and 2-week period of double-blind treatment
- (and 3 more...)
|
376 |
All |
18 Years to 65 Years (Adult) |
NCT02087917 |
HS-25-III |
|
March 2014 |
September 2014 |
December 2014 |
March 14, 2014 |
January 6, 2015 |
|
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- West Hills, California, United States
- (and 24 more...)
|
| 15 |
NCT01890967 |
Completed
Has Results |
A Study of LY3015014 in Participants With High Cholesterol |
|
- Drug: LY3015014
- Drug: Placebo
- Drug: Statin
- Drug: Ezetimibe
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
- Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
- Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)
- (and 7 more...)
|
527 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01890967 |
14853
I5S-MC-EFJE |
|
June 2013 |
April 2014 |
June 2014 |
July 2, 2013 |
August 17, 2017 |
June 21, 2017 |
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Encino, California, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lancaster, California, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Spring Valley, California, United States - (and 46 more...)
|
| 16 |
NCT03381287 |
Recruiting |
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia |
|
- Drug: HTD1801 Tablets, 500mg
- Drug: HTD1801 Tablets, 1000mg
- Drug: HTD1801 Tablets, 2000mg
|
Interventional |
Phase 1
Phase 2 |
- HighTide Biopharma Pty Ltd
|
Industry |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- frequency and severity of adverse events
- Maximum plasma concentration of HTD1801 components (Cmax)
- Time to Cmax (Tmax)
- change of Low-density lipoprotein-C (LDL-C)
|
48 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03381287 |
HTD1801.PCT004 |
|
April 13, 2018 |
September 30, 2018 |
November 30, 2018 |
December 21, 2017 |
April 17, 2018 |
|
- Q-Pharm Pty Ltd.
Herston, Queensland, Australia - CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia - Linear Clinical Research
Nedlands, Western Australia, Australia
|
| 17 |
NCT01031277 |
Completed |
Centralized Pan-Middle East Survey on the Under-treatment of Hypercholesterolemia, Sub-study for the Gulf States |
|
|
Observational |
|
- AstraZeneca
- Clinart International
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- To establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III guidelines, overall and by country.
- Proportion patients on lipid-lowering drugs (LLD) reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III in subgroups: Primary/secondary prevention patients; Patients with metabolic syndrome ( NCEP III).
- Proportion patients on LLD reaching the LDL-C goals according to the Third Joint European Task Force guidelines/national guidelines, in the survey population and in sub-populations: Primary/secondary prevention patients; Patients with metabolic syndrome.
- To identify determinants (e.g. patient and physician characteristics, country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia.
|
1000 |
All |
18 Years and older (Adult, Senior) |
NCT01031277 |
NIS-GU-CRE-2009/1
SRP-CB-CRE-2006/01 |
CEPHEUS |
November 2009 |
July 2010 |
July 2010 |
December 14, 2009 |
May 25, 2011 |
|
- Research Site
Abu Dhabi, United Arab Emirates
|
| 18 |
NCT02693548 |
Unknown † |
The Spanish Familial Hypercholesterolaemia Cohort Study |
- Familial Hypercholesterolaemia
|
|
Observational |
|
- Fundación Hipercolesterolemia Familiar
- Instituto de Salud Carlos III
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Prognostic assessment: time to fatal or non-fatal cardiovascular event.
- LDL-cholesterol level (mg/dl) at entry and at follow-up
|
4141 |
All |
15 Years and older (Child, Adult, Senior) |
NCT02693548 |
SAFEHEART |
SAFEHEART |
January 2004 |
October 2017 |
October 2017 |
February 26, 2016 |
February 26, 2016 |
|
- Fundacion Hipercolesterolemia Familiar
Madrid, Spain
|
| 19 |
NCT02013713 |
Suspended |
French Observatory of Familial Hypercholesterolemia in Cardiology |
- Familial Hypercholesterolemia
|
|
Observational |
|
- French Cardiology Society
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Frequency of the Family Hypercholesterolemia in cardiology
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT02013713 |
12 449 |
FH Care |
November 2014 |
December 2022 |
December 2023 |
December 17, 2013 |
November 24, 2017 |
|
- European Hospital Georges Pompidou
Paris, France
|
| 20 |
NCT03175367 |
Recruiting |
Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia |
|
- Drug: Evinacumab
- Drug: Matching placebo
- Other: Background Lipid Modifying Therapy (LMT)
|
Interventional |
Phase 2 |
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent change in calculated low-density lipoprotein cholesterol (LDL-C) from baseline to week 16 in the intent-to-treat (ITT) population, using all LDL-C values regardless of adherence to treatment
- Percent change in Apolipoprotein B (ApoB) from baseline to week 16
- Percent change in non high-density lipoprotein cholesterol (HDL-C) from baseline to week 16
- (and 13 more...)
|
252 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03175367 |
R1500-CL-1643 |
|
February 2, 2018 |
October 29, 2019 |
May 5, 2020 |
June 5, 2017 |
March 22, 2018 |
|
- Preventive Cardiology Inc
Boca Raton, Florida, United States - Care Research Center Inc
Doral, Florida, United States - University of Maryland School of Medicine
Baltimore, Maryland, United States - (and 3 more...)
|
| 21 |
NCT01960244 |
Recruiting |
Study of Awareness and Detection of Familial Hypercholesterolemia |
|
|
Observational |
|
- The Familial Hypercholesterolemia Foundation
- Duke Clinical Research Institute
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Promote awareness of FH to increase the number of identified FH patients, reaching optimal level of disease management; target treatment levels for LDL cholesterol.
|
5000 |
All |
18 Years and older (Adult, Senior) |
NCT01960244 |
Pro00045568 |
CASCADE-FH |
October 2013 |
October 2020 |
October 2020 |
October 10, 2013 |
August 3, 2017 |
|
- Duke Clinical Research Institute
Durham, North Carolina, United States - Duke Clinical Research Institute
Durham, North Carolina, United States
|
| 22 |
NCT00867165 |
Completed
Has Results |
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522) |
- Primary Hypercholesterolemia
|
- Drug: ezetimibe
- Drug: Placebo
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
- Percentage Change From Baseline in Total Cholesterol (TC) at Week 12
- Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12
- (and 46 more...)
|
138 |
All |
6 Years to 10 Years (Child) |
NCT00867165 |
P05522
2008-006271-70
MK-0653-170 |
|
May 21, 2009 |
April 13, 2012 |
April 13, 2012 |
March 23, 2009 |
May 10, 2017 |
May 30, 2013 |
|
| 23 |
NCT02657759 |
Unknown † |
EFFECTS OF CARDICHOL, AN HERBAL DIETARY SUPPLEMENT, IN MODERATE HYPERCHOLESTEROLEMIA |
|
- Dietary Supplement: CARDICHOL
- Dietary Supplement: PLACEBO
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Change of the fasting blood LDL cholesterol NCEP concentration
- Change of the fasting blood LDL cholesterol concentration (NCEP and Friedewald estimation methods)
- Change of the fasting blood LDL cholesterol concentration (Friedewald estimation method)
- (and 9 more...)
|
50 |
All |
18 Years to 65 Years (Adult) |
NCT02657759 |
DPlantes |
CARDICHOL 1 |
December 2015 |
May 2016 |
May 2016 |
January 18, 2016 |
January 20, 2016 |
|
- Biofortis
Saint-Herblain, France
|
| 24 |
NCT03288038 |
Completed |
The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia |
|
- Drug: Rosuvastatin
- Drug: Ezetimibe
|
Interventional |
Phase 3 |
- Shin Poong Pharmaceutical Co. Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent change from baseline to 8 week in LDL-Cholesterol
- Percent change from baseline to 4 week in LDL-Cholesterol
- The change in the LDL-C level from the baseline to Week 4 and Week 8
- (and 3 more...)
|
382 |
All |
19 Years and older (Adult, Senior) |
NCT03288038 |
SP-RE-003 |
|
October 13, 2014 |
November 19, 2015 |
November 19, 2015 |
September 19, 2017 |
September 19, 2017 |
|
- Chungbuk National University Hospital
Cheongju-si, Korea, Republic of - Yeungnam University Medical Center
Daegu, Korea, Republic of - Chungnam National University Hospital
Daejeon, Korea, Republic of - (and 17 more...)
|
| 25 |
NCT00687492 |
Completed |
Centralized Pan-Asian Survey on the Under Treatment of Hypercholesterolemia |
|
|
Observational |
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- The number and percentage of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP Ⅲ guidelines(overall and by country)
- The number and percentage of subjects achieving the LDL-C goals according to the updated 2004 NCEP ATP Ⅲ guidelines for several subject subsets.
- The association between achievement of LDL-C goals,according to the updated 2004 NCEP ATPⅢ guidelines and patient and physician variables.
- The physician characteristics associated with the allocation of hypercholesterolemia treatment regime.
|
8000 |
All |
18 Years and older (Adult, Senior) |
NCT00687492 |
NIS-CAP-DUM-2008/1 |
CEPHEUS |
May 2008 |
December 2008 |
December 2008 |
May 30, 2008 |
December 2, 2010 |
|
- Research Site
Hong Kong, Hong Kong, China - Research Site
Semarang, Central Java, Indonesia - Research Site
Jakarta, DKI Jakarta, Indonesia - (and 56 more...)
|
| 26 |
NCT00945737 |
Completed |
A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia |
|
- Dietary Supplement: Soy protein; 25 grams/day
- Dietary Supplement: Control protein
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Basic Science
|
- The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C
- Changes in other lipid levels and other related biomarkers
|
60 |
All |
18 Years to 79 Years (Adult, Senior) |
NCT00945737 |
PRV-08009 |
PRV-08009 |
April 2009 |
August 2009 |
August 2009 |
July 24, 2009 |
June 7, 2012 |
|
- Provident Clinical Research
Addison, Illinois, United States - Provident Clinical Research
Bloomington, Indiana, United States
|
| 27 |
NCT02198703 |
Completed |
A Trial to Evaluate the Efficacy of AB-Life Probiotic Product on LDL-Cholesterol Reduction in Moderate Hypercholesterolemia |
- Moderate Hypercholesterolemia
|
- Dietary Supplement: Probiotics bacterial strains
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Change of the fasting blood LDL cholesterol concentration
- Change in fasting blood total cholesterol concentration
- Change in fasting blood LDLc concentration
- (and 30 more...)
|
104 |
All |
18 Years to 65 Years (Adult) |
NCT02198703 |
AB-Life study #3 |
|
September 2014 |
July 2015 |
July 2015 |
July 24, 2014 |
September 15, 2015 |
|
- Naturalpha
Lille, France - Biofortis
Saint-Herblain, France
|
| 28 |
NCT00542867 |
Completed |
Pan-European Survey on the Under Treatment of Hypercholesterolemia |
|
|
Observational |
|
|
Industry |
- Time Perspective: Prospective
|
- The number and percentage of patients achieving the LDL-C goals, according to the Third Joint European Task Force guidelines, overall and by country.
|
6500 |
All |
18 Years and older (Adult, Senior) |
NCT00542867 |
SRP-CB-CRE-2006/01 |
CEPHEUS |
January 2006 |
|
November 2007 |
October 12, 2007 |
November 20, 2007 |
|
|
| 29 |
NCT00092651 |
Completed |
A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038) |
|
- Drug: MK0653A, ezetimibe (+) simvastatin
- Drug: Comparators: simvastatin and ezetimibe
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Plasma LDL-C
- Plasma LDL-C, TG and HDL-C. The proportion of patients achieving LDL-C targets. Tolerability.
|
1398 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00092651 |
0653A-038
2004_048 |
|
September 2002 |
June 2003 |
June 2003 |
September 28, 2004 |
March 13, 2017 |
|
|
| 30 |
NCT03415178 |
Recruiting |
Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy |
|
- Drug: Alirocumab SAR236553
- Device: Current auto-injector device (AI)
- Device: New auto-injector device (SYDNEY)
|
Interventional |
Phase 3 |
- Sanofi
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- SYDNEY-associated product technical complaints (PTCs)
- Auto-injector associated PTCs (AI or SYDNEY) at initial supervised injection
- Injector experience questionnaire at initial supervised injection
- (and 9 more...)
|
66 |
All |
18 Years and older (Adult, Senior) |
NCT03415178 |
MSC14864
U1111-1186-3466 |
|
March 29, 2018 |
October 26, 2018 |
October 26, 2018 |
January 30, 2018 |
April 4, 2018 |
|
- Investigational Site Number 8400007
Jacksonville, Florida, United States
|
| 31 |
NCT02741245 |
Completed
Has Results |
A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832) |
|
- Drug: Ezetimibe 10 mg
- Drug: Rosuvastatin 2.5 mg
- Drug: Placebo for Ezetimibe
- Drug: Placebo for Rosuvastatin
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C)
- Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
- Percentage of Participants Who Had Study Drug Discontinued Due to Adverse Event
- (and 16 more...)
|
321 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT02741245 |
0653H-832
163336 |
|
June 9, 2016 |
January 18, 2017 |
January 18, 2017 |
April 18, 2016 |
March 9, 2018 |
March 9, 2018 |
|
| 32 |
NCT00092664 |
Completed |
An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED) |
|
- Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeks
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Plasma LDL-C.
- Plasma TG and HDL-C; proportion of patients achieving LDL-C targets; tolerability.
|
1104 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00092664 |
0653A-038 Extension
2004_043 |
|
January 2003 |
September 2003 |
September 2003 |
September 28, 2004 |
March 13, 2017 |
|
|
| 33 |
NCT02497833 |
Completed |
Retinoic Acid Supplementation and Subjects With Hypercholesterolemia |
|
- Dietary Supplement: retinoic acid
- Other: placebo
|
Interventional |
Early Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- PON1 activity
- Lp-PLA2 activity
|
130 |
All |
25 Years to 65 Years (Adult) |
NCT02497833 |
ZXYZM-2 |
|
November 2014 |
May 2015 |
May 2015 |
July 15, 2015 |
July 15, 2015 |
|
- Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)
Guangzhou, Guangdong, China
|
| 34 |
NCT00101439 |
Completed
Has Results |
A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED) |
|
- Drug: ezetimibe
- Drug: Comparator: placebo
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal
- Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal
|
58 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00101439 |
0653-072
MK-0653-072
2005_001 |
|
November 2005 |
October 2006 |
November 2006 |
January 11, 2005 |
April 4, 2017 |
June 10, 2016 |
|
| 35 |
NCT01027624 |
Completed |
Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia |
- Undertreatment of Hypercholesterolaemia
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III
- Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to the Fourth Joint European Task Force Guidelines/South African Guidelines in primary/secondary prevention patients, patients with metabolic syndrome
- Proportion of patients on lipid-lowering pharmacological treatment reaching the non HDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III Guidelines
|
3000 |
All |
18 Years and older (Adult, Senior) |
NCT01027624 |
NIS-CZA-DUM-2009/1 |
CEPHEUS |
November 2009 |
April 2010 |
April 2010 |
December 8, 2009 |
April 15, 2011 |
|
- Research Site
Johannesburg, South Africa
|
| 36 |
NCT03403374 |
Not yet recruiting |
Safety and Tolerability of Repatha in Indian Subjects With Homozygous Familial Hypercholesterolemia |
- Homozygous Familial Hypercholesterolemia HoFH
|
- Drug: Repatha® (evolocumab)
|
Interventional |
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with treatment related Adverse Events
- Change in LDC-C
- Change in ApoB
- Change in Lp(a)
|
30 |
All |
12 Years to 80 Years (Child, Adult, Senior) |
NCT03403374 |
20170199 |
|
May 28, 2018 |
August 12, 2020 |
August 12, 2020 |
January 18, 2018 |
April 3, 2018 |
|
|
| 37 |
NCT02608697 |
Completed |
A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia |
|
- Drug: CAT-2054
- Drug: Placebo
- Drug: Atorvastatin
|
Interventional |
Phase 2 |
- Catabasis Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent change in LDL-C from baseline in patients with hypercholesterolemia.
- Frequency of adverse events
- Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia
|
153 |
All |
18 Years to 74 Years (Adult, Senior) |
NCT02608697 |
CAT-2054-201 |
|
October 2015 |
May 2016 |
June 2016 |
November 20, 2015 |
June 20, 2017 |
|
- Muscle Shoals, Alabama, United States
- Huntington Park, California, United States
- Lomita, California, United States
- (and 31 more...)
|
| 38 |
NCT02550288 |
Completed
Has Results |
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383) |
|
- Drug: Ezetimibe 10 mg
- Drug: Atorvastatin 10 mg
- Drug: Placebo for Ezetimibe 10 mg tablet
- (and 2 more...)
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
- Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs)
- Percentage of Participants Who Experience 1 or More Gallbladder-related AEs
- (and 15 more...)
|
309 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT02550288 |
0653C-383
153060 |
|
September 29, 2015 |
May 30, 2016 |
May 30, 2016 |
September 15, 2015 |
November 13, 2017 |
June 21, 2017 |
|
| 39 |
NCT02715726 |
Active, not recruiting |
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia |
|
- Drug: alirocumab SAR236553 (REGN727)
- Drug: placebo for alirocumab
- Drug: ezetimibe
- (and 4 more...)
|
Interventional |
Phase 3 |
- Sanofi
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent change in calculated LDL-C in the intent-to-treat (ITT) population
- Percent change in calculated LDL-C in the modified ITT (mITT) population
- Percent change in calculated LDL-C
- (and 8 more...)
|
600 |
All |
18 Years and older (Adult, Senior) |
NCT02715726 |
EFC13889
U1111-1150-8859 |
ODYSSEY EAST |
July 27, 2016 |
August 10, 2018 |
August 10, 2018 |
March 22, 2016 |
March 29, 2018 |
|
- Investigational Site Number 1560027
Beijing, China - Investigational Site Number 1560043
Beijing, China - Investigational Site Number 1560039
Beijing, China - (and 59 more...)
|
| 40 |
NCT01406106 |
Unknown † |
Effect of Plant Sterols on the Lipid Profile of Patients With Hypercholesterolaemia |
|
- Dietary Supplement: Plant stanol esters
|
Interventional |
Not Applicable |
- Gerencia de Atención Primaria, Albacete
- Fundación para la Investigación Sanitaria en Castilla-La Mancha (FISCAM)
- Castilla-La Mancha Health Research Foundation.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in lipid profile
- Change in cardiovascular risk
- Adherence to the dairy product (liquid yoghurt)
- (and 11 more...)
|
182 |
All |
18 Years and older (Adult, Senior) |
NCT01406106 |
2009/001 |
|
January 2010 |
December 2011 |
December 2012 |
July 29, 2011 |
July 29, 2011 |
|
|
| 41 |
NCT03413462 |
Active, not recruiting |
Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia |
- Primary Hypercholesterolemia
|
- Drug: HS-25
- Drug: Placebo of HS-25
|
Interventional |
Phase 3 |
- Zhejiang Hisun Pharmaceutical Co. Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- LDL-C
- Non-HDL-C
- HDL-C
- (and 2 more...)
|
360 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03413462 |
HS-25-III-01 |
HS-25-III-01 |
April 12, 2016 |
April 20, 2018 |
April 20, 2018 |
January 29, 2018 |
March 13, 2018 |
|
|
| 42 |
NCT02260635 |
Terminated |
A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia |
|
- Drug: Evacetrapib
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent Change from Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification
- Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
- Percent Change from Baseline in LDL-C (direct)
- (and 4 more...)
|
54 |
All |
20 Years and older (Adult, Senior) |
NCT02260635 |
14503
I1V-JE-EIBI |
|
November 2014 |
July 2015 |
December 2015 |
October 9, 2014 |
August 26, 2016 |
|
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka, Japan - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, Japan
|
| 43 |
NCT02260648 |
Terminated |
A Study of Evacetrapib (LY2484595) in Combination With Atorvastatin in Japanese Participants With Primary Hypercholesterolemia |
|
- Drug: Evacetrapib
- Drug: Ezetimibe
- Drug: Atorvastatin
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent Change from Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification
- Percent Change from Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C)
- Percent Change from Baseline to Week 12 in LDL-C (direct)
- (and 4 more...)
|
68 |
All |
20 Years and older (Adult, Senior) |
NCT02260648 |
14501
I1V-JE-EIBG |
|
January 2015 |
November 2015 |
November 2015 |
October 9, 2014 |
August 26, 2016 |
|
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hyogo, Japan - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ibaragi, Japan - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ibaraki, Japan - (and 5 more...)
|
| 44 |
NCT03464682 |
Active, not recruiting |
Efficacy and Safety of HS-25 or in Combination With Atorvastatin in Chinese Adults With Primary Hypercholesterolemia |
- Primary Hypercholesterolemia
|
- Drug: HS-25 10mg
- Drug: HS-25 10mg combination with Atorvastatin
- Drug: HS-25 20mg combination with Atorvastatin
- (and 3 more...)
|
Interventional |
Phase 3 |
- Zhejiang Hisun Pharmaceutical Co. Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent change of LDL-C
- Percent change of non-HDL-C
- Percent change of HDL-C
- Percent change of TC, TG, Apo B, Apo Al
|
720 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03464682 |
HS-25-C-01 |
HS-25-C-01 |
February 28, 2015 |
August 28, 2018 |
May 28, 2019 |
March 14, 2018 |
March 14, 2018 |
|
|
| 45 |
NCT02584504 |
Completed |
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin |
|
- Drug: alirocumab SAR236553 (REGN727)
- Drug: placebo
- Drug: atorvastatin
- (and 3 more...)
|
Interventional |
Phase 3 |
- Sanofi
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent change in calculated LDL-C using all LDL-C values regardless of adherence to treatment
- Percent change in calculated LDL-C using all LDL-C values during the efficacy treatment period
- Percent change in calculated LDL-C
- (and 8 more...)
|
163 |
All |
20 Years and older (Adult, Senior) |
NCT02584504 |
EFC14305
U1111-1170-7697 |
ODYSSEY-NIPPON |
November 30, 2015 |
April 6, 2017 |
January 9, 2018 |
October 22, 2015 |
January 18, 2018 |
|
- Investigational Site Number 392028
Ageo-Shi, Japan - Investigational Site Number 392007
Chuo-Ku, Japan - Investigational Site Number 392029
Chuo-Ku, Japan - (and 27 more...)
|
| 46 |
NCT03152656 |
Recruiting |
A Registration Study for Familial Hypercholesterolemia in Taiwan |
- Familial Hypercholesterolemia
|
|
Observational |
|
- National Taiwan University Hospital
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Composite cardiovascular outcome
- With at least 1 cardiovascular risk factor.
|
1000 |
All |
Child, Adult, Senior |
NCT03152656 |
201505031RIND |
|
July 2015 |
June 2018 |
June 2018 |
May 15, 2017 |
May 15, 2017 |
|
|
| 47 |
NCT02585778 |
Completed |
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) |
|
- Drug: ALIROCUMAB SAR236553 (REGN727)
- Drug: placebo
- Drug: insulin
- (and 2 more...)
|
Interventional |
Phase 3 |
- Sanofi
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent change in calculated LDL-C in the intent to treat (ITT) population
- Number of patients with adverse events
- Percent change in calculated LDL-C in the modified ITT (mITT) population
- (and 14 more...)
|
517 |
All |
18 Years and older (Adult, Senior) |
NCT02585778 |
LPS14355
2015-000799-92
U1111-1172-4772 |
|
October 23, 2015 |
April 3, 2017 |
April 3, 2017 |
October 23, 2015 |
April 28, 2017 |
|
- Investigational Site Number 840020
Encino, California, United States - Investigational Site Number 840002
Fresno, California, United States - Investigational Site Number 840029
Oakland, California, United States - (and 107 more...)
|
| 48 |
NCT01982461 |
Unknown † |
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia. |
|
- Drug: Rosuvastatin
- Drug: Crestor®
|
Interventional |
Not Applicable |
- Pin Siang Medical Biotechnology Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks.
- The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1.
|
40 |
All |
20 Years to 85 Years (Adult, Senior) |
NCT01982461 |
PSMB102ROS10-01 |
|
November 2013 |
January 2014 |
|
November 13, 2013 |
November 13, 2013 |
|
- Tri-Service General Hospital
Taipei, Taiwan
|
| 49 |
NCT02476006 |
Active, not recruiting |
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE) |
|
- Drug: ALIROCUMAB SAR236553 (REGN727)
- Drug: placebo (for injection training only)
|
Interventional |
Phase 3 |
- Sanofi
- Regeneron Pharmaceuticals
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with adverse events
- Assessment of patient's acceptability of self-injection using Self Injection Assessment Questionnaire (SIAQ)
- Percent change from baseline in calculated LDL-C levels
- (and 3 more...)
|
1300 |
All |
18 Years and older (Adult, Senior) |
NCT02476006 |
LPS14245
2015-000620-28
U1111-1163-0984 |
|
June 23, 2015 |
March 27, 2019 |
March 27, 2019 |
June 19, 2015 |
August 14, 2017 |
|
- Investigational Site Number 040001
Graz, Austria - Investigational Site Number 040008
Innsbruck, Austria - Investigational Site Number 040005
Linz, Austria - (and 150 more...)
|
| 50 |
NCT02289963 |
Completed
Has Results |
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan |
|
- Drug: Placebo (for Alirocumab)
- Drug: Alirocumab
- Drug: Lipid-Modifying Therapy (LMT)
|
Interventional |
Phase 3 |
- Sanofi
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis
- Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
- Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
- (and 19 more...)
|
199 |
All |
18 Years and older (Adult, Senior) |
NCT02289963 |
EFC14074
U1111-1157-3294 |
|
January 2015 |
April 2016 |
April 2016 |
November 13, 2014 |
June 26, 2017 |
June 26, 2017 |
- Investigational Site Number 410009
Anyang-Si, Korea, Republic of - Investigational Site Number 410001
Anyang, Korea, Republic of - Investigational Site Number 410017
Busan, Korea, Republic of - (and 24 more...)
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