DyslipidemiaNCT02304926

Effects of Simvastatin and Ezetimibe on Cardiovascular Risk Markers in Patients With Dyslipidemia

A study testing Simvastatin, Ezetimibe and Simvastatin + Ezetimibe in people with Dyslipidemia, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Dyslipidemia
What is being tested?: Simvastatin, Ezetimibe and Simvastatin + Ezetimibe
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: No sites listed yet
Study dates: Jan 2009to Dec 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

LDL cholesterol concentration of between 160-190 mg/dl in patients with less than 2 cardiovascular risk factors
LDL concentration of between 130-160 mg/dl in patients that presented 2 or more cardiovascular risk factors.
Cardiovascular risk factors were defined as: age (≥ 45 years in men and ≥55 years in women), a smoking habit, hypertension (≥140/90 mmHg), diabetes mellitus, a high-density lipoprotein (HDL) cholesterol concentration of ≤ 40mg/dl, and a family history of cardiovascular disease.

Who cannot join

Triglyceride concentration > 400 mg/dl
Diabetes Mellitus
Kidney, liver, or thyroid disease

About this study

Official title: Study of Lipoprotein Subfractions, Inflammation, Oxidative Stress and Endothelial Function After Treatment With Simvastatin and Ezetimibe Administered Alone and in Combination in Hyperlipidemic Patients

Coadministration of drugs is common in the pharmacologic treatment of dyslipidemia, with statins and ezetimibe generally constituting the medication of choice. By acting at different levels, the combination of these drugs allows the therapeutic objective to be achieved. However, it is not known how these drugs qualitatively affect the composition of lipoprotein subfractions, which differ in size and atherogenic potential. The investigators set out to evaluate this effect as well as their effects on inflammatory, oxidative stress and endothelial function parameters.

Read the detailed description

The study consisted of a randomised parallel trial and took place during a period of 2 months. A total of 42 hyperlipidemic patients were randomly assigned to one of 2 groups: one received simvastatin (40 mg/day) and the other received ezetimibe (10 mg/day) for 4 weeks, after which both groups were administered combined therapy for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.

Conditions: Dyslipidemia
Being tested: Simvastatin, Ezetimibe, Simvastatin + Ezetimibe
Keywords: Dyslipidemia, Simvastatin, Ezetimibe, Lipid profile, Inflammation, Oxidative stress, Endothelial function
Medical subject headings: Dyslipidemias, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SimvastatinDrug
simvastatin (40 mg/day) for 4 weeks
EzetimibeDrug
ezetimibe (10 mg/day) for 4 weeks
Simvastatin + EzetimibeDrug
combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period

Study groups in NCT02304926
Study group	Role	What they receive
Simvastatin	Experimental	Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated. Receives: Drug: Simvastatin; Drug: Simvastatin + Ezetimibe
Ezetimibe	Experimental	Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated. Receives: Drug: Ezetimibe; Drug: Simvastatin + Ezetimibe

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Cholesterol Before and After Simvastatin/Ezetimibe Administration
Total cholesterol concentration was measured by enzymatic assay
Measured: Baseline, 4 weeks and 8 weeks
Low-density Lipoprotein Cholesterol (LDLc) Before and After Simvastatin/Ezetimibe Administration
Low-density lipoprotein cholesterol (LDLc) concentration was calculated using the method of Friedewald.
Measured: Baseline, 4 weeks and 8 weeks
High-density Lipoprotein Cholesterol (HDLc) Before and After Simvastatin/Ezetimibe Administration
High-density lipoprotein cholesterol (HDLc) concentration was measured using a direct method
Measured: Baseline, 4 weeks and 8 weeks
Triglycerides Before and After Simvastatin/Ezetimibe Administration
Triglyceride concentration were measured by enzymatic assay
Measured: Baseline, 4 weeks and 8 weeks
Non-HDL Cholesterol Before and After Simvastatin/Ezetimibe Administration
Non-HDLc concentration was obtained by calculating the difference between total cholesterol and HDLc
Measured: Baseline, 4 weeks and 8 weeks
Low Density Lipoprotein Size Before and After Simvastatin/Ezetimibe Administration
LDL subfractions were separated by high-resolution polyacrylamide gel tubes using the Lipoprint® system. The LDL electrophoretic profile allows 2 patterns to be defined: pattern A or large and buoyant LDL, and pattern non-A or small and dense LDL.
Measured: Baseline, 4 weeks and 8 weeks
Apolipoprotein B Before and After Simvastatin/Ezetimibe Administration
Levels of apolipoprotein B were determined by inmunonephelometry
Measured: Baseline, 4 weeks and 8 weeks

Secondary outcomes (13)

Levels of High-sensitive C-reactive Protein (hsCRP) Before and After Simvastatin/Ezetimibe Administration
Levels of high-sensitive C-reactive protein (hsCRP) were analysed by a latex-enhanced inmunonephelometric assay
Measured: Baseline, 4 weeks and 8 weeks
Levels of Interleukin-6 (IL-6) Before and After Simvastatin/Ezetimibe Administration
Levels of proinflammatory cytokines (interleukin-6 (IL-6)) were analysed with a Luminex® 200™ system
Measured: Baseline, 4 weeks and 8 weeks
Levels of Tumor Necrosis Factor α (TNF-α) Before and After Simvastatin/Ezetimibe Administration
Levels of proinflammatory cytokines (tumor necrosis factor α (TNF-α)) were analysed with a Luminex® 200™ system
Measured: Baseline, 4 weeks and 8 weeks
Mitochondrial Oxygen (O2) Consumption Before and After Simvastatin/Ezetimibe Administration
Oxidative stress markers (mitochondrial oxygen (O2) consumption) was measured at baseline and after treatment by Clark electrode
Measured: Baseline, 4 weeks and 8 weeks
Reactive Oxygen Species (ROS) Production Before and After Simvastatin/Ezetimibe Administration
Oxidative stress markers (Reactive oxygen species (ROS) production) was measured at baseline and after treatment by fluorometric techniques
Measured: Baseline, 4 weeks and 8 weeks
Membrane Potential Before and After Simvastatin/Ezetimibe Administration
Oxidative stress markers (membrane potential) was measured at baseline and after treatment by fluorometric techniques
Measured: Baseline, 4 weeks and 8 weeks
Levels of Glutathione (GSH) Before and After Simvastatin/Ezetimibe Administration
Oxidative stress markers (levels of glutathione (GSH)) was measured at baseline and after treatment by fluorometric techniques
Measured: Baseline, 4 weeks and 8 weeks
Leukocyte Rolling Flux Before and After Simvastatin/Ezetimibe Administration
Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Leukocyte rolling was estimated as the number of leukocytes rolling over 100 μm2 of the endothelial monolayer during a 1-min period.
Measured: Baseline, 4 weeks and 8 weeks
Leukocyte Adhesion Before and After Simvastatin/Ezetimibe Administration
Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Adhesion was evaluated by counting the number of polymorphonuclear cells that maintained stable contact with human umbilical vein endothelial cells (HUVEC) for 30 seconds.
Measured: Baseline, 4 weeks and 8 weeks
Leukocyte Rolling Velocity Before and After Simvastatin/Ezetimibe Administration
Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy.The rolling velocity in the field of focus was determined by measuring the time required by 20 consecutive leukocytes to cover a distance of 100 μm.
Measured: Baseline, 4 weeks and 8 weeks
Levels of Vascular Cell Adhesion Molecule 1 (VCAM-1) Before and After Simvastatin/Ezetimibe Administration
The vascular cell adhesion molecule 1 (VCAM-1) was evaluated in serum by Luminex® 200™ system
Measured: Baseline, 4 weeks and 8 weeks
Levels of Intercellular Adhesion Molecule 1 (ICAM-1) Before and After Simvastatin/Ezetimibe Administration
The intercellular adhesion molecule 1 (ICAM-1) was evaluated in serum by Luminex® 200™ system
Measured: Baseline, 4 weeks and 8 weeks
Levels of E-selectin Before and After Simvastatin/Ezetimibe Administration
E-selectin was evaluated in serum by Luminex® 200™ system
Measured: Baseline, 4 weeks and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Dec 2011

First posted2 Dec 2014 (estimated)
Study startJan 2009
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for DyslipidemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02304926
Sponsor's protocol ID: SIM-EZE-2009-01
Status last verified: Feb 2018
First submitted: 25 Nov 2014
Last updated: 8 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Berneis K, Rizzo M, Berthold HK, Spinas GA, Krone W, Gouni-Berthold I. Ezetimibe alone or in combination with simvastatin increases small dense low-density lipoproteins in healthy men: a randomized trial. Eur Heart J. 2010 Jul;31(13):1633-9. doi: 10.1093/eurheartj/ehq181. Epub 2010 Jun 6.
PubMed 20525999
Florentin M, Liberopoulos EN, Moutzouri E, Rizos CV, Tselepis AD, Elisaf MS. The effect of simvastatin alone versus simvastatin plus ezetimibe on the concentration of small dense low-density lipoprotein cholesterol in subjects with primary hypercholesterolemia. Curr Med Res Opin. 2011 Mar;27(3):685-92. doi: 10.1185/03007995.2010.546394. Epub 2011 Jan 27.
PubMed 21271793
Bays HE, Ose L, Fraser N, Tribble DL, Quinto K, Reyes R, Johnson-Levonas AO, Sapre A, Donahue SR; Ezetimibe Study Group. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther. 2004 Nov;26(11):1758-73. doi: 10.1016/j.clinthera.2004.11.016.
PubMed 15639688

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
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Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
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Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Lipoprotein Subfractions, Inflammation, Oxidative Stress and Endothelial Function After Treatment With Simvastatin and Ezetimibe Administered Alone and in Combination in Hyperlipidemic Patients
ClinicalTrials.gov ID: NCT02304926
Acronym / sponsor ID: SIM-EZE-2009-01
Conditions: Dyslipidemia
Keywords: Dyslipidemia, Simvastatin, Ezetimibe, Lipid profile, Inflammation, Oxidative stress, Endothelial function
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
Study start: Jan 2009
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 2 Dec 2014 (estimated)
Results: Posted 21 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Simvastatin	Experimental	Drug: Simvastatin, Drug: Simvastatin + EzetimibeHyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.
Ezetimibe	Experimental	Drug: Ezetimibe, Drug: Simvastatin + EzetimibeHyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

LDL cholesterol concentration of between 160-190 mg/dl in patients with less than 2 cardiovascular risk factors
LDL concentration of between 130-160 mg/dl in patients that presented 2 or more cardiovascular risk factors.
Cardiovascular risk factors were defined as: age (≥ 45 years in men and ≥55 years in women), a smoking habit, hypertension (≥140/90 mmHg), diabetes mellitus, a high-density lipoprotein (HDL) cholesterol concentration of ≤ 40mg/dl, and a family history of cardiovascular disease.

Key exclusion criteria (3 listed)

Triglyceride concentration > 400 mg/dl
Diabetes Mellitus
Kidney, liver, or thyroid disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Simvastatinsimvastatin (40 mg/day) for 4 weeks	Drug	Simvastatin
Ezetimibeezetimibe (10 mg/day) for 4 weeks	Drug	Ezetimibe
Simvastatin + Ezetimibecombined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period	Drug	Ezetimibe, Simvastatin

Primary outcome

Total Cholesterol Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Total cholesterol concentration was measured by enzymatic assay
Low-density Lipoprotein Cholesterol (LDLc) Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Low-density lipoprotein cholesterol (LDLc) concentration was calculated using the method of Friedewald.
High-density Lipoprotein Cholesterol (HDLc) Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
High-density lipoprotein cholesterol (HDLc) concentration was measured using a direct method
Triglycerides Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Triglyceride concentration were measured by enzymatic assay
Non-HDL Cholesterol Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Non-HDLc concentration was obtained by calculating the difference between total cholesterol and HDLc
Low Density Lipoprotein Size Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
LDL subfractions were separated by high-resolution polyacrylamide gel tubes using the Lipoprint® system. The LDL electrophoretic profile allows 2 patterns to be defined: pattern A or large and buoyant LDL, and pattern non-A or small and dense LDL.
Apolipoprotein B Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Levels of apolipoprotein B were determined by inmunonephelometry

13 secondary outcomes

Levels of High-sensitive C-reactive Protein (hsCRP) Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Levels of Interleukin-6 (IL-6) Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Levels of Tumor Necrosis Factor α (TNF-α) Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Mitochondrial Oxygen (O2) Consumption Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Reactive Oxygen Species (ROS) Production Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Membrane Potential Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Levels of Glutathione (GSH) Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Leukocyte Rolling Flux Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Leukocyte Adhesion Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Leukocyte Rolling Velocity Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Levels of Vascular Cell Adhesion Molecule 1 (VCAM-1) Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Levels of Intercellular Adhesion Molecule 1 (ICAM-1) Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks
Levels of E-selectin Before and After Simvastatin/Ezetimibe Administration
Time frame: Baseline, 4 weeks and 8 weeks

Results and safety

Results posted to the registry on 21 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Simvastatin	22	20
Ezetimibe	20	19

Primary outcome: Total Cholesterol Before and After Simvastatin/Ezetimibe Administration

Time frame: Baseline, 4 weeks and 8 weeks. Mean (Standard Deviation). Unit: mg/dl

Measure	Simvastatin n = 20	Ezetimibe n = 19
Baseline	255 (34)	253 (26)
4 weeks	180 (29)	215 (33)
8 weeks	173 (38)	169 (39)

Simvastatin vs Ezetimibe: p <0.05, ANOVA

Primary outcome: Low-density Lipoprotein Cholesterol (LDLc) Before and After Simvastatin/Ezetimibe Administration

Time frame: Baseline, 4 weeks and 8 weeks. Mean (Standard Deviation). Unit: mg/dl

Measure	Simvastatin n = 20	Ezetimibe n = 19
Baseline	178 (26)	172 (29)
4 weeks	106 (18)	138 (32)
8 weeks	98 (28)	94 (36)

Simvastatin vs Ezetimibe: p <0.05, ANOVA

Primary outcome: High-density Lipoprotein Cholesterol (HDLc) Before and After Simvastatin/Ezetimibe Administration

Time frame: Baseline, 4 weeks and 8 weeks. Mean (Standard Deviation). Unit: mg/dl

Measure	Simvastatin n = 20	Ezetimibe n = 19
Baseline	47 (11)	53 (15)
4 weeks	50 (13)	53 (11)
8 weeks	51 (13)	53 (13)

Simvastatin vs Ezetimibe: p <0.05, ANOVA

Primary outcome: Triglycerides Before and After Simvastatin/Ezetimibe Administration

Time frame: Baseline, 4 weeks and 8 weeks. Median (Inter-Quartile Range). Unit: mg/dl

Measure	Simvastatin n = 20	Ezetimibe n = 19
Baseline	141 (104 to 168)	120 (81 to 184)
4 weeks	117 (82 to 136)	105 (81 to 142)
8 weeks	104 (82 to 146)	81 (61 to 137)

Simvastatin vs Ezetimibe: p <0.05, ANOVA

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were not collected. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adverse Events Were Not Collected	0 of 39 (0%)	0 of 39 (0%)	Not reported
EG001	0 of 39 (0%)	0 of 39 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20525999Berneis K, Rizzo M, Berthold HK, Spinas GA, Krone W, Gouni-Berthold I. Ezetimibe alone or in combination with simvastatin increases small dense low-density lipoproteins in healthy men: a randomized trial. Eur Heart J. 2010 Jul;31(13):1633-9. doi: 10.1093/eurheartj/ehq181. Epub 2010 Jun 6.
Background: PubMed 21271793Florentin M, Liberopoulos EN, Moutzouri E, Rizos CV, Tselepis AD, Elisaf MS. The effect of simvastatin alone versus simvastatin plus ezetimibe on the concentration of small dense low-density lipoprotein cholesterol in subjects with primary hypercholesterolemia. Curr Med Res Opin. 2011 Mar;27(3):685-92. doi: 10.1185/03007995.2010.546394. Epub 2011 Jan 27.
Background: PubMed 15639688Bays HE, Ose L, Fraser N, Tribble DL, Quinto K, Reyes R, Johnson-Levonas AO, Sapre A, Donahue SR; Ezetimibe Study Group. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther. 2004 Nov;26(11):1758-73. doi: 10.1016/j.clinthera.2004.11.016.

Related trials for Dyslipidemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
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A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
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Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonio Hernández, MD, Phd principal investigator

FISABIO - University Hospital Dr Peset

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Cholesterol Before and After Simvastatin/Ezetimibe Administration (time frame: Baseline, 4 weeks and 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02304926, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.