Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category
Exclusion Criteria:
- A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
- Patient is likely to be greater than 20% noncompliant in taking study medications
- Patients with chronic medical conditions
- Patients with unstable doses of medications
- Pregnant or lactating women, women intending to become pregnant
- Patient is currently receiving prescription therapy with statins or other lipid-altering medications
- Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 1
Arm 1: drug + comparator + Placebo
|
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
Andra namn:
Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
Andra namn:
Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. |
|
Övrig: 2
Arm 2: drug + comparator + Placebo
|
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
Andra namn:
Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
Andra namn:
Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. |
|
Övrig: 3
Arm 3: drug + comparator + Placebo
|
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
Andra namn:
Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
Andra namn:
Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. |
|
Övrig: 4
Arm 4: drug + comparator + Placebo
|
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
Andra namn:
Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
Andra namn:
Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. |
|
Övrig: 5
Arm 5: drug + comparator + Placebo
|
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
Andra namn:
Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
Andra namn:
Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
Tidsram: Baseline and 6 weeks
|
Baseline and 6 weeks
|
|
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
|
Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6
Tidsram: Baseline and 6 Weeks
|
Baseline and 6 Weeks
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- Rosen JB, Ballantyne CM, Hsueh WA, Lin J, Shah AK, Lowe RS, Tershakovec AM. Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk. Lipids Health Dis. 2015 Sep 4;14:103. doi: 10.1186/s12944-015-0075-5.
- Robinson JG, Ballantyne CM, Hsueh W, Rosen J, Lin J, Shah A, Lowe RS, Hanson ME, Tershakovec AM. Achievement of specified low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol apolipoprotein B, and high-sensitivity C-reactive protein levels with ezetimibe/simvastatin or atorvastatin in metabolic syndrome patients with and without atherosclerotic vascular disease (from the VYMET study). J Clin Lipidol. 2011 Nov-Dec;5(6):474-82. doi: 10.1016/j.jacl.2011.06.004. Epub 2011 Jun 15.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Störningar i glukosmetabolism
- Metaboliska sjukdomar
- Sjukdom
- Insulinresistens
- Hyperinsulinism
- Lipidmetabolismstörningar
- Hyperlipidemier
- Dyslipidemier
- Syndrom
- Metaboliskt syndrom
- Hyperkolesterolemi
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antimetaboliter
- Antikolesteremiska medel
- Hypolipidemiska medel
- Lipidreglerande medel
- Hydroximetylglutaryl-CoA-reduktashämmare
- Kalciumreglerande hormoner och medel
- Atorvastatin
- Kalcium
- Simvastatin
- Ezetimib
Andra studie-ID-nummer
- 0653A-107
- 2006_527
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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