- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00817843
The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study (PANACEA)
Multicenter,Double Blind,Randomized, 2-period, Crossover Study to Compare Ezetimibe/Simvastatin (10mg/10 mg) Combination Tablet Versus Simvastatin 80mg Tablet on Postprandial Arterial Endothelial Function in Patients With Metabolic Syndrome
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Amsterdam, Holland, 1005 AZ
- Academic Medical Center
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Hoorn, Holland, 1624 NP
- Vascular Research Center Hoorn
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Utrecht, Holland, 3584 CX
- Department of Vascular Medicine UMC Utrecht
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Waalwijk, Holland, 5141 BM
- TweeSteden Ziekenhuis
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Lleida, Spanien, E-25198
- Hospital Arnau de Vilanova
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
INCLUSION CRITERIA:
Patient has a diagnosis of metabolic syndrome according to the modified 2005 AHA/NHLBI Scientific Statement with at least:
- Abdominal obesity defined as:
*Males: waist circumference >102cm
Females: waist circumference >88cm and two of the following 4 other criteria:
- Triglycerides>150 mg/dL
- HDL Cholesterol
- Males: HDL-C<40 mg/dL
- Females:HDL-C<50 mg/dL - Blood pressure
- Systolic Blood Pressure ≥130 mmHg or
Diastolic Blood Pressure ≥85 mmHg
- Fasting glucose ≥ 100 mg/dL
- Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- Patient is a male or female of 18-79 years of age on the day of signing informed consent.
- Patient is a non-smoker.
- Patient is willing to maintain a stable diet for the duration of the study.
- Patient is a postmenopausal female who is not receiving hormone therapy (including cyclic and non-cyclical hormone replacement therapy or any estrogen antagonist/agonist). Postmenopausal status is defined as (1) no menses for ≥1 year but <3 years and confirmed by FSH levels elevated into the postmenopausal range (as defined by the designated laboratory) or (2) no menses for at least 3 years.
- Patient is naïve to lipid-lowering therapy. Naïve is defined as not being treated with a statin, a fibrate or ezetimibe for 3 months before Visit 1 (Week -2)
- Patient has a baseline fasting LDL-C level of ≥ 100 mg/dL and < 220 mg/dL, and TG level < 400 mg/dL.
EXCLUSION CRITERIA:
- Patient has a BMI > 35.
- Patient has hypersensitivity or intolerance to ezetimibe or simvastatin or any component of these medications, or to latex.
- Patient routinely consumes more than 14 alcoholic drinks per week.
- Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
- Patient has a smoking history > 10 pack-years (1 pack-year = at least 20 cigarettes per day for a year) OR patient who has smoked within 3 months prior to Visit 1 (Week -2).
Patient has exclusionary laboratory values at Visit 1 (Week -2) as listed in the table below:
liver transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) > 1.5 X ULN with no active liver disease Serum glucose > 7.0 mmol/L Creatine kinase(CK)> 2 X ULN Albumin:creatinine ratio > 34 TSH <0.3 mcIU/mL or > 5.0 mcIU/mL
- Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
- It is not possible to obtain a FMD measurement of sufficient quality at screening (Visit 1)
- Patient has congestive heart failure, atherosclerotic vascular disease or acute or chronic coronary heart disease.
13. Patient has had a partial ileal bypass, gastric bypass, gastric banding, celiac disease or other significant intestinal malabsorption.
15. Patient has untreated and uncontrolled hypertension with systolic blood pressure >160 mm Hg or diastolic >100 mm Hg at Visit 1 (Week -2). (Patients with untreated hypertension and with office BP at Visit 1 and Visit 2 averaging 160/100 or less can be enrolled). Patients using blood pressure-lowering medication are excluded.
16. Patient has estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 based on the 4-variable MDRD
17. Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins at Visit 1 (Week -2).
18. Patient has diabetes mellitus defined as a history of diabetes or fasting serum glucose > 126 mg/dL.
For the full exclusion criteria, please check the protocol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: First Simva 80mg then Simvai/Eze10/10mg
First 6 weeks of Simvastatin 80mg, then 6 weeks of Simvastatin/Ezetimibe 10/10mg after 6 weeks of placebo washout
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6 weeks of treatment with simvastatin 80 mg
Andre navne:
6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination
Andre navne:
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Eksperimentel: First Simva/Eze 10/10mg then Simva 80mg
First 6 weeks of Simvastatin/Ezetimibe 10/10mg, then 6 weeks of Simvastatin 80mg after 6 weeks of placebo washout
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6 weeks of treatment with simvastatin 80 mg
Andre navne:
6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Treatment Difference in (Postprandial-Fasting) FMD
Tidsramme: After 6 weeks of treatment
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A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg
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After 6 weeks of treatment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Postprandial Endopat Measurement
Tidsramme: after 6 weeks of treatment (crossover)
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after 6 weeks of treatment (crossover)
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Preprandial Endothelial Function Measured by FMD
Tidsramme: after 6 weeks of treatment (crossover)
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after 6 weeks of treatment (crossover)
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Preprandial Endopat Measurement
Tidsramme: after 6 weeks of treatment (crossover)
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after 6 weeks of treatment (crossover)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdom
- Insulin resistens
- Hyperinsulinisme
- Syndrom
- Metabolisk syndrom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter
- Antikolesteræmiske midler
- Hypolipidæmiske midler
- Lipidregulerende midler
- Hydroxymethylglutaryl-CoA-reduktasehæmmere
- Simvastatin
- Ezetimibe
Andre undersøgelses-id-numre
- Vasc-UMCU-10B
- 2008-003908-61 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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