- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Amsterdam, Netherlands, 1005 AZ
- Academic Medical Center
-
Hoorn, Netherlands, 1624 NP
- Vascular Research Center Hoorn
-
Utrecht, Netherlands, 3584 CX
- Department of Vascular Medicine UMC Utrecht
-
Waalwijk, Netherlands, 5141 BM
- TweeSteden Ziekenhuis
-
-
-
-
-
Lleida, Spain, E-25198
- Hospital Arnau de Vilanova
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
6 weeks of treatment with simvastatin 80 mg
Other Names:
6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination
Other Names:
|
Experimental: 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
|
6 weeks of treatment with simvastatin 80 mg
Other Names:
6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Difference in (Postprandial-Fasting) FMD
Time Frame: After 6 weeks of treatment
|
A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg
|
After 6 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postprandial Endopat Measurement
Time Frame: after 6 weeks of treatment (crossover)
|
after 6 weeks of treatment (crossover)
|
Preprandial Endothelial Function Measured by FMD
Time Frame: after 6 weeks of treatment (crossover)
|
after 6 weeks of treatment (crossover)
|
Preprandial Endopat Measurement
Time Frame: after 6 weeks of treatment (crossover)
|
after 6 weeks of treatment (crossover)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Disease
- Insulin Resistance
- Hyperinsulinism
- Syndrome
- Metabolic Syndrome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
- Ezetimibe
Other Study ID Numbers
- Vasc-UMCU-10B
- 2008-003908-61 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metabolic Syndrome
-
Universidad de los Andes, ChileCompleted
-
Taipei Medical University WanFang HospitalUnknownMetabolic Cardiovascular SyndromeTaiwan
-
Mayo ClinicCompleted
-
SanofiBristol-Myers SquibbCompletedMetabolic Syndrome xUnited States
-
University of HohenheimGerman Federal Ministry of Education and ResearchCompleted
-
The Catholic University of KoreaCompletedMetabolic Syndrome X | Metabolic Cardiovascular Syndrome | Insulin Resistance Syndrome X | Dysmetabolic Syndrome XKorea, Republic of
-
Charite University, Berlin, GermanyRecruitingMetabolic Syndrome, Protection AgainstGermany
-
Wageningen University and ResearchPhilips Healthcare; TNO; Friesland Campina; Albert Heijn; Menzis; Smart with food; Vi... and other collaboratorsCompletedMetabolic Syndrome, Protection AgainstNetherlands
-
Cairo UniversityCompletedMetabolic Syndrome in WomenEgypt
-
Andalas UniversityHasanuddin University; Universitas Sumatera UtaraCompletedMetabolic Syndrome, Protection AgainstIndonesia
Clinical Trials on Simvastatin
-
University of CopenhagenCompletedCardiovascular Disease | Diabetes MellitusDenmark
-
Organon and CoCompletedMyocardial Infarction | Hypercholesterolemia
-
University of Sao PauloCompletedCoronary Heart Disease
-
University of Maryland, BaltimoreMerck Sharp & Dohme LLCCompletedMetabolic SyndromeUnited States
-
Peking Union Medical College HospitalUnknownAtherosclerosisChina
-
Organon and CoCompletedHypercholesterolemia
-
Hue University of Medicine and PharmacyUniversità degli Studi di SassariUnknownChronic Kidney Diseases | HypercholesterolemiaVietnam
-
Federal State Budgetary Scientific Institution,...Completed
-
Organon and CoCompleted
-
Organon and CoSchering-PloughCompletedCoronary Disease | Hypercholesterolemia