Phase 4
Completed N=100
The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study
Source: ClinicalTrials.gov NCT00817843 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Jan 2013
Primary outcomePrimary: Treatment Difference in (Postprandial-Fasting) FMD — -0.34; -0.43 % (change FMD) — p=0.766
Summary
The purpose of this study is to investigate whether low-dose simvastatin in combination with ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the function of the endothelium after an oral fat load in patients with metabolic syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Difference in (Postprandial-Fasting) FMD |
-0.34; -0.43 | 0.766 |
| SECONDARY Postprandial Endopat Measurement |
— | — |
| SECONDARY Preprandial Endothelial Function Measured by FMD |
— | — |
| SECONDARY Preprandial Endopat Measurement |
— | — |
Eligibility Criteria
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 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 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.
- Patient has had a partial ileal bypass, gastric bypass, gastric banding, celiac disease or other significant intestinal malabsorption.
- 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.
- Patient has estimated glomerular filtration rate (eGFR) 126 mg/dL.
For the full exclusion criteria, please check the protocol
Data sourced from ClinicalTrials.gov (NCT00817843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.