Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With P… (NCT00650819) | Clinical Trial Compass
CompletedPhase 3
Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED)
240 participantsStarted 2004-06-01
Plain-language summary
This is a multicenter, randomized, double blind; active-controlled parallel groups study enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe, simvastatin, or the combination once daily for 8 weeks to determine the effect on LDL-cholesterol.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
* Subjects must be \>= 18 years and \<= 75 years of age.
* Subjects with Primary Hypercholesterolemia must be finished the Lab test listed below and the results must be available at the time of randomization at Visit 3 (Baseline Visit).
* LDL-C concentration \> 3.64 mmol/L (140mg/dL) to \<= 6.3 mmol/L (250 mg/dL) using the Friedewald calculation
* Total cholesterol (TC) \> 5.2mmol/L (200mg/dL) to \< 12.7mmol/L (500mg/dL)
* Triglyceride concentrations of \<= 3.99 mmol/L (350 mg/dL)
* Liver transaminases (ALT, AST) must be within normal limits, with no active liver disease and CK \< 50% above the upper limit of normal
* Clinical laboratory tests (CBC, blood chemistries, urinalysis) must be within normal limits
* Subjects must report a stable weight history for at least 4 weeks prior to entry into study at Visit 3 (Baseline Visit).
* Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g. medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
* Subjects must be free of any clinically significant diseases other than hyperlipidemia that would interfere with study evaluations.
* Subjects must understand and…
What they're measuring
1
Percent change from baseline in LDL-C concentration.