Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED)

NCT00650819 | Completed Phase 3

• 1 other identifier: P03757
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in LDL-C concentration.

  8 weeks

Secondary Outcomes (1)

• Percent change from baseline in total cholesterol, triglycerides, and HDL-C.

  8 weeks

Study Arms (3)

Ezetimibe + Simvastatin

EXPERIMENTAL

Drug: Ezetimibe + Simvastatin

Simvastatin

ACTIVE COMPARATOR

Drug: Simvastatin

Ezetimibe

ACTIVE COMPARATOR

Drug: Ezetimibe

Interventions

Ezetimibe + Simvastatin DRUG

ezetimibe 10 mg plus simvastatin 20 mg once daily for 8 weeks

Also known as: SCH 58235

Ezetimibe + Simvastatin

Simvastatin DRUG

simvastatin 20 mg plus ezetimibe placebo once daily for 8 weeks

Simvastatin

Ezetimibe DRUG

Ezetimibe 10 mg plus simvastatin placebo once daily for 8 weeks

Also known as: SCH 58235

Ezetimibe

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 be able to adhere to the dosing and visit schedules, and must agree to remain on a cholesterol-lowering diet for the duration of the study.

You may not qualify if:

• Subjects whose body mass index (BMI = weight \[kg\]/height2 \[m\]) is \>= 30 Kg/m\^2 at Visit 3 (Baseline Visit).
• Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.
• Subjects who consume \> 14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits).
• Any condition or situation, which in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
• Women who are pregnant or nursing
• Subjects who have not observed the designated washout periods for any of the prohibited medications outlined in protocol
• Congestive heart failure defined by NYHA as Class III or IV.
• Uncontrolled cardiac arrhythmia.
• Myocardial infarction, coronary bypass surgery or angioplasty within 6 months of study entry.
• Unstable or severe peripheral artery disease within 3 months of study entry.
• Unstable angina pectoris within 6 months of study entry.
• Uncontrolled hypertension (treated or untreated) with systolic blood pressure \> 160 mm Hg or diastolic \> 100 mm Hg of study entry.
• Uncontrolled (as determined by HbA1c \> 7 %) or newly diagnosed (within 1month of study entry) diabetes mellitus.
• Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, i.e., secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to hypothyroidism (TSH above upper limit of normal). Subjects with a history of hypothyroidism who are on a stable therapy of thyroid hormone replacement for at least 6 weeks are eligible for enrollment if TSH levels are within normal limits before enrollment.
• Known Impaired renal function (plasma creatinine \> 2.0 mg/dL), or nephrotic syndrome of study entry.

Sponsors & Collaborators

• Organon and Co: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe, Simvastatin Drug Combination; Ezetimibe; Simvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: June 1, 2004
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: August 15, 2024

Record last verified: 2022-02