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Phase 4 Completed N=22 Randomized Triple-blind Treatment

Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)

Hypercholesterolemia · Coronary Arteriosclerosis
Source: ClinicalTrials.gov NCT00319449 ↗
Enrolled (actual)
22
Serious AEs
4.6%
Results posted
May 2011
Primary outcomePrimary: Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg — 148.125; 151.083; 106.000; 108.273 mg/dL

Summary

This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.

Outcome Measures

OutcomeResultp-value
PRIMARY
Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
148.125; 151.083; 106.000; 108.273
SECONDARY
Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)
7; 8
SECONDARY
High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
53.250; 57.667; 52.625; 53.500; 219.125; 226.000

Eligibility Criteria

Inclusion Criteria

  • Participants must have an LDL-C concentration >= 3.3 mmol/L (130 mg/dL) to = 140/90 mmHg or on antihypertensive medication)
  • Low HDL cholesterol ( = 45 years; women >= 55 years)
  • Participant must be currently taking atorvastatin 10 mg daily and by history has taken 80% of daily doses for the 6 weeks prior to participating.
  • Participants must have liver transaminases (ALT, AST) = 30 Kg/m**2.
  • Consume > 14 alcoholic drinks per week.
  • Women who are pregnant or nursing.
  • Congestive heart failure defined by NYHA as Class III or IV.
  • Uncontrolled cardiac arrhythmia.
  • Coronary heart disease (CHD).
  • Unstable or severe peripheral artery disease within 3 months of participating
  • Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 160 mm Hg or diastolic > 100 mm Hg.
  • Type I or Type II diabetes mellitus.
  • Secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to hypothyroidism.
  • Impaired renal function (creatinine > 2.0 mg/dL) or nephrotic syndrome.
  • Known HIV positive.
  • Cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas).
  • History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
  • Participants who are on any of the following concomitant medications:
  • Participants who are on medications that are potent inhibitors of CYP3A4, including cyclosporine, systemic itraconazole, fluconazole, and ketoconazole, erythromycin or clarithromycin, nefazodone, mibefradil, protease inhibitors and large amounts of grapefruit juice (> 1 quart/day).
  • Participants who are on lipid-lowering agents (other atorvastatin): niacin (> 200 mg/day)
  • Participants who are on over the counter lipid lowering agents such as fish oils, garlic and cholestin
  • Participants who are on oral corticosteroids, unless used as replacement therapy for pituitary/adrenal disease and the subject is on a stable regimen for at least 6 weeks.
  • Participants who are currently using psyllium, other fiber-based laxatives, and/or any other OTC therapy known to affect serum lipid levels (phytosterol margarine), and have not been on a stable regimen for at least 5 weeks and who do not agree to remain on this regimen throughout the study.
  • Participant who are currently using orlistat or sibutramine.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00319449). 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.

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