Trial record 2 of 54 for:    mk-0653c

A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01370590
First received: June 8, 2011
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/20 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 20 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.


Condition Intervention Phase
Hypercholesterolemia
Drug: Atorvastatin
Drug: Ezetimibe
Drug: Ezetimibe/atorvastatin
Drug: Placebo to atorvastatin
Drug: Placebo to ezetimibe
Drug: Placebo to ezetimibe/atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Active-Controlled, Multicenter, Crossover Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin 10 mg/20 mg Fixed-Dose Combination Tablet Compared to Co-administration of Marketed Ezetimibe 10 mg and Atorvastatin 20 mg in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.


Secondary Outcome Measures:
  • Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.

  • Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Serum HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.

  • Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Non-HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.

  • Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.

  • Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.


Enrollment: 406
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ezetimibe and atorvastatin
Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including 10 mg ezetimibe, 20 mg atorvastatin, and placebo to ezetimibe/atorvastatin.
Drug: Atorvastatin
20 mg tablet administered orally once daily
Other Name: Lipitor®
Drug: Ezetimibe
10 mg tablet administered orally once daily
Other Name: Zetia®
Drug: Placebo to ezetimibe/atorvastatin
Administered orally once daily
Experimental: Ezetimibe/atorvastatin combination
Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including ezetimibe/atorvastatin 10 mg/20 mg, placebo to ezetimibe, and placebo to atorvastatin.
Drug: Ezetimibe/atorvastatin
Ezetimibe/atorvastatin 10 mg/20 mg combination tablet administered orally once daily
Other Names:
  • Liptruzet®
  • MK-0653C
Drug: Placebo to atorvastatin
Administered orally once daily
Drug: Placebo to ezetimibe
Administered orally once daily

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • At low, moderate, or moderately high cardiovascular risk (according to National Cholesterol Education Program adult treatment panel III [NCEP ATP III] guidelines) and either statin-naïve with LDL-C ≥130 mg/dL for low risk or ≥100 mg/dL for moderate or moderately high risk OR on an allowable statin with on-therapy LDL-C ≥100 mg/dL in acceptable range and can safely discontinue and switch to study medication.
  • Is willing to maintain a cholesterol-lowering diet throughout the study.
  • Female of reproductive potential agrees to remain abstinent or to use (or have their partner use) 2 acceptable methods of birth control throughout the study.
  • Female receiving non-cyclical hormone therapy, if maintained on a stable dose and regimen for at least 8 weeks prior to the study and if willing to continue the same regimen throughout the study.
  • Off-therapy LDL-C levels are: for low risk patients, ≥130 mg/dL and ≤300 mg/dL; for moderate risk patients, ≥100 mg/dL and ≤300 mg/dL; for moderately high risk patients, ≥100 mg/dL and ≤275 mg/dL.
  • Has liver transaminases ≤2 X upper limit of normal (ULN) with no active liver disease.
  • Has creatine kinase (CK) levels ≤3 X ULN.
  • Has triglyceride (TG) concentrations ≤400 mg/dL.

Exclusion criteria:

  • Hypersensitivity or intolerance to ezetimibe, atorvastatin, the ezetimibe/atorvastatin combination tablet, or any component of these medications, or a history of myopathy or rhabdomyolysis with ezetimibe or any statin.
  • Routinely consumes more than 2 alcoholic drinks per day (average >14 alcoholic drinks per week).
  • Is pregnant or lactating.
  • Has been treated with any other investigational drug within 30 days of the study.
  • Has any condition or situation that might pose a risk to the participant or interfere with participation in the study.
  • Is high risk (according to NCEP ATP III guidelines), including but not limited to one or more of the following: diabetes mellitus (Type I or II), myocardial infarction, coronary artery bypass surgery, angioplasty, stable or unstable angina.
  • Has any of the following medical conditions: congestive heart failure; uncontrolled cardiac arrhythmias or recent significant changes in electrocardiogram (ECG); homozygous familial hypercholesterolemia or has undergone LDL apheresis; partial ileal bypass, gastric bypass, or other significant intestinal malabsorption; uncontrolled hypertension; kidney disease; disease known to influence serum lipids or lipoproteins; hematologic, digestive, or central nervous systems disorder; known to be human immunodeficiency virus (HIV) positive; history of malignancy ≤5 years prior to the study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer; mental instability; drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
  • Taking prohibited medications/foods including: systemic azole antifungals (e.g., fluconazole, ketoconazole), erythromycin or clarithromycin, and cyclosporine; ritonavir and saquinavir or lopinavir; >5 cups of grapefruit juice per day; combination therapies of ezetimibe + simvastatin (10/80 mg), ezetimibe + atorvastatin (10/40 mg or 10/80 mg), ezetimibe + rosuvastatin (10/10 mg, 10/20 mg, or 10/40 mg), ezetimibe + pitavastatin (10/4 mg); non-statin lipid-lowering agents including fish oils containing >900 mg/day of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA), red yeast extract, Cholestin™, bile acid sequestrants, other cholesterol-lowering agents, niacin (>200 mg/day), or fibrates; systemic corticosteroids; psyllium, other fiber-based laxatives, phytosterol margarines, and/or over the counter (OTC) therapies known to affect serum lipid levels; orlistat or other anti-obesity medications and not maintained on a stable dose; any cyclical hormones; warfarin treatment without a stable dose or a stable International Normalized Ratio (INR).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01370590     History of Changes
Other Study ID Numbers: 0653C-185
Study First Received: June 8, 2011
Results First Received: May 17, 2013
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014