To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00271817
First received: January 3, 2006
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.


Condition Intervention Phase
Hypercholesterolemia
Drug: Comparator: ezetimibe/simvastatin + niacin (ER)
Drug: Comparator: Placebo to ezetimibe/simvastatin
Drug: Comparator: niacin (ER) tablet
Drug: Comparator: ezetimibe (+) simvastatin
Drug: Comparator: Placebo to Niacin (ER)
Drug: Comparator: ezetimibe/simvastatin and niacin (ER)
Drug: Comparator: ezetimibe and simvastatin
Drug: Comparator: Placebo to niacin (ER)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia

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) [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline

  • Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline


Secondary Outcome Measures:
  • Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline

  • Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline

  • Percent Change From Baseline in Triglycerides (TG) [ Time Frame: baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline

  • Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline

  • Percent Change From Baseline in Triglycerides (TG) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline

  • Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline

  • Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline and 64 weeks ] [ Designated as safety issue: No ]
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline

  • Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline


Enrollment: 1220
Study Start Date: December 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part 1 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
Drug: Comparator: ezetimibe/simvastatin + niacin (ER)
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
Active Comparator: Part 1 -Arm 2
ezetimibe/simvastatin
Drug: Comparator: ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.
Drug: Comparator: Placebo to Niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.
Active Comparator: Part 1 - Arm 3
Niacin (ER)
Drug: Comparator: Placebo to ezetimibe/simvastatin
ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.
Drug: Comparator: niacin (ER) tablet
niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
Active Comparator: Part 2 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
Drug: Comparator: ezetimibe/simvastatin and niacin (ER)
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks
Placebo Comparator: Part 2 - Arm 2
ezetimibe/simvastatin combination tablet + niacin (Pbo)
Drug: Comparator: ezetimibe and simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
Drug: Comparator: Placebo to niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks

  Eligibility

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

Inclusion Criteria:

  • Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
  • Patient willing to be on a low-cholesterol diet

Exclusion Criteria:

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
  • Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
  • Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271817

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00271817     History of Changes
Other Study ID Numbers: 0653A-091, 2005_091
Study First Received: January 3, 2006
Results First Received: February 13, 2009
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Niacin
Niacinamide
Nicotinic Acids
Simvastatin
Anticholesteremic Agents
Antimetabolites
Cardiovascular Agents
Enzyme Inhibitors
Growth Substances
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 22, 2014