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Completed

NCT Number: NCT00271817

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

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

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Key information

Conditions

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

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: ezetimibe/simvastatin + niacin (ER)

Drug

ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks

Comparator: Placebo to ezetimibe/simvastatin

Drug

ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.

Comparator: niacin (ER) tablet

Drug

niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks

Comparator: ezetimibe (+) simvastatin

Drug

ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.

Comparator: Placebo to Niacin (ER)

Drug

Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.

Comparator: ezetimibe/simvastatin and niacin (ER)

Drug

ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks

Comparator: ezetimibe and simvastatin

Drug

ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks

Primary outcomes

  1. Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

    Time frame: Baseline and 24 Weeks

    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

  2. Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

    Time frame: Baseline and 24 weeks

    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 outcomes

  1. Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

    Time frame: Baseline and 24 weeks

    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

  2. Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)

    Time frame: Baseline and 24 weeks

    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

  3. Percent Change From Baseline in Triglycerides (TG)

    Time frame: baseline and 24 Weeks

    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

  4. Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)

    Time frame: Baseline and 64 weeks

    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

  5. Percent Change From Baseline in Triglycerides (TG)

    Time frame: Baseline and 64 weeks

    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

  6. Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

    Time frame: Baseline and 64 weeks

    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

  7. Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

    Time frame: Baseline and 64 weeks

    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

  8. Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

    Time frame: Baseline and 24 weeks

    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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 4, 2006
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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