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Completed

NCT Number: NCT03882892

Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)

The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.

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Key information

Conditions

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

Age range

18 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This study is a long-term extension study of the protocol P00692 parent study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Has successfully completed the 12-week double-blind, efficacy and safety parent study (P00692).
  • If female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose.
  • If postmenopausal female receiving hormone therapy, a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen must be maintained during the study period.
  • Is willing to continue to follow their prescribed National Cholesterol Education Program (NCEP) Step 1 diet for the duration of the study.

Exclusion criteria

  • Has discontinued from the parent study (P00692) prior to study completion.
  • Is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation.
  • Is a pregnant or lactating female.
  • Is human immunodeficiency virus (HIV) positive.

Treatment and study plan

ezetimibe

Drug

Ezetimibe 10 mg tablets

Other names: SCH 58235

Atovastatin

Drug

Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg

Placebo

Drug

Placebo tablets matched to ezetimibe

Primary outcomes

  1. Percentage of Participants Experiencing ≥1 Adverse Event (AE)

    Time frame: Up to 12 months

  2. Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)

    Time frame: Up to 12 months

Secondary outcomes

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

    Time frame: Baseline and 1.5, 3, 6, 9, and 12 months

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

    Time frame: Baseline and 1.5, 3, 6, 9, and 12 months

  3. Mean Percent Change from Baseline in Triglyceride Levels

    Time frame: Baseline and 1.5, 3, 6, 9, and 12 months

  4. Mean Percent Change from Baseline in Total Cholesterol (TC)

    Time frame: Baseline and 1.5, 3, 6, 9, and 12 months

  5. Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline and 1.5, 3, 6, 9, and 12 months

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Long-Term, Safety and Tolerability Study of SCH 58235 or Placebo in Addition to Atorvastatin in Subjects With Primary Hypercholesterolemia

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Mar 20, 2019
Registry last updated
May 10, 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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