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

NCT03882892 | Completed Phase 3 FDA Drug

• 2 other identifiers: P02154MK-0653-017
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

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

  Up to 12 months

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

  Up to 12 months

Secondary Outcomes (5)

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

  Baseline and 1.5, 3, 6, 9, and 12 months

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

  Baseline and 1.5, 3, 6, 9, and 12 months

• Mean Percent Change from Baseline in Triglyceride Levels

  Baseline and 1.5, 3, 6, 9, and 12 months

• Mean Percent Change from Baseline in Total Cholesterol (TC)

  Baseline and 1.5, 3, 6, 9, and 12 months

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

  Baseline and 1.5, 3, 6, 9, and 12 months

Study Arms (2)

Placebo + Atorvastatin

PLACEBO COMPARATOR

Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study.

Drug: Atovastatin; Drug: Placebo

Ezetimibe + Atorvastatin

EXPERIMENTAL

Participants who received ezetimibe + atorvastatin, or atorvastatin alone, in the parent study (P00692) receive ezetimibe (blinded) + atorvastatin (10 mg/day; open-label) in this study.

Drug: Ezetimibe; Drug: Atovastatin

Interventions

Ezetimibe DRUG

Ezetimibe 10 mg tablets

Also known as: SCH 58235

Ezetimibe + Atorvastatin

Atovastatin DRUG

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

Ezetimibe + Atorvastatin; Placebo + Atorvastatin

Placebo DRUG

Placebo tablets matched to ezetimibe

Placebo + Atorvastatin

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Ballantyne CM, Lipka LJ, Sager PT, Strony J, Alizadeh J, Suresh R, Veltri EP. Long-term safety and tolerability profile of ezetimibe and atorvastatin coadministration therapy in patients with primary hypercholesterolaemia. Int J Clin Pract. 2004 Jul;58(7):653-8. doi: 10.1111/j.1368-5031.2004.00278.x.

  PMID: 15311720 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 20, 2019
• Study Start: February 2, 2001
• Primary Completion: August 8, 2002
• Study Completion: August 8, 2002
• Last Updated: May 10, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share