Back to resultsLong-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ezetimibe
Atovastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo + Atorvastatin
Ezetimibe + Atorvastatin
Arm Description
Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)
Secondary Outcome Measures
Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Mean Percent Change from Baseline in Triglyceride Levels
Mean Percent Change from Baseline in Total Cholesterol (TC)
Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03882892
Brief Title
Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)
Official Title
Long-Term, Safety and Tolerability Study of SCH 58235 or Placebo in Addition to Atorvastatin in Subjects With Primary Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2001 (Actual)
Primary Completion Date
August 8, 2002 (Actual)
Study Completion Date
August 8, 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study is a long-term extension study of the protocol P00692 parent study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo + Atorvastatin
Arm Type
Placebo Comparator
Arm Description
Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study.
Arm Title
Ezetimibe + Atorvastatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
SCH 58235
Intervention Description
Ezetimibe 10 mg tablets
Intervention Type
Drug
Intervention Name(s)
Atovastatin
Intervention Description
Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets matched to ezetimibe
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
Time Frame
Up to 12 months
Title
Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time Frame
Baseline and 1.5, 3, 6, 9, and 12 months
Title
Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Time Frame
Baseline and 1.5, 3, 6, 9, and 12 months
Title
Mean Percent Change from Baseline in Triglyceride Levels
Time Frame
Baseline and 1.5, 3, 6, 9, and 12 months
Title
Mean Percent Change from Baseline in Total Cholesterol (TC)
Time Frame
Baseline and 1.5, 3, 6, 9, and 12 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
15311720
Citation
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.
Results Reference
result
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Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)
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