Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin
2 other identifiers
interventional
250
0 countries
N/A
Brief Summary
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
October 31, 2011
CompletedMay 16, 2024
February 1, 2022
1.8 years
October 29, 2008
September 22, 2011
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Low Density Lipoprotein (LDL)-C
Baseline (Treatment Day 1), Treatment Week 6
Secondary Outcomes (14)
Number of Participants Reaching LDL-C Target Goals of <70 mg/dL
Treatment Week 6
Number of Participants Reaching LDL-C Target Goal <77 mg/dL
Treatment Week 6
Number of Participants Reaching LDL-C Target Goal <100 mg/dL
Treatment Week 6
Percent Change From Baseline in Total Cholesterol
Baseline (Treatment Day 1), Treatment Week 6
Percent Change From Baseline in Triglycerides
Baseline (Treatment Day 1), Treatment Week 6
- +9 more secondary outcomes
Study Arms (2)
ezetimibe/simvastatin 10/40
EXPERIMENTALParticipants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period
atorvastatin 40 mg
ACTIVE COMPARATORParticipants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period
Interventions
ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.
atorvastatin 40 mg tablet once daily for 6 weeks
All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization
Eligibility Criteria
You may qualify if:
- Participants who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation
- Participant meets Adult Treatment Panel (ATP) III High Risk criteria
You may not qualify if:
- Females who are pregnant or breastfeeding
- Participant consumes more than 14 alcoholic beverages per week
- Participant has been treated with an investigational drug within the last 30 days
- Participant has congestive heart failure (New York Heart Association \[NYHA\] Type III or IV)
- Participant has had gastric bypass
- Participant is newly diagnosed with type 1 or 2 diabetes
- Participant is Human Immunodeficiency Virus (HIV) positive
- Participant has a history of drug or alcohol abuse within the last 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Hing Ling PK, Civeira F, Dan AG, Hanson ME, Massaad R, De Tilleghem Cle B, Milardo C, Triscari J. Ezetimibe/simvastatin 10/40 mg versus atorvastatin 40 mg in high cardiovascular risk patients with primary hypercholesterolemia: a randomized, double-blind, active-controlled, multicenter study. Lipids Health Dis. 2012 Jan 31;11:18. doi: 10.1186/1476-511X-11-18.
PMID: 22293030DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
October 29, 2008
First Posted
October 31, 2008
Study Start
November 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
May 16, 2024
Results First Posted
October 31, 2011
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share