Status:

COMPLETED

Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)

Lead Sponsor:

Organon and Co

Conditions:

Hypercholesterolemia

Eligibility:

All Genders

18-79 years

Phase:

PHASE3

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-de...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT00782184

Start Date

November 1 2008

End Date

September 1 2010

Last Update

May 16 2024

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