A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Ezetimibe/atorvastatin; Drug: Atorvastatin; Drug: Placebo to atorvastatin; Drug: Ezetimibe; Drug: Placebo to ezetimibe/atorvastatin; Drug: Placebo to ezetimibe

• Registration Number: NCT01370590
• Lead Sponsor: Organon and Co

Brief Summary

The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/20 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 20 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-10
• Study Start: 2011-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-05-17
• Results First Submitted QC: 2013-05-17
• Results First Posted: 2013-08-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ezetimibe/atorvastatin combination	Ezetimibe/atorvastatin	Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including ezetimibe/atorvastatin 10 mg/20 mg, placebo to ezetimibe, and placebo to atorvastatin.
Ezetimibe and atorvastatin	Placebo to ezetimibe/atorvastatin	Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including 10 mg ezetimibe, 20 mg atorvastatin, and placebo to ezetimibe/atorvastatin.
Ezetimibe/atorvastatin combination	Placebo to atorvastatin	Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including ezetimibe/atorvastatin 10 mg/20 mg, placebo to ezetimibe, and placebo to atorvastatin.
Ezetimibe/atorvastatin combination	Placebo to ezetimibe	Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including ezetimibe/atorvastatin 10 mg/20 mg, placebo to ezetimibe, and placebo to atorvastatin.
Ezetimibe and atorvastatin	Atorvastatin	Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including 10 mg ezetimibe, 20 mg atorvastatin, and placebo to ezetimibe/atorvastatin.
Ezetimibe and atorvastatin	Ezetimibe	Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including 10 mg ezetimibe, 20 mg atorvastatin, and placebo to ezetimibe/atorvastatin.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment	Baseline and Week 6	Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment	Baseline and Week 6	Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.
Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment	Baseline and Week 6	Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment	Baseline and Week 6	Non-HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment	Baseline and Week 6	Serum HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.
Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment	Baseline and Week 6	Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.