Trial Outcomes & Findings for Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355) (NCT NCT00652327)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

83 participants

Primary outcome timeframe

Assessed at the end of 8 weeks of treatment (from baseline to endpoint)

Results posted on

2022-02-09

Participant Flow

A total of 202 potential participants signed informed consent during a screening visit. Of these, 119 did not meet protocol eligibility requirements. The remainder, 83, received randomized treatment assignment.

Participant milestones

Participant milestones
Measure	Ezetimibe + Statin Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks	Double Statin Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
Overall Study STARTED	42	41
Overall Study COMPLETED	42	36
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Ezetimibe + Statin Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks	Double Statin Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ezetimibe + Statin n=42 Participants Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks	Double Statin n=41 Participants Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks	Total n=83 Participants Total of all reporting groups
Age, Customized <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Between 18 and 83 years	42 Participants n=5 Participants	41 Participants n=7 Participants	83 Participants n=5 Participants
Age, Customized >=83 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment Taiwan, Province Of China	42 Participants n=5 Participants	41 Participants n=7 Participants	83 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at the end of 8 weeks of treatment (from baseline to endpoint)

Population: The population analyzed (intent-to-treat \[ITT\]) included all participants who had a post-randomization LDL-C laboratory evaluation. As such, 20 of the 83 participants who received treatment assignment were excluded from the ITT. The 5 participants who discontinued were included in the ITT as each had a post-randomization LDL-C lab evaluation.

Outcome measures

Outcome measures
Measure	Ezetimibe + Statin n=29 Participants Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks	Double Statin n=34 Participants Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
Percentage Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline at Study Endpoint, After 8 Weeks of Treatment	-26.56 Percentage change Standard Deviation 19.78	-9.7 Percentage change Standard Deviation 21.07

Adverse Events

Ezetimibe + Statin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Double Statin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ezetimibe + Statin n=42 participants at risk Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks	Double Statin n=41 participants at risk Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
Infections and infestations upper respiratory tract infection	2.4% 1/42 • Number of events 1	0.00% 0/41

Other adverse events

Other adverse events
Measure	Ezetimibe + Statin n=42 participants at risk Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks	Double Statin n=41 participants at risk Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
Ear and labyrinth disorders vertigo	0.00% 0/42	7.3% 3/41 • Number of events 3

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60