Trial Outcomes & Findings for Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED) (NCT NCT00166504)

NCT ID: NCT00166504

Last Updated: 2024-05-22

Results Overview

LDL-C = low density lipoprotein cholesterol, measured in mg/dl.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 203 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2024-05-22

Participant Flow

After a 4-week diet/wash-out period, patients still at or above drug treatment thresholds established by National Cholesterol Education Program Adult Treatment Panel III Guidelines were randomized. Randomization was stratified according to LDL-C levels obtained 1 week pre-randomization: ≥130 to <160 mg/dL; ≥160 to <190 mg/dL; ≥190 mg/dL.

Participant milestones

Measure	Vytorin Ezetimibe 10 mg/Simvastatin 20 mg	Atorvastatin Atorvastatin 10 mg
Overall Study STARTED	108	95
Overall Study COMPLETED	103	91
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	Vytorin Ezetimibe 10 mg/Simvastatin 20 mg	Atorvastatin Atorvastatin 10 mg
Overall Study Adverse Event	3	3
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

Baseline characteristics by cohort

Measure	Vytorin n=108 Participants Ezetimibe 10 mg/Simvastatin 20 mg	Atorvastatin n=95 Participants Atorvastatin 10 mg	Total n=203 Participants Total of all reporting groups
Age, Continuous	58.4 years STANDARD_DEVIATION 10.7 • n=5 Participants	58.7 years STANDARD_DEVIATION 8.7 • n=7 Participants	58.5 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	56 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	39 Participants n=7 Participants	90 Participants n=5 Participants
Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata <130 mg/dl	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata >=130 to <160 mg/dl	45 Participants n=5 Participants	32 Participants n=7 Participants	77 Participants n=5 Participants
Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata >=160 to <190 mg/dl	41 Participants n=5 Participants	43 Participants n=7 Participants	84 Participants n=5 Participants
Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata >=190 mg/dl	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Body Mass Index	25.3 kg/m2 STANDARD_DEVIATION 2.9 • n=5 Participants	25 kg/m2 STANDARD_DEVIATION 2.8 • n=7 Participants	25.2 kg/m2 STANDARD_DEVIATION 2.8 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Included patients with LDL-C data at both baseline and at the 6-week post-randomization time point.

LDL-C = low density lipoprotein cholesterol, measured in mg/dl.

Outcome measures

Measure	Vytorin n=105 Participants Ezetimibe 10 mg/Simvastatin 20 mg	Atorvastatin n=93 Participants Atorvastatin 10 mg
LDL-C Lowering Efficacy	-51 Percent Change from Baseline Standard Deviation 14.7	-41 Percent Change from Baseline Standard Deviation 16

Adverse Events

Vytorin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Atorvastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER