Trial Outcomes & Findings for Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol (NCT NCT00762164)

NCT ID: NCT00762164

Last Updated: 2013-07-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 34 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2013-07-03

Participant Flow

Thirty-four patients were randomized from August 2007 through October 2008. Patients were recruited from our cardiology and lipid clinics.

There was no washout phase during the study. No patients were excluded after enrollment.

Participant milestones

Measure	1Vytorin 10/80 Divided Into 4 Vytorin 10/80 divided into 4	Simvastatin Simvastatin 20 milligrams
Overall Study STARTED	17	17
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	1Vytorin 10/80 Divided Into 4 Vytorin 10/80 divided into 4	Simvastatin Simvastatin 20 milligrams
Overall Study Lost to Follow-up	1	1
Overall Study Discontinued medication	2	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol

Baseline characteristics by cohort

Measure	1Vytorin 10/80 Divided Into 4 n=17 Participants Vytorin 10/80 divided into 4	Simvastatin n=17 Participants Simvastatin 20 milligrams	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age Continuous	55.3 years STANDARD_DEVIATION 12.6 • n=5 Participants	62.7 years STANDARD_DEVIATION 7.8 • n=7 Participants	59.1 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	1Vytorin 10/80 Divided Into 4 n=14 Participants Vytorin 10/80 divided into 4	Simvastatin n=15 Participants Simvastatin 20 milligrams
LDL Cholesterol	-44.7 % change in LDL cholesterol Standard Deviation 19.0	-27.1 % change in LDL cholesterol Standard Deviation 22.4

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	1Vytorin 10/80 Divided Into 4 n=14 Participants Vytorin 10/80 divided into 4	Simvastatin n=15 Participants Simvastatin 20 milligrams
Total Cholesterol	-34.2 % change in total cholesterol Standard Deviation 13.0	-19.9 % change in total cholesterol Standard Deviation 14.6

Adverse Events

1Vytorin 10/80 Divided Into 4

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Simvastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	1Vytorin 10/80 Divided Into 4 n=17 participants at risk Vytorin 10/80 divided into 4	Simvastatin n=16 participants at risk Simvastatin 20 milligrams
Musculoskeletal and connective tissue disorders Muscle pain-Myalgia	11.8% 2/17 • Number of events 2 • 6 weeks One patient never received the simvastatin in the simvastatin arm.	0.00% 0/16 • 6 weeks One patient never received the simvastatin in the simvastatin arm.

Additional Information

Dr. Lawrence Baruch

Bronx VA Medical Center

Phone: 718-584-9000

Email: lawrence.baruch@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place