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

• Sponsor: Bronx VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00762164
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: Vytorin; Drug: Simvastatin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Efficacy of a Vytorin 10/80 Tablet Split Into 4 (Estimated Dose Ezetimibe 2.5 + Simvastatin 20) Versus Simvastatin 20 Milligrams on LDL Cholesterol
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1Vytorin 10/80 divided into 4 Vytorin 10/80 divided into 4	Drug: Vytorin; Vytorin 10/80 split into 4
Active Comparator: Simvastatin Simvastatin 20 milligrams	Drug: Simvastatin; Simvastatin 20 milligrams

Outcome Measures

Primary Outcome Measures

1. LDL Cholesterol [6 weeks]

Secondary Outcome Measures

1. Total Cholesterol [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects with an LDL-cholesterol greater than 100 mg/dL

• Patients willing and able to provide signed informed consent

Exclusion Criteria:

• Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)

• Patients intolerant of statins

• Patients receiving ezetimibe

• Patients intolerant of ezetimibe

• Patients receiving a niacin preparation

• Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months

• Cancer undergoing active treatment

• Creatinine clearance < 50 ml/minute

• Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level

• Participation in any clinical study within the last 30 days

• Drug addition or alcohol abuse within the past 6 months

• Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months

• Active use of macrolide antibiotics or verapamil

• Consumption of grapefruit juice on a daily basis

• Patients unwilling or unable to provide informed consent

• Patients with poor compliance

• Women of childbearing potential

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bronx VA Medical Center	Bronx	New York	United States	10468

Sponsors and Collaborators

• Bronx VA Medical Center

Investigators

• Principal Investigator: Lawrence Baruch, MD, Bronx VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawrence Baruch, Staff Physician, Bronx VA Medical Center
• ClinicalTrials.gov Identifier: NCT00762164
• Other Study ID Numbers: VA---19-07-01
• First Posted: Sep 30, 2008
• Last Update Posted: Jul 3, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Lawrence Baruch, Staff Physician, Bronx VA Medical Center: Hypercholesterolemia; Statins; Ezetimibe
• Additional relevant MeSH terms: Hypercholesterolemia; Simvastatin; Ezetimibe, Simvastatin Drug Combination

Study Results

Participant Flow

Recruitment Details	Thirty-four patients were randomized from August 2007 through October 2008. Patients were recruited from our cardiology and lipid clinics.
Pre-assignment Detail	There was no washout phase during the study. No patients were excluded after enrollment.

Arm/Group Title	1Vytorin 10/80 Divided Into 4	Simvastatin
Arm/Group Description	Vytorin 10/80 divided into 4	Simvastatin 20 milligrams
Period Title: Overall Study
STARTED	17	17
COMPLETED	14	15
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	1Vytorin 10/80 Divided Into 4	Simvastatin	Total
Arm/Group Description	Vytorin 10/80 divided into 4	Simvastatin 20 milligrams	Total of all reporting groups
Overall Participants	17	17	34
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 76.5%	11 64.7%	24 70.6%
>=65 years	4 23.5%	6 35.3%	10 29.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.3 (12.6)	62.7 (7.8)	59.1 (10.8)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	17 100%	17 100%	34 100%
Region of Enrollment (participants) [Number]
United States	17 100%	17 100%	34 100%

Outcome Measures

1. Primary Outcome

Title	LDL Cholesterol
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1Vytorin 10/80 Divided Into 4	Simvastatin
Arm/Group Description	Vytorin 10/80 divided into 4	Simvastatin 20 milligrams
Measure Participants	14	15
Mean (Standard Deviation) [% change in LDL cholesterol]	-44.7 (19.0)	-27.1 (22.4)

2. Secondary Outcome

Title	Total Cholesterol
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1Vytorin 10/80 Divided Into 4	Simvastatin
Arm/Group Description	Vytorin 10/80 divided into 4	Simvastatin 20 milligrams
Measure Participants	14	15
Mean (Standard Deviation) [% change in total cholesterol]	-34.2 (13.0)	-19.9 (14.6)

Adverse Events

Time Frame	6 weeks
Adverse Event Reporting Description	One patient never received the simvastatin in the simvastatin arm.
Arm/Group Title	1Vytorin 10/80 Divided Into 4		Simvastatin
Arm/Group Description	Vytorin 10/80 divided into 4		Simvastatin 20 milligrams
All Cause Mortality
	1Vytorin 10/80 Divided Into 4		Simvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1Vytorin 10/80 Divided Into 4		Simvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	1Vytorin 10/80 Divided Into 4		Simvastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/17 (11.8%)		0/16 (0%)
Musculoskeletal and connective tissue disorders
Muscle pain-Myalgia	2/17 (11.8%)	2	0/16 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.