Trial Outcomes & Findings for Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED) (NCT NCT00654628)

Results Overview

Goal attainment percentage of LDL-C after 6-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (\>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level \>130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol \>200 mg/dl or LDL-C level \>130 mg/dl.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

173 participants

Primary outcome timeframe

Baseline and week 6

Results posted on

2024-05-22

Participant Flow

Patients were recruited between August 2007 and July 2009. In one site, 60 patients among the total 152 study population entered into the 6-week extension period after completing the base period for longer follow-up as per IRB requirement in that site.

Participant milestones

Participant milestones
Measure	Ezetimibe/Simvastatin 10/20 mg Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
6-week Active Treatment Period STARTED	173
6-week Active Treatment Period COMPLETED	152
6-week Active Treatment Period NOT COMPLETED	21
6 -Week Extension Period (Single Site) STARTED	60
6 -Week Extension Period (Single Site) COMPLETED	55
6 -Week Extension Period (Single Site) NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Ezetimibe/Simvastatin 10/20 mg Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
6-week Active Treatment Period Adverse Event	9
6-week Active Treatment Period Lost to Follow-up	10
6-week Active Treatment Period Transferred to branch hospital	1
6-week Active Treatment Period Out of window period	1
6 -Week Extension Period (Single Site) Adverse Event	4
6 -Week Extension Period (Single Site) Lost to Follow-up	1

Baseline Characteristics

Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ezetimibe/Simvastatin 10/20 mg n=173 Participants Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
Age, Continuous	57.9 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants
Body Mass Index	25.5 kg/m2 STANDARD_DEVIATION 3.4 • n=5 Participants
Baseline value of Low Density Lipoprotein-C	156.8 mg/dL STANDARD_DEVIATION 30.8 • n=5 Participants
Baseline value of Total Cholesterol	243.7 mg/dL STANDARD_DEVIATION 43.9 • n=5 Participants
Baseline value of High Density Lipoprotein-C	47.1 mg/dL STANDARD_DEVIATION 11.4 • n=5 Participants
Baseline value of Triglycerides	145 mg/dL n=5 Participants
Sitting Diastolic Blood Pressure	78.5 mm Hg STANDARD_DEVIATION 10.2 • n=5 Participants
Sitting Systolic Blood Pressure	133.3 mm Hg STANDARD_DEVIATION 16.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and week 6

Population: Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement.

Goal attainment percentage of LDL-C after 6-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (\>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level \>130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol \>200 mg/dl or LDL-C level \>130 mg/dl.

Outcome measures

Outcome measures
Measure	Ezetimibe/Simvastatin 10/20 mg n=115 Participants Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.	90.4 Percentage of participants

PRIMARY outcome

Timeframe: Baseline and week 12

Population: Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement.

Goal attainment percentage of LDL-C after 12-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (\>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level \>130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol \>200 mg/dl or LDL-C level \>130 mg/dl.