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

Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654628

Acronym

BRAVO

Enrollment

173

Registered

2008-04-08

Start date

2007-08-01

Completion date

2009-07-01

Last updated

2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

The purpose of this study is to determine the safety and tolerability of ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.

Interventions

DRUGezetimibe (+) simvastatin

Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Male Or Female Patient, 20 Through 79 Years Of Age * Newly Diagnosed Dyslipidemia Patients Including: 1) Intermediate Risk (\>2 Risk Factors) With Total Cholesterol level above 200 mg/dL Or Low Density Lipoprotein-C (LDL-C) level\> 130 mg/dLwho failed a 3-Month diet control period, or 2) High Risk Patients with history of Coronary artery disease Or diabetes and having a total Cholesterol\> 200 mg/dL Or LDL-C level\> 130 mg/dL * Willing To Follow An National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) Or Similar Cholesterol-Lowering Diet For The Duration Of The Study * Female Patients Receiving Hormone Therapy (Including Hormone Replacement Therapy, And Estrogen Antagonist/Agonist, Or Oral Contraceptives) If Maintained On A Stable Dose And Regimen For At Least 8 Weeks Prior To Visit 1 And If Willing To Continue The Same Regimen Throughout The Study

Exclusion criteria

* Women Who Are Pregnant Or Lactating * Has A History Of Cancer Within The Past 5 Years (Except For Dermatological Basal Cell Or Squamous Cell Carcinoma) * Patients Hypersensitive To Simvastatin Or Ezetimibe * Any Condition Or Situation Which, In The Opinion Of The Investigator, Might Pose A Risk To The Patient Or Confound The Results Of The Study * History Of Mental Instability, Drug/Alcohol Abuse Within The Past 5 Years, Or Major Psychiatric Illness Not Adequately Controlled By Pharmacotherapy * Nephritic Syndrome Or Other Clinically Significant Renal Disease Resulting In Impaired Renal Function, Defined As Serum Creatinine ≧ 1.5 Mg/Dl * Alanine Aminotransferase (ALT), And Aspartate Aminotransferase (AST) above 1.5 X Upper Limit Of Normal (Uln) Or With Active Liver Disease * Congestive Heart Failure (New York Heart Association (NYHA) III Or IV), Uncontrolled Cardiac Arrythmias, Uncontrolled Hypertension (Systolic Blood Pressure (SBP) \>160 mm Hg Or Diastolic Blood Pressure (DBP) \>100 mm Hg), Unstable Angina Pectoris Or Severe Peripheral Artery Disease, Or Experienced Myocardial Infarction, Coronary Artery Bypass Surgery, Angioplasty Within 3 Months * Unstable Diabetes Mellitus Patient (Hemoglobin A1c (HbA1c) \> 8.5%) Or Newly Diagnosed (Within 3 Months) Or A Change In Anti-Diabetic Pharmacotherapy Within 3 Months Of Screening * Secondary Dyslipidemia (E.G., Hypothyroidism) * Disorders Of The Hematologic, Digestive, Or Central Nervous Systems Including Cerebrovascular Disease And Degenerative Disease That Would Limit Study Evaluation Or Participation * History Of Active Or Chronic Hepatobiliary Disease Or Cholelithiasis But Have Not Undergone Cholecystectomy

Design outcomes

Primary

Measure	Time frame	Description
The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.	Baseline and week 6	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.
The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.	Baseline and week 12	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.

Secondary

Measure	Time frame
Mean Percent Change of Triglycerides From Baseline at Week 12	Baseline and week 12
Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6	Baseline and week 6
Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12	Baseline and week 12
Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12	Baseline and week 12
Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6	Baseline and week 6
Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6	Baseline and week 6
Mean Percent Change of Triglycerides From Baseline at Week 6	Baseline and week 6
Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12	Baseline and week 12

Other

Measure	Time frame
Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12	Baseline and week 12
Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6	Baseline and week 6

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
Ezetimibe/Simvastatin 10/20 mg Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period	173
Total	173

Withdrawals & dropouts

Period	Reason	FG000
6-week Active Treatment Period	Adverse Event	9
6-week Active Treatment Period	Lost to Follow-up	10
6-week Active Treatment Period	Out of window period	1
6-week Active Treatment Period	Transferred to branch hospital	1
6 -Week Extension Period (Single Site)	Adverse Event	4
6 -Week Extension Period (Single Site)	Lost to Follow-up	1

Baseline characteristics

Characteristic	Ezetimibe/Simvastatin 10/20 mg
Age, Continuous	57.9 years STANDARD_DEVIATION 10.4
Baseline value of High Density Lipoprotein-C	47.1 mg/dL STANDARD_DEVIATION 11.4
Baseline value of Low Density Lipoprotein-C	156.8 mg/dL STANDARD_DEVIATION 30.8
Baseline value of Total Cholesterol	243.7 mg/dL STANDARD_DEVIATION 43.9
Baseline value of Triglycerides	145 mg/dL
Body Mass Index	25.5 kg/m2 STANDARD_DEVIATION 3.4
Sex: Female, Male Female	100 Participants
Sex: Female, Male Male	73 Participants
Sitting Diastolic Blood Pressure	78.5 mm Hg STANDARD_DEVIATION 10.2
Sitting Systolic Blood Pressure	133.3 mm Hg STANDARD_DEVIATION 16.6

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	34 / 173
serious Total, serious adverse events	1 / 173

Outcome results

Primary

The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.

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.

Time frame: 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.

Arm	Measure	Value (NUMBER)
Ezetimibe/Simvastatin 10/20 mg	The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.	87.8 Percentage of participants

Primary

The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.

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.

Time frame: Baseline and week 6

Arm	Measure	Value (NUMBER)
Ezetimibe/Simvastatin 10/20 mg	The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.	90.4 Percentage of participants

Secondary