HypercholesterolemiaPhase 4BRAVONCT00654628

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

A Phase 4 study testing ezetimibe (+) simvastatin in people with Hypercholesterolemia, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 20 to 79 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: ezetimibe (+) simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 173 participants
Where: No sites listed yet
Study dates: 1 Aug 2007to 1 Jul 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

About this study

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

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

Conditions: Hypercholesterolemia
Being tested: ezetimibe (+) simvastatin
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ezetimibe (+) simvastatinDrug
Also called Vytorin®, MK653A
Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.

Study groups in NCT00654628
Study group	Role	What they receive
1	Experimental	Patients with intermediate or high risk dyslipidemia will be enrolled to receive treatment with Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks Receives: Drug: ezetimibe (+) simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and week 6
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.
Measured: Baseline and week 12

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20071 Jul 2009

First posted8 Apr 2008 (estimated)
Study start1 Aug 2007
Primary completion1 Jul 2009
Study completion1 Jul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00654628
Sponsor's protocol ID: 0653A-172
Other IDs: 2008_010
Acronym: BRAVO
Status last verified: Feb 2022
First submitted: 2 Apr 2008
Last updated: 22 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Huang JC, Lee TY, Liou MJ, Lin CM, Pei D, Chen ZC, Liu RT, Kwok CF. Begin with the real-world patients of non-goal-achieved hypercholesterolemia in taiwan through the ezetimibe/simvastatin tablet - The BRAVO Study. Curr Med Res Opin. 2011 Aug;27(8):1645-51. doi: 10.1185/03007995.2011.594425. Epub 2011 Jun 23.
PubMed 21699369

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients
ClinicalTrials.gov ID: NCT00654628
Acronym / sponsor ID: BRAVO / 0653A-172
Conditions: Hypercholesterolemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 1 Aug 2007 (actual)
Primary completion: 1 Jul 2009 (actual)
Study completion: 1 Jul 2009 (actual)
First posted: 8 Apr 2008 (estimated)
Results: Posted 26 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: ezetimibe (+) simvastatinPatients with intermediate or high risk dyslipidemia will be enrolled to receive treatment with Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks

Who may qualify

Ages: 20 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ezetimibe (+) simvastatinAlso: Vytorin®, MK653AVytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.	Drug	1

Primary outcome

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

8 secondary outcomes

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

Results and safety

Results posted to the registry on 26 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ezetimibe/Simvastatin 10/20 mg	173	152

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

Time frame: Baseline and week 6. Number. Unit: Percentage of participants

Measure	Ezetimibe/Simvastatin 10/20 mg n = 115
Value	90.4

Population analysed: 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.

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

Time frame: Baseline and week 12. Number. Unit: Percentage of participants

Measure	Ezetimibe/Simvastatin 10/20 mg n = 49
Value	87.8

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ezetimibe/Simvastatin 10/20 mg	1 of 173 (0.6%)	34 of 173 (19.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21699369Huang JC, Lee TY, Liou MJ, Lin CM, Pei D, Chen ZC, Liu RT, Kwok CF. Begin with the real-world patients of non-goal-achieved hypercholesterolemia in taiwan through the ezetimibe/simvastatin tablet - The BRAVO Study. Curr Med Res Opin. 2011 Aug;27(8):1645-51. doi: 10.1185/03007995.2011.594425. Epub 2011 Jun 23.
Individual participant dataSharing planned: No

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ezetimibe (+) simvastatin in people with Hypercholesterolemia, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment. (time frame: Baseline and week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00654628, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.