HypercholesterolemiaPhase 4NCT00319449
Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)
A Phase 4 study testing Ezetimibe and Atorvastatin 10 mg in people with Hypercholesterolemia and Coronary Arteriosclerosis, run by Organon and Co.
Trial summary
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia, Coronary Arteriosclerosis
- What is being tested?
- Ezetimibe and Atorvastatin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Oct 2006
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have an LDL-C concentration >= 3.3 mmol/L (130 mg/dL) to <= 4.9 mmol/L (190 mg/dL) using the Freidewald calculation.
- Participants must have triglyceride concentrations of < 3.99 mmol/L (350 mg/dL).
- Participants must have two or more coronary heart disease risk factors listed below:
- Current cigarette smoking
- Hypertension (BP >= 140/90 mmHg or on antihypertensive medication)
- Low HDL cholesterol (< 40 mg/dL)
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- Family history of premature CHD (CHD in male first degree relative < 55 years; CHD in female first degree relative < 65 years)
- Age (Men >= 45 years; women >= 55 years)
- Participant must be currently taking atorvastatin 10 mg daily and by history has taken 80% of daily doses for the 6 weeks prior to participating.
- Participants must have liver transaminases (ALT, AST) < 50% above the upper limit of normal, with no active liver disease, and CK < 50% above the upper limit of normal.
- Participants must have maintained a cholesterol lowering diet, exercise program, and stable weight for at least 4 weeks prior to the study and be willing to continue the same diet and exercise program during the study.
- Women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and be willing to continue the same regimen for the duration of the study.
Who cannot join
- Participants who meet any of the following criteria will be excluded:
- Body mass index (BMI = weight [kg]/height2[m]) is >= 30 Kg/m2.
- Consume > 14 alcoholic drinks per week.
- Women who are pregnant or nursing.
- Congestive heart failure defined by NYHA as Class III or IV.
- Uncontrolled cardiac arrhythmia.
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- Coronary heart disease (CHD).
- Unstable or severe peripheral artery disease within 3 months of participating
- Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 160 mm Hg or diastolic > 100 mm Hg.
- Type I or Type II diabetes mellitus.
- Secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to hypothyroidism.
- Impaired renal function (creatinine > 2.0 mg/dL) or nephrotic syndrome.
- Known HIV positive.
- Cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas).
- History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
- Participants who are on any of the following concomitant medications:
- Participants who are on medications that are potent inhibitors of CYP3A4, including cyclosporine, systemic itraconazole, fluconazole, and ketoconazole, erythromycin or clarithromycin, nefazodone, mibefradil, protease inhibitors and large amounts of grapefruit juice (> 1 quart/day).
- Participants who are on lipid-lowering agents (other atorvastatin): niacin (> 200 mg/day)
- Participants who are on over the counter lipid lowering agents such as fish oils, garlic and cholestin
- Participants who are on oral corticosteroids, unless used as replacement therapy for pituitary/adrenal disease and the subject is on a stable regimen for at least 6 weeks.
- Participants who are currently using psyllium, other fiber-based laxatives, and/or any other OTC therapy known to affect serum lipid levels (phytosterol margarine), and have not been on a stable regimen for at least 5 weeks and who do not agree to remain on this regimen throughout the study.
- Participant who are currently using orlistat or sibutramine.
About this study
Official title: A Single Center, Randomized, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, And Tolerability Of The Daily Co-administration Of Ezetimibe 10 Mg Or Ezetimibe Placebo To Ongoing Treatment With Atorvastatin 10 Mg In Subjects With Primary Hypercholesterolemia And Multiple Coronary Heart Disease Risk Factors in Indonesian Population.
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.
- Conditions
- Hypercholesterolemia, Coronary Arteriosclerosis
- Being tested
- Ezetimibe, Placebo, Atorvastatin 10 mg
- Medical subject headings
- Hypercholesterolemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin
PlaceboDrug
10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin
Atorvastatin 10 mgDrug
10 mg/day atorvastatin, orally, (ongoing treatment in participants)
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe 10 mg | Experimental | Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin. Receives: Drug: Ezetimibe; Drug: Atorvastatin 10 mg |
| Placebo 10 mg | Placebo comparator | Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin. Receives: Drug: Placebo; Drug: Atorvastatin 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5]) before and after treatment.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)
12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5] after treatment for 6 weeks.
Measured: 6 weeks post treatment
High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
12-hour fasting blood samples were collected in participants and the high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol was measured with the basic lipid panel test.
Measured: 6 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startSep 2005
- Primary completionOct 2006
- Study completionOct 2006
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT. Schering-Plough. Tbk Indonesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319449
- Sponsor's protocol ID
- P04060
- Status last verified
- Feb 2022
- First submitted
- 28 Apr 2006
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, And Tolerability Of The Daily Co-administration Of Ezetimibe 10 Mg Or Ezetimibe Placebo To Ongoing Treatment With Atorvastatin 10 Mg In Subjects With Primary Hypercholesterolemia And Multiple Coronary Heart Disease Risk Factors in Indonesian Population.
- ClinicalTrials.gov ID
- NCT00319449
- Acronym / sponsor ID
- P04060
- Conditions
- Hypercholesterolemia, Coronary Arteriosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- PT. Schering-Plough. Tbk Indonesia
- Study start
- Sep 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Posted 10 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe 10 mg | Experimental | Drug: Ezetimibe, Drug: Atorvastatin 10 mgParticipants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin. |
| Placebo 10 mg | Placebo comparator | Drug: Placebo, Drug: Atorvastatin 10 mgParticipants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants must have an LDL-C concentration >= 3.3 mmol/L (130 mg/dL) to <= 4.9 mmol/L (190 mg/dL) using the Freidewald calculation.
- Participants must have triglyceride concentrations of < 3.99 mmol/L (350 mg/dL).
- Participants must have two or more coronary heart disease risk factors listed below:
- Participant must be currently taking atorvastatin 10 mg daily and by history has taken 80% of daily doses for the 6 weeks prior to participating.
- Participants must have liver transaminases (ALT, AST) < 50% above the upper limit of normal, with no active liver disease, and CK < 50% above the upper limit of normal.
Key exclusion criteria (22 listed)
- Participants who meet any of the following criteria will be excluded:
- Body mass index (BMI = weight [kg]/height2[m]) is >= 30 Kg/m2.
- Consume > 14 alcoholic drinks per week.
- Women who are pregnant or nursing.
- Congestive heart failure defined by NYHA as Class III or IV.
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 |
|---|---|---|
| Ezetimibe10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin | Drug | Ezetimibe 10 mg |
| Placebo10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin | Drug | Placebo 10 mg |
| Atorvastatin 10 mg10 mg/day atorvastatin, orally, (ongoing treatment in participants) | Drug | Ezetimibe 10 mg, Placebo 10 mg |
Primary outcome
Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
Time frame: Baseline and 6 weeks
12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5]) before and after treatment.
2 secondary outcomes
Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)
Time frame: 6 weeks post treatment
High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
Time frame: 6 weeks post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ezetimibe and Atorvastatin 10 mg in people with Hypercholesterolemia and Coronary Arteriosclerosis, 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 12 inclusion and 22 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 9 Feb 2022. 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. Some participants in this study may receive a placebo. 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 10 May 2011). 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?
Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2022.