HypercholesterolemiaPhase 3NCT03867110
An Efficacy and Safety Study of Ezetimibe (MK-0653, SCH 58235) in Addition to Atorvastatin Compared to Placebo in Participants With Primary Hypercholesterolemia (MK-0653-013)
A Phase 3 study testing Ezetimibe 10 mg, Atorvastatin 10 mg and Atorvastatin 20 mg in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, balanced-parallel-group, efficacy and safety trial of ezetimibe coadministered with atorvastatin in adult participants with primary hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Ezetimibe 10 mg, Atorvastatin 10 mg and Atorvastatin 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 628 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2000to 27 Jul 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- If female, is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP), or is a WOCBP who has used a contraceptive consistent with local regulations.
- Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen during the study period.
- Primary hypercholesterolemic participants with a plasma LDL-Cholesterol ≥145 mg/dL (3.75 mmol/L) and ≤250 mg/dL (6.48 mmol/L) and plasma triglyceride ≤350 mg/dL (3.99 mmol/L) after adequate drug washout
- Must be willing to observe the National Cholesterol Education Program (NCEP) Step I diet as determined by a Ratio of Ingested Saturated fat and Cholesterol to Calories (RISCC) score not greater than 24 throughout this study. Ability to complete Diet Diaries needs to be demonstrated.
Who cannot join
- Has a history of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
- Underlying disease likely to limit life span to less than 1 year.
- Participants with hypercholesterolemia in whom withholding of approved lipid-lowering therapy would be inappropriate.
- Have previously been randomized in any of the studies evaluating Ezetimibe (SCH 58235).
- Known hypersensitivity or any contraindication to atorvastatin (LIPITOR®).
- Pregnant or lactating women.
Show all 26Show fewer
- Congestive heart failure New York Heart Association (NYHA) Class III or IV.
- Uncontrolled cardiac arrhythmias.
- Myocardial infarction, coronary bypass surgery or angioplasty within 6 months of study entry.
- Unstable or severe peripheral artery disease within 3 months of study entry.
- Unstable angina pectoris.
- Disorders of the hematologic, digestive or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.
- Uncontrolled or newly diagnosed (within 1 month of study entry) diabetes mellitus.
- Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins.
- Known impairment of renal function (plasma creatinine >2.0 mg/dL), dysproteinemia, nephrotic syndrome or other renal disease.
- Active or chronic hepatobiliary or hepatic disease.
- Participants who are known to be Human Immunodeficiency Virus (HIV) positive.
- Participants with known coagulopathy.
- Lipid-altering agents, other than study drugs for the whole duration of the study.
- Oral corticosteroids.
- Cardiovascular drugs such as: beta blockers, calcium channel blockers, ACE inhibitors, nitrates or α-adrenergic blockers or thiazide diuretics will be allowed, provided the dose remains constant for the duration of the study and the participant has received a stable dose for at least 8 weeks before the initial qualifying LDL-C level is drawn. Aspirin up to 325 mg/day is permitted. In addition, aspirin is allowed as a as needed (prn) concomitant medication.
- Treatment with psyllium or other fiber-based laxatives unless treated with a stable regimen for at least 4 weeks before initial qualifying lipid determination. Dose must remain constant throughout the study period.
- Treatment with troglitazone (Rezulin®) unless treated with a stable regimen for at least 6 weeks before initial qualifying lipid determination. Dose must remain constant throughout the study period.
- Treatment with cyclosporine.
- Use of any investigational drugs within 30 days of study entry.
- Treatment with agents with known drug interaction with atorvastatin including antifungal azoles (itraconazole and ketoconazole), macrolide antibiotics (erythromycin and clarithromycin), and nefazodone. In addition, treatment with other agents that may interfere with or induce the CYP3A4 isoenzyme of the cytochrome P450 system should be avoided.
About this study
Official title: A Phase 3, Double-Blind Efficacy and Safety Study of Ezetimibe (SCH 58235) 10 mg in Addition to Atorvastatin Compared to Placebo in Subjects With Primary Hypercholesterolemia (Protocol P00692)
This is a multicenter, randomized, double-blind, placebo-controlled, balanced-parallel-group, efficacy and safety trial of ezetimibe coadministered with atorvastatin in adult participants with primary hypercholesterolemia. The primary hypothesis is that the coadministration of ezetimibe 10 mg/day with atorvastatin (pooled across all doses: 10 mg, 20 mg, 40 mg, 80 mg) will result in a significantly greater reduction in direct low density lipoprotein-cholesterol (LDL-C) when compared with atorvastatin (pooled across all doses: 10 mg, 20 mg, 40 mg, 80 mg) alone and ezetimibe 10 mg alone.
- Conditions
- Hypercholesterolemia
- Being tested
- Placebo, Ezetimibe 10 mg, Atorvastatin 10 mg, Atorvastatin 20 mg, Atorvastatin 40 mg
- Keywords
- Hypercholesterolemia, Ezetimibe, Atorvastatin, Low density lipoprotein-cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Ezetimibe 10 mgDrug
Also called MK-0653, SCH 58235, ZETIA®
Atorvastatin 10 mgDrug
Also called LIPITOR®
Atorvastatin 20 mgDrug
Also called LIPITOR®
Atorvastatin 40 mgDrug
Also called LIPITOR®
Atorvastatin 80 mgDrug
Also called LIPITOR®
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo is to be taken orally once a day (QD) in the morning for 12 consecutive weeks. Receives: Drug: Placebo |
| Ezetimibe 10 mg | Active comparator | Ezetimibe 10 mg (MK-0653, SCH 58235) is to be taken orally QD in the morning for 12 consecutive weeks. Receives: Drug: Ezetimibe 10 mg |
| Atorvastatin 10 mg | Active comparator | Atorvastatin 10 mg is to be taken orally QD in the morning for 12 consecutive weeks. Receives: Drug: Atorvastatin 10 mg |
| Ezetimibe 10 mg + Atorvastatin 10 mg | Experimental | Ezetimibe 10 mg (MK-0653, SCH 58235) + Atorvastatin 10 mg is to be taken orally QD in the morning for 12 consecutive weeks. Receives: Drug: Ezetimibe 10 mg; Drug: Atorvastatin 10 mg |
| Atorvastatin 20 mg | Active comparator | Atorvastatin 20 mg is to be taken orally QD in the morning for 12 consecutive weeks. Receives: Drug: Atorvastatin 20 mg |
| Ezetimibe 10 mg + Atorvastatin 20 mg | Experimental | Ezetimibe 10 mg (MK-0653, SCH 58235) + Atorvastatin 20 mg is to be taken orally QD in the morning for 12 consecutive weeks. Receives: Drug: Ezetimibe 10 mg; Drug: Atorvastatin 20 mg |
| Atorvastatin 40 mg | Active comparator | Atorvastatin 40 mg is to be taken orally QD in the morning for 12 consecutive weeks. Receives: Drug: Atorvastatin 40 mg |
| Ezetimibe 10 mg + Atorvastatin 40 mg | Experimental | Ezetimibe 10 mg (MK-0653, SCH 58235) + Atorvastatin 40 mg is to be taken orally QD in the morning for 12 consecutive weeks. Receives: Drug: Ezetimibe 10 mg; Drug: Atorvastatin 40 mg |
| Atorvastatin 80 mg | Active comparator | Atorvastatin 80 mg is to be taken orally QD in the morning for 12 consecutive weeks. Receives: Drug: Atorvastatin 80 mg |
| Ezetimibe 10 mg + Atorvastatin 80 mg | Experimental | Ezetimibe 10 mg (MK-0653, SCH 58235) + Atorvastatin 80 mg is to be taken orally QD in the morning for 12 consecutive weeks. Receives: Drug: Ezetimibe 10 mg; Drug: Atorvastatin 80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline at Week 12 of Plasma Low Density Lipoprotein Cholesterol (LDL-C)
Plasma LDL-C determined following a standard ultracentrifugation / precipitation (quantification) procedure (direct LDL-C). Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
Secondary outcomes (13)
Percent Change from Baseline at Week 12 for Calculated Low Density Lipoprotein-Cholesterol (LDL-C)
Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for Total Cholesterol (TC)
Participants had TC levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for Triglycerides (TG)
Participants had TG levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for High Density-Lipoprotein-Cholesterol (HDL-C)
Participants had HDL-C levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for Apolipoprotein B (Apo B)
Participants had Apo B levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for Non-High Density-Lipoprotein-Cholesterol (Non-HDL-C)
Participants had Non-HDL-C levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for High Density-Lipoprotein 2-Cholesterol (HDL2-C)
Participants had HDL2-C levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for High Density-Lipoprotein 3-Cholesterol (HDL3-C)
Participants had HDL3-C levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for Apolipoprotein A-I (Apo A-I),
Participants had Apo A1 levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for Direct Low Density-Lipoprotein 3-Cholesterol/High Density-Lipoprotein 3-Cholesterol (LDL-C/HDL-C) Ratio
Participants had LDL-C and HDL-C levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline in the LDL-C/HDL-C ratio was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for Direct Total Cholesterol/High Density-Lipoprotein 3-Cholesterol (TC/HDL-C) Ratio
Participants had TC and HDL-C levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline in the TC/HDL-C ratio was calculated.
Measured: Baseline and Week 12
Percent Change from Baseline at Week 12 for Lipoprotein (a) (Lp[a])
Participants had Lp(a) levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
Measured: Baseline and Week 12
The Percentage of Participants Achieving National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP II) Target Goal for Direct Low Density Lipoprotein-Cholesterol (LDL-C)
LDL cholesterol level goal is <100 mg per deciliter (2.60 mmol per L)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start6 Mar 2000
- Primary completion27 Jul 2001
- Study completion27 Jul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867110
- Sponsor's protocol ID
- P00692
- Other IDs
- MK-0653-013, P00692
- Status last verified
- Feb 2022
- First submitted
- 6 Mar 2019
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ballantyne CM, Houri J, Notarbartolo A, Melani L, Lipka LJ, Suresh R, Sun S, LeBeaut AP, Sager PT, Veltri EP; Ezetimibe Study Group. Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Circulation. 2003 May 20;107(19):2409-15. doi: 10.1161/01.CIR.0000068312.21969.C8. Epub 2003 Apr 28.
PubMed 12719279
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind Efficacy and Safety Study of Ezetimibe (SCH 58235) 10 mg in Addition to Atorvastatin Compared to Placebo in Subjects With Primary Hypercholesterolemia (Protocol P00692)
- ClinicalTrials.gov ID
- NCT03867110
- Acronym / sponsor ID
- P00692
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Ezetimibe, Atorvastatin, Low density lipoprotein-cholesterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2000 (actual)
- Primary completion
- 27 Jul 2001 (actual)
- Study completion
- 27 Jul 2001 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled, balanced-parallel-group, efficacy and safety trial of ezetimibe coadministered with atorvastatin in adult participants with primary hypercholesterolemia. The primary hypothesis is that the coadministration of ezetimibe 10 mg/day with atorvastatin (pooled across all doses: 10 mg, 20 mg, 40 mg, 80 mg) will result in a significantly greater reduction in direct low density lipoprotein-cholesterol (LDL-C) when compared with atorvastatin (pooled across all doses: 10 mg, 20 mg, 40 mg, 80 mg) alone and ezetimibe 10 mg alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is to be taken orally once a day (QD) in the morning for 12 consecutive weeks. |
| Ezetimibe 10 mg | Active comparator | Drug: Ezetimibe 10 mgEzetimibe 10 mg (MK-0653, SCH 58235) is to be taken orally QD in the morning for 12 consecutive weeks. |
| Atorvastatin 10 mg | Active comparator | Drug: Atorvastatin 10 mgAtorvastatin 10 mg is to be taken orally QD in the morning for 12 consecutive weeks. |
| Ezetimibe 10 mg + Atorvastatin 10 mg | Experimental | Drug: Ezetimibe 10 mg, Drug: Atorvastatin 10 mgEzetimibe 10 mg (MK-0653, SCH 58235) + Atorvastatin 10 mg is to be taken orally QD in the morning for 12 consecutive weeks. |
| Atorvastatin 20 mg | Active comparator | Drug: Atorvastatin 20 mgAtorvastatin 20 mg is to be taken orally QD in the morning for 12 consecutive weeks. |
| Ezetimibe 10 mg + Atorvastatin 20 mg | Experimental | Drug: Ezetimibe 10 mg, Drug: Atorvastatin 20 mgEzetimibe 10 mg (MK-0653, SCH 58235) + Atorvastatin 20 mg is to be taken orally QD in the morning for 12 consecutive weeks. |
| Atorvastatin 40 mg | Active comparator | Drug: Atorvastatin 40 mgAtorvastatin 40 mg is to be taken orally QD in the morning for 12 consecutive weeks. |
| Ezetimibe 10 mg + Atorvastatin 40 mg | Experimental | Drug: Ezetimibe 10 mg, Drug: Atorvastatin 40 mgEzetimibe 10 mg (MK-0653, SCH 58235) + Atorvastatin 40 mg is to be taken orally QD in the morning for 12 consecutive weeks. |
| Atorvastatin 80 mg | Active comparator | Drug: Atorvastatin 80 mgAtorvastatin 80 mg is to be taken orally QD in the morning for 12 consecutive weeks. |
| Ezetimibe 10 mg + Atorvastatin 80 mg | Experimental | Drug: Ezetimibe 10 mg, Drug: Atorvastatin 80 mgEzetimibe 10 mg (MK-0653, SCH 58235) + Atorvastatin 80 mg is to be taken orally QD in the morning for 12 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- If female, is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP), or is a WOCBP who has used a contraceptive consistent with local regulations.
- Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen during the study period.
- Primary hypercholesterolemic participants with a plasma LDL-Cholesterol ≥145 mg/dL (3.75 mmol/L) and ≤250 mg/dL (6.48 mmol/L) and plasma triglyceride ≤350 mg/dL (3.99 mmol/L) after adequate drug washout
- Must be willing to observe the National Cholesterol Education Program (NCEP) Step I diet as determined by a Ratio of Ingested Saturated fat and Cholesterol to Calories (RISCC) score not greater than 24 throughout this study. Ability to complete Diet Diaries needs to be demonstrated.
Key exclusion criteria (26 listed)
- Has a history of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
- Underlying disease likely to limit life span to less than 1 year.
- Participants with hypercholesterolemia in whom withholding of approved lipid-lowering therapy would be inappropriate.
- Have previously been randomized in any of the studies evaluating Ezetimibe (SCH 58235).
- Known hypersensitivity or any contraindication to atorvastatin (LIPITOR®).
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 |
|---|---|---|
| Placebo | Drug | Placebo |
| Ezetimibe 10 mgAlso: MK-0653, SCH 58235, ZETIA® | Drug | Ezetimibe 10 mg, Ezetimibe 10 mg + Atorvastatin 10 mg, Ezetimibe 10 mg + Atorvastatin 20 mg, Ezetimibe 10 mg + Atorvastatin 40 mg, Ezetimibe 10 mg + Atorvastatin 80 mg |
| Atorvastatin 10 mgAlso: LIPITOR® | Drug | Atorvastatin 10 mg, Ezetimibe 10 mg + Atorvastatin 10 mg |
| Atorvastatin 20 mgAlso: LIPITOR® | Drug | Atorvastatin 20 mg, Ezetimibe 10 mg + Atorvastatin 20 mg |
| Atorvastatin 40 mgAlso: LIPITOR® | Drug | Atorvastatin 40 mg, Ezetimibe 10 mg + Atorvastatin 40 mg |
| Atorvastatin 80 mgAlso: LIPITOR® | Drug | Atorvastatin 80 mg, Ezetimibe 10 mg + Atorvastatin 80 mg |
Primary outcome
Percent Change from Baseline at Week 12 of Plasma Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and Week 12
Plasma LDL-C determined following a standard ultracentrifugation / precipitation (quantification) procedure (direct LDL-C). Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The percent change from baseline was calculated.
13 secondary outcomes
Percent Change from Baseline at Week 12 for Calculated Low Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for Total Cholesterol (TC)
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for Triglycerides (TG)
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for High Density-Lipoprotein-Cholesterol (HDL-C)
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for Apolipoprotein B (Apo B)
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for Non-High Density-Lipoprotein-Cholesterol (Non-HDL-C)
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for High Density-Lipoprotein 2-Cholesterol (HDL2-C)
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for High Density-Lipoprotein 3-Cholesterol (HDL3-C)
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for Apolipoprotein A-I (Apo A-I),
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for Direct Low Density-Lipoprotein 3-Cholesterol/High Density-Lipoprotein 3-Cholesterol (LDL-C/HDL-C) Ratio
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for Direct Total Cholesterol/High Density-Lipoprotein 3-Cholesterol (TC/HDL-C) Ratio
Time frame: Baseline and Week 12
Percent Change from Baseline at Week 12 for Lipoprotein (a) (Lp[a])
Time frame: Baseline and Week 12
The Percentage of Participants Achieving National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP II) Target Goal for Direct Low Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Results publication: PubMed 12719279Ballantyne CM, Houri J, Notarbartolo A, Melani L, Lipka LJ, Suresh R, Sun S, LeBeaut AP, Sager PT, Veltri EP; Ezetimibe Study Group. Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Circulation. 2003 May 20;107(19):2409-15. doi: 10.1161/01.CIR.0000068312.21969.C8. Epub 2003 Apr 28.
- Individual participant dataSharing planned: No
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ezetimibe 10 mg, Atorvastatin 10 mg and Atorvastatin 20 mg 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 26 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 10 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent Change from Baseline at Week 12 of Plasma Low Density Lipoprotein Cholesterol (LDL-C) (time frame: Baseline and Week 12). 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 NCT03867110, 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 10 May 2024.