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Primary HypercholesterolemiaPhase 3NCT03882905

A Study of SCH 58235 (Ezetimibe) When Added to Ongoing Therapy With a Statin in Participants With Primary Hypercholesterolemia, Known Coronary Heart Disease, or Multiple Cardiovascular Risk Factors (P02173)

A Phase 3 study testing Ezetimibe, Simivastatin and Statin in people with Primary Hypercholesterolemia, run by Organon and Co.

Completed

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

Official record
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Trial summary

This is a study to evaluate the lipid-altering efficacy, safety, and tolerability of ezetimibe when added to ongoing therapy with an 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) in participants with primary hypercholesterolemia, multiple cardiovascular risk factors, or known coronary… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Hypercholesterolemia
What is being tested?
Ezetimibe, Simivastatin and Statin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
769 participants
Where
No sites listed yet
Study dates
31 Jan 2001to 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

  • Currently taking an approved and stable (for at least 6 weeks prior to screening) daily dose of a statin and by history had taken >80% of daily doses for the preceding 6 weeks
  • Have a negative pregnancy test
  • Agree to practice an effective barrier method of birth control during the study if of childbearing potential
  • Females receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, maintain a stable dose and regimen for at least 8 weeks and be willing to continue the same regimen for the duration of the study
  • Must verify previous instruction on an National Cholesterol Education Program (NCEP) Step 1 diet or similar diet and must maintain a stable diet regimen for the duration of the study
  • Weight stability ( ± 2 kg) for at least 6 weeks prior to entry into the study Exclusion Criteria
Show all 29Show fewer
  • History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy
  • Previously enrolled to any study evaluating ezetimibe
  • Pregnant or lactating
  • Consumes greater than 14 alcoholic drinks/week
  • Taking a lipid-altering agent (other than statins) in previous 6 weeks
  • Taking Oral corticosteroids, unless the corticosteroids were for replacement therapy to treat pituitary/adrenal disease and were treated with a stable regimen for at least the previous 6 weeks
  • Treatment with psyllium, other fiber-based laxatives, and other over-the-counter (OTC) therapies that affect serum lipids, unless treated with a stable regimen for at least 6 weeks
  • Taking orlistat
  • Taking cyclosporine
  • Use of any investigational drugs within 30 days
  • Treatment with agents with known interactions with statins including antifungal azoles (itraconazole and ketoconazole), macrolide antibiotics (erythromycin and clarithromycin) and nefazodone or with other potent agents that could significantly interfere with cytochrome P-450 system
  • Congestive heart failure New York Heart Association (NYHA) Class III or IV
  • Uncontrolled cardiac arrhythmias
  • Myocardial infarction, coronary artery bypass surgery or angioplasty within 3 months
  • Unstable or severe peripheral artery disease within 3 months
  • 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
  • Poorly controlled or newly diagnosed (within 3 months) diabetes mellitus, or change in antidiabetic pharmacotherapy (i.e., change in dosage [with the exception of ± 10 units of insulin] or addition of new medication) within 3 months
  • Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia). Clinically euthyroid participants on replacement doses of thyroid hormone are eligible for enrollment if thyroid stimulating hormone (TSH) is within the normal range
  • Impaired renal function, nephrotic syndrome, or other renal disease
  • Active or chronic hepatobiliary or hepatic disease
  • Positive for human immunodeficiency virus (HIV)
  • Cancer within the past 5 years (except for basal cell carcinoma)

Who cannot join

None listed.

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety, and Tolerability of SCH 58235 When Added to Ongoing Therapy With an HMG-CoA Reductase Inhibitor (Statin) in Patients With Primary Hypercholesterolemia, Known Coronary Heart Disease, or Multiple Cardiovascular Risk Factors

This is a study to evaluate the lipid-altering efficacy, safety, and tolerability of ezetimibe when added to ongoing therapy with an 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) in participants with primary hypercholesterolemia, multiple cardiovascular risk factors, or known coronary heart disease (CHD) or CHD-equivalent disease. The statin and dose in use by the participant at screening will be maintained at the same dose for the 8-week treatment phase of the study. Following the treatment, there will be a 6-week cholesterol reversibility phase to determine the rebound effect on cholesterol after ezetimibe is discontinued, but the participant is still on their statin therapy. The primary hypothesis is that the addition of ezetimibe 10 mg/day to ongoing statin monotherapy will result in a further reduction in low-density lipoprotein-cholesterol (LDL-C) compared with placebo.

The protocol was amended to include an extension for participants who complete the base study. The extension will evaluate the safety and tolerability of concomitant treatment of simvastatin with ezetimibe10 mg/day over a 1-year period. All participants in the extension will be converted from current statin to an equivalent dose of simvastatin for 6 weeks. Participants then will be randomly assigned to receive simvastatin coadministered with either with Ezetimibe 10 mg daily or matching placebo for the reminder of study.

Being tested
Ezetimibe, Placebo, Simivastatin, Statin

What participants receive

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

  • EzetimibeDrug

    10 mg tablet, oral, once daily

  • PlaceboDrug

    one tablet, oral, once daily

  • SimivastatinDrug

    Once daily administration at dose to be determined

  • StatinDrug

    Statin administered orally once daily at dose determined by treatment prior to enrollment by personal physician

Study groups in NCT03882905
Study groupRoleWhat they receive
Ezetimibe: Base StudyExperimental10-mg tablet, oral taken once daily concomitantly with the participant' s current statin therapy for 8 weeks.
Receives: Drug: Ezetimibe; Drug: Statin
Placebo: Base StudyPlacebo comparatorPlacebo for ezetimibe 10-mg tablet, oral taken once daily concomitantly with the participant' s current statin therapy for 8 weeks.
Receives: Drug: Placebo; Drug: Statin
Ezetimibe: ExtensionExperimental10-mg tablet, oral taken once daily concomitantly with simvastatin for 48 weeks.
Receives: Drug: Ezetimibe; Drug: Simivastatin
Placebo: ExtensionPlacebo comparatorPlacebo for ezetimibe tablet, oral taken once daily concomitantly with simvastatin for 48 weeks.
Receives: Drug: Placebo; Drug: Simivastatin

What is being measured

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

  1. Percentage Change from Baseline in LDL-C: Base Study

    Measured: Baseline and Week 8 of Base Study

  2. Percentage Participants with Consecutive Elevations ≥3 x Upper Limit of Normal (ULN) in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT): Extension

    Measured: up to 48 weeks (Extension)

Secondary outcomes (12)

  1. Percentage of Participants Achieving LDL-C National Cholesterol Education Program (NCEP) Adult Treatment Program II (ATP II) Target Levels: Base Study

    Measured: Week 8 of Base Study

  2. Percentage Change from Baseline in Total Cholesterol (TC) : Base Study

    Measured: Baseline and Week 8 of Base Study

  3. Percentage Change from Baseline in Triglycerides (TG): Base Study

    Measured: Baseline and Week 8 of Base Study

  4. Percentage Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C) : Base Study

    Measured: Baseline and Week 8 of Base Study

  5. Percentage Change from Baseline in Non-HDL-C: Base Study

    Measured: Baseline and Week 8 of Base Study

  6. Percentage Change from Baseline in Apolipoprotein B (apoB) : Base Study

    Measured: Baseline and Week 8 of Base Study

  7. Percentage Change from Baseline in Apolipoprotein A-I (Apo A-I) : Base Study

    Measured: Baseline and Week 8 of Base Study

  8. Percentage Change from Baseline in Apolipoprotein A-II (Apo A-II) : Base Study

    Measured: Baseline and Week 8 of Base Study

  9. Percentage Change from Baseline in LDL-C:HDL-C Ratio: Base Study

    Measured: Baseline and Week 8 of Base Study

  10. Percentage Change from Baseline in Total-C:HDL-C Ratio: Base Study

    Measured: Baseline and Week 8 of Base Study

  11. Change from Baseline in C-reactive Protein (CRP): Base Study

    Measured: Baseline and Week 8 of Base Study

  12. Percentage Change from Baseline in LDL-C: Extension

    Measured: Baseline (Week 6) and Week 18 of Extension

Timeline

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

  1. First posted20 Mar 2019
  2. Study start31 Jan 2001
  3. Primary completion27 Jul 2001
  4. Study completion27 Jul 2001

Resources

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
769 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03882905
Sponsor's protocol ID
P02173
Other IDs
MK-0653-001, SCH 58235 P02173
Status last verified
Feb 2022
First submitted
19 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

  • Masana L, Mata P, Gagne C, Sirah W, Cho M, Johnson-Levonas AO, Meehan A, Troxell JK, Gumbiner B; Ezetimibe Study Group. Long-term safety and, tolerability profiles and lipid-modifying efficacy of ezetimibe coadministered with ongoing simvastatin treatment: a multicenter, randomized, double-blind, placebo-controlled, 48-week extension study. Clin Ther. 2005 Feb;27(2):174-84. doi: 10.1016/j.clinthera.2005.02.011.

    PubMed 15811480

  • Gagne C, Bays HE, Weiss SR, Mata P, Quinto K, Melino M, Cho M, Musliner TA, Gumbiner B; Ezetimibe Study Group. Efficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia. Am J Cardiol. 2002 Nov 15;90(10):1084-91. doi: 10.1016/s0002-9149(02)02774-1.

    PubMed 12423708

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ezetimibe, Simivastatin and Statin in people with Primary 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 29 inclusion and 0 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?

Percentage Change from Baseline in LDL-C: Base Study (time frame: Baseline and Week 8 of Base Study). 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 NCT03882905, which also lists 2 linked publications.

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.

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