HypercholesterolemiaPhase 3NCT00650819
Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED)
A Phase 3 study testing Ezetimibe + Simvastatin, Simvastatin and Ezetimibe in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
This is a multicenter, randomized, double blind; active-controlled parallel groups study enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe, simvastatin, or the combination once daily for 8 weeks to determine the effect on LDL-cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Ezetimibe + Simvastatin, Simvastatin and Ezetimibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2004to 1 Feb 2005
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be >= 18 years and <= 75 years of age.
- Subjects with Primary Hypercholesterolemia must be finished the Lab test listed below and the results must be available at the time of randomization at Visit 3 (Baseline Visit).
- LDL-C concentration > 3.64 mmol/L (140mg/dL) to <= 6.3 mmol/L (250 mg/dL) using the Friedewald calculation
- Total cholesterol (TC) > 5.2mmol/L (200mg/dL) to < 12.7mmol/L (500mg/dL)
- Triglyceride concentrations of <= 3.99 mmol/L (350 mg/dL)
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- Liver transaminases (ALT, AST) must be within normal limits, with no active liver disease and CK < 50% above the upper limit of normal
- Clinical laboratory tests (CBC, blood chemistries, urinalysis) must be within normal limits
- Subjects must report a stable weight history for at least 4 weeks prior to entry into study at Visit 3 (Baseline Visit).
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g. medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
- Subjects must be free of any clinically significant diseases other than hyperlipidemia that would interfere with study evaluations.
- Subjects must understand and be able to adhere to the dosing and visit schedules, and must agree to remain on a cholesterol-lowering diet for the duration of the study.
Who cannot join
- Subjects whose body mass index (BMI = weight [kg]/height2 [m]) is >= 30 Kg/m^2 at Visit 3 (Baseline Visit).
- Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.
- Subjects who consume > 14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits).
- Any condition or situation, which in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
- Women who are pregnant or nursing
- Subjects who have not observed the designated washout periods for any of the prohibited medications outlined in protocol
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- Congestive heart failure defined by NYHA as Class III or IV.
- Uncontrolled cardiac arrhythmia.
- 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 within 6 months of study entry.
- Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 160 mm Hg or diastolic > 100 mm Hg of study entry.
- Uncontrolled (as determined by HbA1c > 7 %) or newly diagnosed (within 1month of study entry) diabetes mellitus.
- Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, i.e., secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to hypothyroidism (TSH above upper limit of normal). Subjects with a history of hypothyroidism who are on a stable therapy of thyroid hormone replacement for at least 6 weeks are eligible for enrollment if TSH levels are within normal limits before enrollment.
- Known Impaired renal function (plasma creatinine > 2.0 mg/dL), or nephrotic syndrome of study entry.
- Disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.
- 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.
- Subjects with known coagulopathy (PT and PTT at Visit 1 >1.25 times control)
- Women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives.
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.
About this study
Official title: A Multicenter, Double-blind, Randomized, Active-controlled Parallel Groups Study Comparing The Efficacy and Safety of The Daily Co-Administration of Ezetimibe 10 mg With Simvastatin 20 mg Vs Simvastatin Or Ezetimibe Alone in Subjects With Primary Hypercholesterolemia
This is a multicenter, randomized, double blind; active-controlled parallel groups study enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe, simvastatin, or the combination once daily for 8 weeks to determine the effect on LDL-cholesterol.
- Conditions
- Hypercholesterolemia
- Being tested
- Ezetimibe + Simvastatin, Simvastatin, Ezetimibe
- 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 SCH 58235
ezetimibe 10 mg plus simvastatin 20 mg once daily for 8 weeks
SimvastatinDrug
simvastatin 20 mg plus ezetimibe placebo once daily for 8 weeks
EzetimibeDrug
Also called SCH 58235
Ezetimibe 10 mg plus simvastatin placebo once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe + Simvastatin | Experimental | Not described Receives: Drug: Ezetimibe + Simvastatin |
| Simvastatin | Active comparator | Not described Receives: Drug: Simvastatin |
| Ezetimibe | Active comparator | Not described Receives: Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in LDL-C concentration.
Measured: 8 weeks
Secondary outcomes (1)
Percent change from baseline in total cholesterol, triglycerides, and HDL-C.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study start1 Jun 2004
- Primary completion1 Feb 2005
- Study completion1 Feb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650819
- Sponsor's protocol ID
- P03757
- Status last verified
- Feb 2022
- First submitted
- 31 Mar 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Active-controlled Parallel Groups Study Comparing The Efficacy and Safety of The Daily Co-Administration of Ezetimibe 10 mg With Simvastatin 20 mg Vs Simvastatin Or Ezetimibe Alone in Subjects With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00650819
- Acronym / sponsor ID
- P03757
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jun 2004 (actual)
- Primary completion
- 1 Feb 2005 (actual)
- Study completion
- 1 Feb 2005 (actual)
- First posted
- 2 Apr 2008 (estimated)
- 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; active-controlled parallel groups study enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe, simvastatin, or the combination once daily for 8 weeks to determine the effect on LDL-cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe + Simvastatin | Experimental | Drug: Ezetimibe + Simvastatin |
| Simvastatin | Active comparator | Drug: Simvastatin |
| Ezetimibe | Active comparator | Drug: Ezetimibe |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be >= 18 years and <= 75 years of age.
- Subjects with Primary Hypercholesterolemia must be finished the Lab test listed below and the results must be available at the time of randomization at Visit 3 (Baseline Visit).
- Subjects must report a stable weight history for at least 4 weeks prior to entry into study at Visit 3 (Baseline Visit).
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g. medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
Key exclusion criteria (22 listed)
- Subjects whose body mass index (BMI = weight [kg]/height2 [m]) is >= 30 Kg/m^2 at Visit 3 (Baseline Visit).
- Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.
- Subjects who consume > 14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits).
- Any condition or situation, which in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
- Women who are pregnant or nursing
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: SCH 58235ezetimibe 10 mg plus simvastatin 20 mg once daily for 8 weeks | Drug | Ezetimibe + Simvastatin |
| Simvastatinsimvastatin 20 mg plus ezetimibe placebo once daily for 8 weeks | Drug | Simvastatin |
| EzetimibeAlso: SCH 58235Ezetimibe 10 mg plus simvastatin placebo once daily for 8 weeks | Drug | Ezetimibe |
Primary outcome
Percent change from baseline in LDL-C concentration.
Time frame: 8 weeks
1 secondary outcome
Percent change from baseline in total cholesterol, triglycerides, and HDL-C.
Time frame: 8 weeks
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 15 Aug 2024.
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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 3 study testing Ezetimibe + Simvastatin, Simvastatin and Ezetimibe 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 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 15 Aug 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 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 in LDL-C concentration. (time frame: 8 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 15 Aug 2024.