HypercholesterolemiaPhase 1NCT00651144
Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With High Cholesterol (P03317)
A Phase 1 study testing Ezetimibe + Rosuvastatin, Rosuvastatin and Ezetimibe in people with Hypercholesterolemia and Atherosclerosis, run by Organon and Co.
Trial summary
The purpose of this study is to obtain data of the coadministration of ezetimibe and rosuvastatin to support the concomitant use of these two drugs in patients requiring additional cholesterol-lowering management. Treatment is administered for 14 days. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hypercholesterolemia, Atherosclerosis
- What is being tested?
- Ezetimibe + Rosuvastatin, Rosuvastatin and Ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to May 2003
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females between the ages of 18 and 55 years inclusive, having a Body Mass Index (BMI) between 19-31 inclusive. BMI=weight (kg)/height (m^2).
- Subjects must have untreated hypercholesterolemia with a directly measured fasting LDL-C >=130 mg/dL (3.37 mmol/L) at Screening and on Day -1. Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.
- Subjects must have a normal or clinically acceptable physical exam and ECG (12-lead recorded at 25 mm/s and reporting heart rate and PR, QRS, QT, and QTc intervals).
- Subjects' clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/ sponsor.
- Screen for drugs with high potential for abuse must be negative.
- Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules.
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- Subjects must be willing to comply with the NCEP Step 1 diet for at least one week as outpatients, and during the inpatient treatment period.
- Female subjects must be of nonchildbearing potential (ie, surgically sterilized or postmenopausal for at least one year), or, if they are of childbearing potential they must be using a medically accepted method of birth control prior to Screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). Females of childbearing potential should be counseled in the appropriate use of birth control while in this study. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
- Female subjects must have a negative serum pregnancy test (beta-hCG) at Screening.
Who cannot join
- Female subjects who are pregnant, intend to become pregnant, or are nursing.
- Subjects who previously received or were treated with ezetimibe (SCH 58235) or rosuvastatin.
- Subjects who previously received or were treated with lipid lowering drugs (including OTC fish oil and phytosterols) within 6 weeks of Visit 1.
- Any subject who does not comply with the requirement that he/she should not have used any prescription or over-the-counter drugs (except for aspirin or acetaminophen [paracetamol]) within two weeks prior to study drug administration nor alcohol within 48 hours prior to study drug administration.
- Subjects who have used any investigational drugs or donated blood within 30 days of study entry.
- Subjects with pre-existing gallbladder disease or a history of liver function test abnormalities.
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- Subjects who smoke more than ten cigarettes or equivalent tobacco use per day.
- Subjects who have a clinically significant allergy or intolerance to foods or drugs, especially to any component of ezetimibe (ZETIA™/EZETROL™) or rosuvastatin (CRESTOR™).
- Subjects who are positive for HIV antibodies, hepatitis B surface antigen or hepatitis C antibody.
- Subjects with a history of mental instability or who have been or are being treated for mood disorders.
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
- Subjects who are participating in any other clinical study.
- Subjects who are part of the staff personnel directly involved with this study.
- Subjects who are a family member of the investigational study staff.
About this study
Official title: SCH 058235: Assessment of a Multiple-Dose Drug Interaction Between Ezetimibe and Rosuvastatin in Healthy Hypercholesterolemic Subjects
The purpose of this study is to obtain data of the coadministration of ezetimibe and rosuvastatin to support the concomitant use of these two drugs in patients requiring additional cholesterol-lowering management. Treatment is administered for 14 days.
- Conditions
- Hypercholesterolemia, Atherosclerosis
- Being tested
- Ezetimibe + Rosuvastatin, Rosuvastatin, Placebo, Ezetimibe
- Medical subject headings
- Hypercholesterolemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe + RosuvastatinDrug
Also called Zetia, SCH 58235, Crestor
oral tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days
RosuvastatinDrug
Also called Crestor
oral tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days
PlaceboDrug
oral tablets; two ezetimibe placebo once daily for 14 days
EzetimibeDrug
Also called Zetia, SCH 58235
oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe + Rosuvastatin | Experimental | Not described Receives: Drug: Ezetimibe + Rosuvastatin |
| Ezetimibe | Active comparator | Not described Receives: Drug: Ezetimibe |
| Rosuvastatin | Active comparator | Not described Receives: Drug: Rosuvastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in total cholesterol, LDL-C, HDL-C, and triglycerides.
Measured: Day 15
Safety: adverse events, laboratory test results, physical examination, vital signs.
Measured: Throughout study
Secondary outcomes (1)
Evaluate potential for PK interaction between ezetimibe and rosuvastatin as indicated by Cmax and AUC.
Measured: Day 14
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 startMar 2003
- Primary completionMay 2003
- Study completionMay 2003
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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
- NCT00651144
- Sponsor's protocol ID
- P03317
- Status last verified
- Feb 2022
- First submitted
- 31 Mar 2008
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Kosoglou T, Statkevich P, Yang B, Suresh R, Zhu Y, Boutros T, Maxwell SE, Tiessen R, Cutler DL. Pharmacodynamic interaction between ezetimibe and rosuvastatin. Curr Med Res Opin. 2004 Aug;20(8):1185-95. doi: 10.1185/030079904125004213.
PubMed 15324521
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCH 058235: Assessment of a Multiple-Dose Drug Interaction Between Ezetimibe and Rosuvastatin in Healthy Hypercholesterolemic Subjects
- ClinicalTrials.gov ID
- NCT00651144
- Acronym / sponsor ID
- P03317
- Conditions
- Hypercholesterolemia, Atherosclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2003
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (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.
The purpose of this study is to obtain data of the coadministration of ezetimibe and rosuvastatin to support the concomitant use of these two drugs in patients requiring additional cholesterol-lowering management. Treatment is administered for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe + Rosuvastatin | Experimental | Drug: Ezetimibe + Rosuvastatin |
| Ezetimibe | Active comparator | Drug: Ezetimibe |
| Rosuvastatin | Active comparator | Drug: Rosuvastatin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males and females between the ages of 18 and 55 years inclusive, having a Body Mass Index (BMI) between 19-31 inclusive. BMI=weight (kg)/height (m^2).
- Subjects must have untreated hypercholesterolemia with a directly measured fasting LDL-C >=130 mg/dL (3.37 mmol/L) at Screening and on Day -1. Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.
- Subjects must have a normal or clinically acceptable physical exam and ECG (12-lead recorded at 25 mm/s and reporting heart rate and PR, QRS, QT, and QTc intervals).
- Subjects' clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/ sponsor.
- Screen for drugs with high potential for abuse must be negative.
Key exclusion criteria (14 listed)
- Female subjects who are pregnant, intend to become pregnant, or are nursing.
- Subjects who previously received or were treated with ezetimibe (SCH 58235) or rosuvastatin.
- Subjects who previously received or were treated with lipid lowering drugs (including OTC fish oil and phytosterols) within 6 weeks of Visit 1.
- Any subject who does not comply with the requirement that he/she should not have used any prescription or over-the-counter drugs (except for aspirin or acetaminophen [paracetamol]) within two weeks prior to study drug administration nor alcohol within 48 hours prior to study drug administration.
- Subjects who have used any investigational drugs or donated blood within 30 days of study entry.
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 + RosuvastatinAlso: Zetia, SCH 58235, Crestororal tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days | Drug | Ezetimibe + Rosuvastatin |
| RosuvastatinAlso: Crestororal tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days | Drug | Rosuvastatin |
| Placebooral tablets; two ezetimibe placebo once daily for 14 days | Drug | Placebo |
| EzetimibeAlso: Zetia, SCH 58235oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days | Drug | Ezetimibe |
Primary outcome
Percent change from baseline in total cholesterol, LDL-C, HDL-C, and triglycerides.
Time frame: Day 15
Safety: adverse events, laboratory test results, physical examination, vital signs.
Time frame: Throughout study
1 secondary outcome
Evaluate potential for PK interaction between ezetimibe and rosuvastatin as indicated by Cmax and AUC.
Time frame: Day 14
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 17 Feb 2022.
- Results publication: PubMed 15324521Kosoglou T, Statkevich P, Yang B, Suresh R, Zhu Y, Boutros T, Maxwell SE, Tiessen R, Cutler DL. Pharmacodynamic interaction between ezetimibe and rosuvastatin. Curr Med Res Opin. 2004 Aug;20(8):1185-95. doi: 10.1185/030079904125004213.
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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 1 study testing Ezetimibe + Rosuvastatin, Rosuvastatin and Ezetimibe in people with Hypercholesterolemia and Atherosclerosis, 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 9 inclusion and 14 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 17 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 total cholesterol, LDL-C, HDL-C, and triglycerides. (time frame: Day 15). 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 NCT00651144, 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 17 Feb 2022.