HypercholesterolemiaPhase 4NCT00651378
Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708)
A Phase 4 study testing Rosuvastatin, Ezetimibe + Atorvastatin and Double Atorvastatin in people with Hypercholesterolemia and Atherosclerosis, run by Organon and Co.
Trial summary
This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal LDL-cholesterol of <2.5 mmol/L. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia, Atherosclerosis, Coronary Artery Disease
- What is being tested?
- Rosuvastatin, Ezetimibe + Atorvastatin and Double Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2004to 1 Jun 2005
- Phase
- Phase 4
- 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
- 18 years to 75 years of age;
- Stabilized on atorvastatin 10 mg daily and by subject reported history had taken at least 80% of daily doses for the 4 weeks preceding Visit 1;
- LDL-C concentration greater than or equal to 2.5 mmol/L to less than or equal to 160 mg/dL (less than or equal to 4.1 mmol/L) based on blood specimens taken at Visit 1, using the Friedewald calculation as described in the Protocol,Section 8.8. (The lipid profiles at Visit 3 (baseline) and all subsequent visits were kept "blinded" until data analysis);
- Triglyceride concentration of less than 350 mg/dL (less than 3.99 mmol/L) based on blood specimens taken at Visit 1;
- Documented atherosclerotic disease, CHD, or diabetes mellitus;
- Liver transaminases (ALT, AST) less than 50% above the upper limit of normal, with no active liver disease, and CPK less than 50% above the upper limit of normal as tested in blood specimens taken at Visit 1;
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- Clinical laboratory tests (CBC, blood chemistries, urinalysis) taken at Visit 1 must have been within normal limits or clinically acceptable to the Investigator;
- Had been previously prescribed a cholesterol lowering diet and exercise program at least 4 weeks prior to Visit 1 and had been advised to continue the same diet and exercise program during the study;
- Reported a stable weight history for at least 4 weeks prior to randomization at Visit 3 (baseline visit);
- 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 willing to continue the same regimen for the duration of the study;
- Women of childbearing potential (included women who were less than 1 year postmenopausal and women who became sexually active) must have been using an acceptable method of birth control (for example, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or been surgically sterilized (for example, hysterectomy or tubal ligation).
- Free of any clinically significant diseases other than hyperlipidemia, CHD, or diabetes mellitus that would interfere with study evaluations;
- Understood and were able to adhere to the dosing and visit schedules, and demonstrated their willingness to participate in the study and comply with its procedures by signing a written informed consent.
Who cannot join
- Consumption greater than 14 alcoholic drinks per week. (A drink is: a can of beer [1/2 pint or 250 ml], glass of wine, or single measure of spirits);
- Any condition or situation which, in the opinion of the Investigator, might have posed a risk to the subject or interfered with participation in the study;
- Body mass index (BMI) >= 35 Kg/m^2 at Visit 2 (Screening);
- Women who were pregnant or nursing;
- Failure to observe the designated washout periods for any of the prohibited medications
About this study
Official title: An Open-Label, Randomized, Parallel-Group, Multicenter Study to Compare the Efficacy and Safety of "Switching" to Rosuvastatin 10 mg Daily Versus Atorvastatin 10 mg Daily With Ezetimibe 10 mg Daily Versus Doubling the Dose of Atorvastatin to 20 mg Daily in Subjects With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease or Diabetes Mellitus Who Have Not Achieved Study Target LDL-C Goal While Dosing With Atorvastatin 10 mg Daily
This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal LDL-cholesterol of <2.5 mmol/L. Treatment phase is 6 weeks.
- Being tested
- Rosuvastatin, Ezetimibe + Atorvastatin, Double Atorvastatin
- Medical subject headings
- Hypercholesterolemia, Atherosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
oral tablets: rosuvastatin 10 mg once daily for 6 weeks (switch from previous run-in with atorvastatin 10 mg daily)
Ezetimibe + AtorvastatinDrug
Also called SCH 58235, Zetia, Lipitor
oral tablets: ezetimibe 10 mg plus atorvastatin 10 mg once daily for 6 weeks (add ezetimibe to previous run-in with atorvastatin 10 mg daily)
Double AtorvastatinDrug
Also called Lipitor
oral tablets: atorvastatin 20 mg once daily for 6 weeks (double dose from previous run-in with atorvastatin 10 mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Not described Receives: Drug: Rosuvastatin |
| Ezetimibe + Atorvastatin | Active comparator | Not described Receives: Drug: Ezetimibe + Atorvastatin |
| Double Atorvastatin | Active comparator | Not described Receives: Drug: Double Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in LDL-C level from baseline to the study endpoint.
Measured: 6 weeks
Secondary outcomes (2)
Percent changes from baseline to the end of treatment in the concentrations of total cholesterol (TC), non-HDL-C, apo B, triglycerides (TG), HDL-C, LDL-C/HDL-C ratio, and TC/HDL-C ratio.
Measured: 6 weeks
Adverse events, laboratory test results, vital signs.
Measured: Throughout study
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 Sep 2004
- Primary completion1 Jun 2005
- Study completion1 Jun 2005
Why it stopped: Slow enrollment \[HIGH SCREEN FAILURE RATE\]
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 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
- NCT00651378
- Sponsor's protocol ID
- P03708
- 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
- An Open-Label, Randomized, Parallel-Group, Multicenter Study to Compare the Efficacy and Safety of "Switching" to Rosuvastatin 10 mg Daily Versus Atorvastatin 10 mg Daily With Ezetimibe 10 mg Daily Versus Doubling the Dose of Atorvastatin to 20 mg Daily in Subjects With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease or Diabetes Mellitus Who Have Not Achieved Study Target LDL-C Goal While Dosing With Atorvastatin 10 mg Daily
- ClinicalTrials.gov ID
- NCT00651378
- Acronym / sponsor ID
- P03708
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment \[HIGH SCREEN FAILURE RATE\]
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Sep 2004 (actual)
- Primary completion
- 1 Jun 2005 (actual)
- Study completion
- 1 Jun 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 study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal LDL-cholesterol of <2.5 mmol/L. Treatment phase is 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin |
| Ezetimibe + Atorvastatin | Active comparator | Drug: Ezetimibe + Atorvastatin |
| Double Atorvastatin | Active comparator | Drug: Double Atorvastatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years to 75 years of age;
- Stabilized on atorvastatin 10 mg daily and by subject reported history had taken at least 80% of daily doses for the 4 weeks preceding Visit 1;
- LDL-C concentration greater than or equal to 2.5 mmol/L to less than or equal to 160 mg/dL (less than or equal to 4.1 mmol/L) based on blood specimens taken at Visit 1, using the Friedewald calculation as described in the Protocol,Section 8.8. (The lipid profiles at Visit 3 (baseline) and all subsequent visits were kept "blinded" until data analysis);
- Triglyceride concentration of less than 350 mg/dL (less than 3.99 mmol/L) based on blood specimens taken at Visit 1;
- Documented atherosclerotic disease, CHD, or diabetes mellitus;
Key exclusion criteria (5 listed)
- Consumption greater than 14 alcoholic drinks per week. (A drink is: a can of beer [1/2 pint or 250 ml], glass of wine, or single measure of spirits);
- Any condition or situation which, in the opinion of the Investigator, might have posed a risk to the subject or interfered with participation in the study;
- Body mass index (BMI) >= 35 Kg/m^2 at Visit 2 (Screening);
- Women who were pregnant or nursing;
- Failure to observe the designated washout periods for any of the prohibited medications
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 |
|---|---|---|
| RosuvastatinAlso: Crestororal tablets: rosuvastatin 10 mg once daily for 6 weeks (switch from previous run-in with atorvastatin 10 mg daily) | Drug | Rosuvastatin |
| Ezetimibe + AtorvastatinAlso: SCH 58235, Zetia, Lipitororal tablets: ezetimibe 10 mg plus atorvastatin 10 mg once daily for 6 weeks (add ezetimibe to previous run-in with atorvastatin 10 mg daily) | Drug | Ezetimibe + Atorvastatin |
| Double AtorvastatinAlso: Lipitororal tablets: atorvastatin 20 mg once daily for 6 weeks (double dose from previous run-in with atorvastatin 10 mg daily) | Drug | Double Atorvastatin |
Primary outcome
Percent change in LDL-C level from baseline to the study endpoint.
Time frame: 6 weeks
2 secondary outcomes
Percent changes from baseline to the end of treatment in the concentrations of total cholesterol (TC), non-HDL-C, apo B, triglycerides (TG), HDL-C, LDL-C/HDL-C ratio, and TC/HDL-C ratio.
Time frame: 6 weeks
Adverse events, laboratory test results, vital signs.
Time frame: Throughout study
Results and safety
The study was stopped early (reason given: Slow enrollment \[HIGH SCREEN FAILURE RATE\]). Results are not available in the source record.
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 4 study testing Rosuvastatin, Ezetimibe + Atorvastatin and Double Atorvastatin 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 13 inclusion and 5 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: stopped early, 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 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?
The study was stopped early (reason given: Slow enrollment \[HIGH SCREEN FAILURE RATE\]). Results are not available in the source record.
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 in LDL-C level from baseline to the study endpoint. (time frame: 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 15 Aug 2024.