HypercholesterolemiaPhase 3NCT00783263
A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
A Phase 3 study testing Comparator: rosuvastatin 5 mg + ezetimibe 10 mg, Comparator: rosuvastatin 10 mg and Comparator: rosuvastatin 10 mg + ezetimibe 10 mg in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III)… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Comparator: rosuvastatin 5 mg + ezetimibe 10 mg, Comparator: rosuvastatin 10 mg and Comparator: rosuvastatin 10 mg + ezetimibe 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to May 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive
- Participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for Coronary Heart Disease (CHD))
- Participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes Association(ADA) diet)
Who cannot join
- Participant weighs less than 100 lbs (45 kg).
- Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications.
- If female, participant is pregnant or breastfeeding.
- Participant consumes more than 2 alcoholic beverages per day.
- Participant has been in a clinical trial within the last 30 days.
- Participant has heart problems such as CHF, unstable angina or heart attack.
Show all 10Show fewer
- Participant has type 1 or 2 diabetes and has changed their medication in the last 2 months.
- Participant has liver disease.
- Participant is Human Immunodeficiency Virus (HIV) positive.
- Participant has a history of drug or alcohol abuse in the last year.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia at Risk for Coronary Heart Disease
A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal
- Conditions
- Hypercholesterolemia
- Being tested
- Comparator: rosuvastatin 5 mg + ezetimibe 10 mg, Comparator: rosuvastatin 10 mg, Comparator: rosuvastatin 10 mg + ezetimibe 10 mg, Comparator: rosuvastatin 20 mg
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: rosuvastatin 5 mg + ezetimibe 10 mgDrug
Also called Crestor, Zetia
Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
Comparator: rosuvastatin 10 mgDrug
Also called Crestor
Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
Comparator: rosuvastatin 10 mg + ezetimibe 10 mgDrug
Also called Crestor, Zetia
Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
Comparator: rosuvastatin 20 mgDrug
Also called Crestor
Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 5 mg + Ezetimibe 10 mg | Experimental | Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks. Receives: Drug: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg |
| Rosuvastatin 10 mg | Active comparator | Participants who received rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks. Receives: Drug: Comparator: rosuvastatin 10 mg |
| Rosuvastatin 10 mg + Ezetimibe 10 mg | Experimental | Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks. Receives: Drug: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg |
| Rosuvastatin 20 mg | Active comparator | Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks. Receives: Drug: Comparator: rosuvastatin 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment
The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
Measured: Baseline to 6 weeks
Secondary outcomes (6)
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum
The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
Measured: Baseline to 6 weeks
Number of Participants Who Reached Their Target LDL-C Level
Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.
Measured: 6 weeks of treatment
Number of Participants in Each Stratum Who Reached Their Target LDL-C Level
Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.
Measured: 6 weeks of treatment
Number of Participants Who Reached the LDL-C Level of <70 mg/dl
Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
Measured: 6 weeks of treatment
Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl
Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).
Measured: 6 weeks of treatment
Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels
Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783263
- Sponsor's protocol ID
- 0653-139
- Other IDs
- 2008_567
- Status last verified
- Feb 2022
- First submitted
- 30 Oct 2008
- Last updated
- 14 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bays HE, Davidson MH, Massaad R, Flaim D, Lowe RS, Tershakovec AM, Jones-Burton C. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011 Aug 15;108(4):523-30. doi: 10.1016/j.amjcard.2011.03.079. Epub 2011 May 17.
PubMed 21596364
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia at Risk for Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00783263
- Acronym / sponsor ID
- 0653-139
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Posted 14 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 5 mg + Ezetimibe 10 mg | Experimental | Drug: Comparator: rosuvastatin 5 mg + ezetimibe 10 mgParticipants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks. |
| Rosuvastatin 10 mg | Active comparator | Drug: Comparator: rosuvastatin 10 mgParticipants who received rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks. |
| Rosuvastatin 10 mg + Ezetimibe 10 mg | Experimental | Drug: Comparator: rosuvastatin 10 mg + ezetimibe 10 mgParticipants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks. |
| Rosuvastatin 20 mg | Active comparator | Drug: Comparator: rosuvastatin 20 mgParticipants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive
- Participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for Coronary Heart Disease (CHD))
- Participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes Association(ADA) diet)
Key exclusion criteria (10 listed)
- Participant weighs less than 100 lbs (45 kg).
- Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications.
- If female, participant is pregnant or breastfeeding.
- Participant consumes more than 2 alcoholic beverages per day.
- Participant has been in a clinical trial within the last 30 days.
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 |
|---|---|---|
| Comparator: rosuvastatin 5 mg + ezetimibe 10 mgAlso: Crestor, ZetiaParticipants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks. | Drug | Rosuvastatin 5 mg + Ezetimibe 10 mg |
| Comparator: rosuvastatin 10 mgAlso: CrestorParticipants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks. | Drug | Rosuvastatin 10 mg |
| Comparator: rosuvastatin 10 mg + ezetimibe 10 mgAlso: Crestor, ZetiaParticipants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks. | Drug | Rosuvastatin 10 mg + Ezetimibe 10 mg |
| Comparator: rosuvastatin 20 mgAlso: CrestorParticipants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks. | Drug | Rosuvastatin 20 mg |
Primary outcome
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment
Time frame: Baseline to 6 weeks
The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
6 secondary outcomes
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum
Time frame: Baseline to 6 weeks
Number of Participants Who Reached Their Target LDL-C Level
Time frame: 6 weeks of treatment
Number of Participants in Each Stratum Who Reached Their Target LDL-C Level
Time frame: 6 weeks of treatment
Number of Participants Who Reached the LDL-C Level of <70 mg/dl
Time frame: 6 weeks of treatment
Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl
Time frame: 6 weeks of treatment
Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels
Time frame: Baseline to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21596364Bays HE, Davidson MH, Massaad R, Flaim D, Lowe RS, Tershakovec AM, Jones-Burton C. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011 Aug 15;108(4):523-30. doi: 10.1016/j.amjcard.2011.03.079. Epub 2011 May 17.
- 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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Comparator: rosuvastatin 5 mg + ezetimibe 10 mg, Comparator: rosuvastatin 10 mg and Comparator: rosuvastatin 10 mg + ezetimibe 10 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 3 inclusion and 10 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 14 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. 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?
Yes. Results are posted in the registry (first posted 14 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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-Cholesterol (mg/dL) After 6 Weeks of Treatment (time frame: Baseline to 6 weeks). 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 NCT00783263, 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 14 May 2024.