HypercholesterolemiaPhase 3NCT01154036
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
A Phase 3 study testing ezetimibe 10 mg, atorvastatin and Comparator: rosuvastatin in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C)… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- ezetimibe 10 mg, atorvastatin and Comparator: rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,547 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Oct 2012
- 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
- Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
- Patient is willing to maintain a cholesterol lowering diet during the study
- Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study
Who cannot join
- Patient is Asian
- Patient routinely has more than 2 alcoholic drinks per day
- Female patient is pregnant or breastfeeding
- Patient has congestive heart failure
- Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
- Patient has uncontrolled cardiac arrhythmias
Show all 14Show fewer
- Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
- Patient has uncontrolled high blood pressure
- Patient has kidney disease
- Patient has any disease known to influence blood lipid levels
- Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
- Patient has poorly controlled or newly diagnosed diabetes
- Patient is known to be HIV positive
- Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers
About this study
Official title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled With Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
Read the detailed description
This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases; each 6 weeks in duration). Only those participants who do not meet low density lipoprotein-cholesterol (LDL-C) goals at the end of Phase I (Week 6), were eligible to continue into Phase II (Week 12).
- Conditions
- Hypercholesterolemia
- Being tested
- ezetimibe 10 mg, atorvastatin, Comparator: rosuvastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ezetimibe 10 mgDrug
atorvastatinDrug
Comparator: rosuvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Phase I: ezetimibe (EZ) 10 mg + atorvastatin (Atorva) 10 mg | Experimental | Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks Receives: Drug: ezetimibe 10 mg; Drug: atorvastatin |
| Phase I: Atorvastatin 20 mg | Active comparator | Atorvastatin 20 mg tablet once daily for 6 weeks Receives: Drug: atorvastatin |
| Phase I: Rosuvastatin 10 mg | Active comparator | Rosuvastatin 10 mg tablet once daily for 6 weeks Receives: Drug: Comparator: rosuvastatin |
| Phase II: EZ 10mg+Atorva 10mg | Experimental | Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I Receives: Drug: ezetimibe 10 mg; Drug: atorvastatin |
| Phase II: EZ 10mg + Atorva 20mg [A] | Experimental | Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II Receives: Drug: ezetimibe 10 mg; Drug: atorvastatin |
| Phase II: Atorva 40mg | Active comparator | Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II Receives: Drug: atorvastatin |
| Phase II: EZ 10mg + Atorva 20mg [R] | Experimental | Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II Receives: Drug: ezetimibe 10 mg; Drug: atorvastatin |
| Phase II: Rosuvastatin 20mg | Active comparator | Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase Receives: Drug: Comparator: rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)
LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).
Measured: Baseline and Week 6 (end of Phase I )
Secondary outcomes (27)
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).
LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).
Measured: Baseline (Week 6) and Week 12
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)
Measured: Week 6 (End of Phase I)
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)
Measured: Week 12 (End of Phase II)
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)
Measured: Week 6 (End of Phase I)
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)
Measured: Week 12 (end of Phase II)
Percent Change From Baseline in Total Cholesterol (TC) (Phase I)
TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Total Cholesterol (TC) (Phase II)
TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Measured: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in Triglycerides (TG) (Phase I)
TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Triglycerides (TG) (Phase II)
TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Measured: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)
HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in HDL-C (Phase II)
HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Measured: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)
Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Apo B (Phase II)
Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Measured: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)
Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Apo A-I (Phase II)
Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Measured: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in Non-HDL-C (Phase I)
Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Non-HDL-C (Phase II)
Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Measured: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in TC/HDL-C Ratio (Phase I)
TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in TC/HDL-C Ratio (Phase II)
TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Measured: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)
LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)
LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Measured: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)
Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)
Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Measured: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)
Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)
Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.
Measured: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)
hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Measured: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Hs-CRP (Phase II)
hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.
Measured: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionOct 2012
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 (2)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
- 1,547 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
- NCT01154036
- Sponsor's protocol ID
- 0653C-162
- Other IDs
- 2010_517
- Status last verified
- Feb 2022
- First submitted
- 29 Jun 2010
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Krempf M, Simpson RJ Jr, Ramey DR, Brudi P, Giezek H, Tomassini JE, Lee R, Farnier M. Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey. Lipids Health Dis. 2015 May 19;14:45. doi: 10.1186/s12944-015-0037-y.
PubMed 25985907Bays HE, Averna M, Majul C, Muller-Wieland D, De Pellegrin A, Giezek H, Lee R, Lowe RS, Brudi P, Triscari J, Farnier M. Efficacy and safety of ezetimibe added to atorvastatin versus atorvastatin uptitration or switching to rosuvastatin in patients with primary hypercholesterolemia. Am J Cardiol. 2013 Dec 15;112(12):1885-95. doi: 10.1016/j.amjcard.2013.08.031. Epub 2013 Sep 21.
PubMed 24063830
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled With Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin
- ClinicalTrials.gov ID
- NCT01154036
- Acronym / sponsor ID
- 0653C-162
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,547 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Posted 12 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
Detailed description
This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases; each 6 weeks in duration). Only those participants who do not meet low density lipoprotein-cholesterol (LDL-C) goals at the end of Phase I (Week 6), were eligible to continue into Phase II (Week 12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Phase I: ezetimibe (EZ) 10 mg + atorvastatin (Atorva) 10 mg | Experimental | Drug: ezetimibe 10 mg, Drug: atorvastatinCo-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks |
| Phase I: Atorvastatin 20 mg | Active comparator | Drug: atorvastatinAtorvastatin 20 mg tablet once daily for 6 weeks |
| Phase I: Rosuvastatin 10 mg | Active comparator | Drug: Comparator: rosuvastatinRosuvastatin 10 mg tablet once daily for 6 weeks |
| Phase II: EZ 10mg+Atorva 10mg | Experimental | Drug: ezetimibe 10 mg, Drug: atorvastatinParticipants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I |
| Phase II: EZ 10mg + Atorva 20mg [A] | Experimental | Drug: ezetimibe 10 mg, Drug: atorvastatinParticipants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II |
| Phase II: Atorva 40mg | Active comparator | Drug: atorvastatinParticipants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II |
| Phase II: EZ 10mg + Atorva 20mg [R] | Experimental | Drug: ezetimibe 10 mg, Drug: atorvastatinParticipants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II |
| Phase II: Rosuvastatin 20mg | Active comparator | Drug: Comparator: rosuvastatinParticipants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
- Patient is willing to maintain a cholesterol lowering diet during the study
- Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study
Key exclusion criteria (14 listed)
- Patient is Asian
- Patient routinely has more than 2 alcoholic drinks per day
- Female patient is pregnant or breastfeeding
- Patient has congestive heart failure
- Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
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 10 mg | Drug | Phase I: ezetimibe (EZ) 10 mg + atorvastatin (Atorva) 10 mg, Phase II: EZ 10mg + Atorva 20mg [A], Phase II: EZ 10mg + Atorva 20mg [R], Phase II: EZ 10mg+Atorva 10mg |
| atorvastatin | Drug | Phase I: Atorvastatin 20 mg, Phase I: ezetimibe (EZ) 10 mg + atorvastatin (Atorva) 10 mg, Phase II: Atorva 40mg, Phase II: EZ 10mg + Atorva 20mg [A], Phase II: EZ 10mg + Atorva 20mg [R], Phase II: EZ 10mg+Atorva 10mg |
| Comparator: rosuvastatin | Drug | Phase I: Rosuvastatin 10 mg, Phase II: Rosuvastatin 20mg |
Primary outcome
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)
Time frame: Baseline and Week 6 (end of Phase I )
LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).
27 secondary outcomes
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).
Time frame: Baseline (Week 6) and Week 12
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)
Time frame: Week 6 (End of Phase I)
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)
Time frame: Week 12 (End of Phase II)
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)
Time frame: Week 6 (End of Phase I)
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)
Time frame: Week 12 (end of Phase II)
Percent Change From Baseline in Total Cholesterol (TC) (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Total Cholesterol (TC) (Phase II)
Time frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in Triglycerides (TG) (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Triglycerides (TG) (Phase II)
Time frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in HDL-C (Phase II)
Time frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Apo B (Phase II)
Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Apo A-I (Phase II)
Time frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in Non-HDL-C (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Non-HDL-C (Phase II)
Time frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
Percent Change From Baseline in TC/HDL-C Ratio (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in TC/HDL-C Ratio (Phase II)
Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)
Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)
Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)
Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)
Time frame: Baseline and Week 6 (end of Phase I)
Percent Change From Baseline in Hs-CRP (Phase II)
Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25985907Krempf M, Simpson RJ Jr, Ramey DR, Brudi P, Giezek H, Tomassini JE, Lee R, Farnier M. Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey. Lipids Health Dis. 2015 May 19;14:45. doi: 10.1186/s12944-015-0037-y.
- Derived from this study: PubMed 24063830Bays HE, Averna M, Majul C, Muller-Wieland D, De Pellegrin A, Giezek H, Lee R, Lowe RS, Brudi P, Triscari J, Farnier M. Efficacy and safety of ezetimibe added to atorvastatin versus atorvastatin uptitration or switching to rosuvastatin in patients with primary hypercholesterolemia. Am J Cardiol. 2013 Dec 15;112(12):1885-95. doi: 10.1016/j.amjcard.2013.08.031. Epub 2013 Sep 21.
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Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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 ezetimibe 10 mg, atorvastatin and Comparator: rosuvastatin 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 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 9 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. 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 12 Feb 2014). 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 Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) (time frame: Baseline and Week 6 (end of Phase I )). 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 NCT01154036, 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 9 Feb 2022.