HyperlipidemiaPhase 3GAUSS-3NCT01984424
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
A Phase 3 study testing Atorvastatin and Ezetimibe in people with Hyperlipidemia, run by Amgen at 58 sites in 13 countries.
Trial summary
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Atorvastatin and Ezetimibe
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 511 participants
- Where
- 58 sitesin 13 countries
- Study dates
- 10 Dec 2013to 21 Nov 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 to ≤ 80 years of age
- Subject not at LDL-C goal
- History of statin intolerance
- Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks
- Fasting triglycerides ≤ 400 mg/dL
Who cannot join
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes
- Poorly controlled type 2 diabetes
- Uncontrolled hypothyroidism or hyperthyroidism
Trial locations and contacts
58 sites in 13 countries.
58 sites in 13 countries
United States18 sites
Research Site
Ann Arbor, Michigan, 48106
Research Site
Atlanta, Georgia, 30322
Research Site
Baltimore, Maryland, 21201
Research Site
Beverly Hills, California, 90211
Research Site
Charleston, South Carolina, 29425
Research Site
Cleveland, Ohio, 44195
Research Site
Durham, North Carolina, 27710
Research Site
Houston, Texas, 77030
Research Site
Huntington Beach, California, 92648
Research Site
Kansas City, Kansas, 66160
Research Site
Los Angeles, California, 90048
Research Site
New York, New York, 10029
Research Site
Rochester, Minnesota, 55905
Research Site
San Pedro, California, 90732
Research Site
St Louis, Missouri, 63110
Research Site
Sterling, Illinois, 61081
Research Site
Towson, Maryland, 21204
Research Site
York, Pennsylvania, 17405
Canada7 sites
Research Site
Hamilton, Ontario, L8L 2X2
Research Site
London, Ontario, N6A 4V2
Research Site
Montreal, Quebec, H2W 1R7
Research Site
Peterborough, Ontario, K9J 0B2
Research Site
Québec, Quebec, G1V 4M6
Research Site
Saint-Charles-Borromée, Quebec, J6E 6J2
Research Site
Vancouver, British Columbia, V5Z 1M9
Italy6 sites
Research Site
Bologna, 40138
Research Site
Cagliari, 09134
Research Site
Cinisello Balsamo (MI), 20092
Research Site
Ferrara, 44100
Research Site
Perugia, 06129
Research Site
Pisa, 56124
South Africa4 sites
Research Site
Johannesburg, Gauteng, 2157
Research Site
Midrand, Gauteng, 1685
Research Site
Observatory, Western Cape, 7925
Research Site
Parow, Western Cape, 7505
Australia3 sites
Research Site
Ashford, South Australia, 5035
Research Site
Camperdown, New South Wales, 2015
Research Site
Woolloongabba, Queensland, 4102
Czechia3 sites
Research Site
Hradec Králové, 500 05
Research Site
Prague, 128 08
Research Site
Prague, 140 21
France3 sites
Research Site
Nantes, 44093
Research Site
Paris, 75651
Research Site
Vénissieux, 69200
Germany3 sites
Research Site
Berlin, 13353
Research Site
Cologne, 50937
Research Site
München, 80638
Netherlands3 sites
Research Site
Amsterdam, 1105 AZ
Research Site
Rotterdam, 3045 PM
Research Site
Zwijndrecht, 3331 LZ
United Kingdom3 sites
Research Site
Birmingham, B15 2TH
Research Site
Glasgow, G12 8TA
Research Site
Newcastle upon Tyne, NE1 4LP
Denmark2 sites
Research Site
Aarhus N, 8200
Research Site
Glostrup Municipality, 2600
About this study
Official title: A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).
Read the detailed description
The study is divided into 3 parts (A, B, C). After an initial 4-week washout period in which any statins, ezetimibe, or other lipid-lowering agents were discontinued, participants were enrolled in phase A, a double-blind, placebo-controlled crossover procedure to rechallenge patients with atorvastatin. Patients were randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg daily) or matching placebo for the first 10 weeks (period 1), then underwent a 2-week washout period, followed by crossover to the alternate therapy for a second 10-week period (period 2). Patients who experienced intolerable muscle symptoms during the first period did not complete the full 10 weeks of exposure but entered a 2-week washout period before proceeding to period 2.
Participants who did not develop muscle-related side effects were removed from the study, as were patients who reported muscle-related side effects during a placebo period.
After completion of phase A, patients who experienced muscle-related adverse effects while taking atorvastatin but not placebo were eligible for phase B, a 24-week, double-blind randomization to ezetimibe or evolocumab using a double-dummy design in which patients received either injectable placebo and oral ezetimibe or injectable evolocumab and oral placebo. A patient could proceed directly to phase B if they had a documented history of creatine kinase (CK) elevation more than 10 times the upper limit of normal accompanied by muscle symptoms while taking statin therapy, with documented resolution of both CK elevation and symptoms upon discontinuation of statin therapy.
These study procedures were designed to ensure that only patients with reproducible statin-associated muscle symptoms entered phase B of the study. For phase B, participants were randomized 2:1 to receive subcutaneously administered evolocumab (420 mg monthly) or oral ezetimibe (10 mg daily). Randomization in part B was stratified by screening LDL-C level (< 180 mg/dL [4.66 mmol/L] vs. ≥ 180 mg/dL) at study baseline.
Participants who completed phase B and did not discontinue SC investigational product for any reason, including an adverse event, were eligible to proceed to the 2-year open-label extension phase C to evaluate the long-term safety and efficacy of evolocumab in statin-intolerant patients. Participants in phase C were allowed to choose quarterly between evolocumab 420 mg SC QM or evolocumab 140 mg SC every 2 weeks (Q2W).
- Conditions
- Hyperlipidemia
- Being tested
- Atorvastatin, Placebo to Atorvastatin, Placebo to Ezetimibe, Ezetimibe, Placebo to Evolocumab
- Keywords
- High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
- Medical subject headings
- Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
Atorvastatin was supplied as over-encapsulated 20 mg tablets
Placebo to AtorvastatinDrug
Placebo matching to atorvastatin supplied as over-encapsulated tablets
Placebo to EzetimibeOther
Placebo matching to Ezetimibe supplied as over-encapsulated tablets.
EzetimibeDrug
Also called Zetia
Ezetimibe was supplied as 10 mg tablets, over-encapsulated for blinding.
Placebo to EvolocumabOther
Placebo matching to evolocumab supplied as single-use prefilled autoinjector/pen(s)
EvolocumabDrug
Also called Repatha
Evolocumab supplied as single-use prefilled autoinjector/pen(s)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Atorvastatin 20 mg => Placebo | Other | Participants received atorvastatin 20 mg orally for 10 weeks (period 1) followed by placebo orally for 10 weeks (period 2), separated by a 2-week washout period. Receives: Drug: Atorvastatin; Drug: Placebo to Atorvastatin |
| Part A: Placebo => Atorvastatin 20 mg | Other | Participants received placebo orally for 10 weeks (period 1) followed by atorvastatin 20 mg orally for 10 weeks (period 2), separated by a 2-week washout period. Receives: Drug: Atorvastatin; Drug: Placebo to Atorvastatin |
| Part B: Ezetimibe | Active comparator | Participants received 10 mg ezetimibe orally only a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks. Receives: Drug: Ezetimibe; Other: Placebo to Evolocumab |
| Part B: Evolocumab | Experimental | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks. Receives: Other: Placebo to Ezetimibe; Drug: Evolocumab |
| Part C: Open-label Evolocumab | Experimental | Participants who completed part B and were eligible to proceed to open-label extension part C and could choose quarterly between evolocumab 420 mg once a month or evolocumab 140 mg every 2 weeks for up to 2 years. Receives: Drug: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24
Measured: Baseline and weeks 22 and 24
Percent Change From Baseline in LDL-C at Week 24
Measured: Baseline and week 24
Secondary outcomes (22)
Change From Baseline in LDL-C at the Mean of Weeks 22 and 24
Measured: Baselie and weeks 22 and 24
Change From Baseline in LDL-C at Week 24
Measured: Baseline and week 24
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL
Measured: Weeks 22 and 24
Percentage of Participants Who Achieved LDL-C at Week 24 of Less Than 70 mg/dL
Measured: Week 24
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 22 and 24
Measured: Baseline and weeks 22 and 24
Percent Change From Baseline in Total Cholesterol at Week 24
Measured: Baseline and week 24
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 22 and 24
Measured: Baseline and weeks 22 and 24
Percent Change From Baseline in Non-HDL-C at Week 24
Measured: Baseline and week 24
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 22 and 24
Measured: Baseline and weeks 22 and 24
Percent Change From Baseline in Apolipoprotein B at Week 24
Measured: Baseline and week 24
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 22 and 24
Measured: Baseline and weeks 22 and 24
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 24
Measured: Baseline and week 24
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 22 and 24
Measured: Baseline and Weeks 22 and 24
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24
Measured: Baseline and week 24
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 22 and 24
Measured: Baseline and Weeks 22 and 24
Percent Change From Baseline in Lipoprotein(a) at Week 24
Measured: Baseline and week 24
Percent Change From Baseline in Triglycerides at the Mean of Weeks 22 and 24
Measured: Baseline and weeks 22 and 24
Percent Change From Baseline in Triglycerides at Week 24
Measured: Baseline and week 24
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 24
Measured: Baseline and weeks 22 and 24
Percent Change From Baseline in HDL-C at Week 24
Measured: Baseline and week 24
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 22 and 24
Measured: Baseline and weeks 22 and 24
Percent Change From Baseline in VLDL-C at Week 24
Measured: Baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study start10 Dec 2013
- Primary completion10 Nov 2015
- Study completion21 Nov 2017
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 (3)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984424
- Sponsor's protocol ID
- 20120332
- Other IDs
- 2013-000935-29
- Acronym
- GAUSS-3
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2013
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cho L, Dent R, Stroes ESG, Stein EA, Sullivan D, Ruzza A, Flower A, Somaratne R, Rosenson RS. Persistent Safety and Efficacy of Evolocumab in Patients with Statin Intolerance: a Subset Analysis of the OSLER Open-Label Extension Studies. Cardiovasc Drugs Ther. 2018 Aug;32(4):365-372. doi: 10.1007/s10557-018-6817-7.
PubMed 30073585Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
PubMed 33078867Nissen SE, Stroes E, Dent-Acosta RE, Rosenson RS, Lehman SJ, Sattar N, Preiss D, Bruckert E, Ceska R, Lepor N, Ballantyne CM, Gouni-Berthold I, Elliott M, Brennan DM, Wasserman SM, Somaratne R, Scott R, Stein EA; GAUSS-3 Investigators. Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1580-90. doi: 10.1001/jama.2016.3608.
PubMed 27039291
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects
- ClinicalTrials.gov ID
- NCT01984424
- Acronym / sponsor ID
- GAUSS-3 / 20120332
- Conditions
- Hyperlipidemia
- Keywords
- High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2013 (actual)
- Primary completion
- 10 Nov 2015 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).
Detailed description
The study is divided into 3 parts (A, B, C). After an initial 4-week washout period in which any statins, ezetimibe, or other lipid-lowering agents were discontinued, participants were enrolled in phase A, a double-blind, placebo-controlled crossover procedure to rechallenge patients with atorvastatin. Patients were randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg daily) or matching placebo for the first 10 weeks (period 1), then underwent a 2-week washout period, followed by crossover to the alternate therapy for a second 10-week period (period 2). Patients who experienced intolerable muscle symptoms during the first period did not complete the full 10 weeks of exposure but entered a 2-week washout period before proceeding to period 2.
Participants who did not develop muscle-related side effects were removed from the study, as were patients who reported muscle-related side effects during a placebo period.
After completion of phase A, patients who experienced muscle-related adverse effects while taking atorvastatin but not placebo were eligible for phase B, a 24-week, double-blind randomization to ezetimibe or evolocumab using a double-dummy design in which patients received either injectable placebo and oral ezetimibe or injectable evolocumab and oral placebo. A patient could proceed directly to phase B if they had a documented history of creatine kinase (CK) elevation more than 10 times the upper limit of normal accompanied by muscle symptoms while taking statin therapy, with documented resolution of both CK elevation and symptoms upon discontinuation of statin therapy.
These study procedures were designed to ensure that only patients with reproducible statin-associated muscle symptoms entered phase B of the study. For phase B, participants were randomized 2:1 to receive subcutaneously administered evolocumab (420 mg monthly) or oral ezetimibe (10 mg daily). Randomization in part B was stratified by screening LDL-C level (< 180 mg/dL [4.66 mmol/L] vs. ≥ 180 mg/dL) at study baseline.
Participants who completed phase B and did not discontinue SC investigational product for any reason, including an adverse event, were eligible to proceed to the 2-year open-label extension phase C to evaluate the long-term safety and efficacy of evolocumab in statin-intolerant patients. Participants in phase C were allowed to choose quarterly between evolocumab 420 mg SC QM or evolocumab 140 mg SC every 2 weeks (Q2W).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: Atorvastatin 20 mg => Placebo | Other | Drug: Atorvastatin, Drug: Placebo to AtorvastatinParticipants received atorvastatin 20 mg orally for 10 weeks (period 1) followed by placebo orally for 10 weeks (period 2), separated by a 2-week washout period. |
| Part A: Placebo => Atorvastatin 20 mg | Other | Drug: Atorvastatin, Drug: Placebo to AtorvastatinParticipants received placebo orally for 10 weeks (period 1) followed by atorvastatin 20 mg orally for 10 weeks (period 2), separated by a 2-week washout period. |
| Part B: Ezetimibe | Active comparator | Drug: Ezetimibe, Other: Placebo to EvolocumabParticipants received 10 mg ezetimibe orally only a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks. |
| Part B: Evolocumab | Experimental | Other: Placebo to Ezetimibe, Drug: EvolocumabParticipants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks. |
| Part C: Open-label Evolocumab | Experimental | Drug: EvolocumabParticipants who completed part B and were eligible to proceed to open-label extension part C and could choose quarterly between evolocumab 420 mg once a month or evolocumab 140 mg every 2 weeks for up to 2 years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥ 18 to ≤ 80 years of age
- Subject not at LDL-C goal
- History of statin intolerance
- Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks
- Fasting triglycerides ≤ 400 mg/dL
Key exclusion criteria (6 listed)
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes
- Poorly controlled type 2 diabetes
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 |
|---|---|---|
| AtorvastatinAlso: LipitorAtorvastatin was supplied as over-encapsulated 20 mg tablets | Drug | Part A: Atorvastatin 20 mg => Placebo, Part A: Placebo => Atorvastatin 20 mg |
| Placebo to AtorvastatinPlacebo matching to atorvastatin supplied as over-encapsulated tablets | Drug | Part A: Atorvastatin 20 mg => Placebo, Part A: Placebo => Atorvastatin 20 mg |
| Placebo to EzetimibePlacebo matching to Ezetimibe supplied as over-encapsulated tablets. | Other | Part B: Evolocumab |
| EzetimibeAlso: ZetiaEzetimibe was supplied as 10 mg tablets, over-encapsulated for blinding. | Drug | Part B: Ezetimibe |
| Placebo to EvolocumabPlacebo matching to evolocumab supplied as single-use prefilled autoinjector/pen(s) | Other | Part B: Ezetimibe |
| EvolocumabAlso: RepathaEvolocumab supplied as single-use prefilled autoinjector/pen(s) | Drug | Part B: Evolocumab, Part C: Open-label Evolocumab |
Primary outcome
Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24
Time frame: Baseline and weeks 22 and 24
Percent Change From Baseline in LDL-C at Week 24
Time frame: Baseline and week 24
22 secondary outcomes
Change From Baseline in LDL-C at the Mean of Weeks 22 and 24
Time frame: Baselie and weeks 22 and 24
Change From Baseline in LDL-C at Week 24
Time frame: Baseline and week 24
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL
Time frame: Weeks 22 and 24
Percentage of Participants Who Achieved LDL-C at Week 24 of Less Than 70 mg/dL
Time frame: Week 24
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 22 and 24
Time frame: Baseline and weeks 22 and 24
Percent Change From Baseline in Total Cholesterol at Week 24
Time frame: Baseline and week 24
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 22 and 24
Time frame: Baseline and weeks 22 and 24
Percent Change From Baseline in Non-HDL-C at Week 24
Time frame: Baseline and week 24
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 22 and 24
Time frame: Baseline and weeks 22 and 24
Percent Change From Baseline in Apolipoprotein B at Week 24
Time frame: Baseline and week 24
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 22 and 24
Time frame: Baseline and weeks 22 and 24
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 24
Time frame: Baseline and week 24
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 22 and 24
Time frame: Baseline and Weeks 22 and 24
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24
Time frame: Baseline and week 24
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 22 and 24
Time frame: Baseline and Weeks 22 and 24
Percent Change From Baseline in Lipoprotein(a) at Week 24
Time frame: Baseline and week 24
Percent Change From Baseline in Triglycerides at the Mean of Weeks 22 and 24
Time frame: Baseline and weeks 22 and 24
Percent Change From Baseline in Triglycerides at Week 24
Time frame: Baseline and week 24
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 24
Time frame: Baseline and weeks 22 and 24
Percent Change From Baseline in HDL-C at Week 24
Time frame: Baseline and week 24
Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 22 and 24
Time frame: Baseline and weeks 22 and 24
Percent Change From Baseline in VLDL-C at Week 24
Time frame: Baseline and week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30073585Cho L, Dent R, Stroes ESG, Stein EA, Sullivan D, Ruzza A, Flower A, Somaratne R, Rosenson RS. Persistent Safety and Efficacy of Evolocumab in Patients with Statin Intolerance: a Subset Analysis of the OSLER Open-Label Extension Studies. Cardiovasc Drugs Ther. 2018 Aug;32(4):365-372. doi: 10.1007/s10557-018-6817-7.
- Derived from this study: PubMed 33078867Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
- Derived from this study: PubMed 27039291Nissen SE, Stroes E, Dent-Acosta RE, Rosenson RS, Lehman SJ, Sattar N, Preiss D, Bruckert E, Ceska R, Lepor N, Ballantyne CM, Gouni-Berthold I, Elliott M, Brennan DM, Wasserman SM, Somaratne R, Scott R, Stein EA; GAUSS-3 Investigators. Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1580-90. doi: 10.1001/jama.2016.3608.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
58 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin and Ezetimibe in people with Hyperlipidemia, run by Amgen at 58 sites in 13 countries.
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 5 inclusion and 6 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 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Canada, Italy, South Africa, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 13 Mar 2018). 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-C at the Mean of Weeks 22 and 24 (time frame: Baseline and weeks 22 and 24). 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 NCT01984424, which also lists 3 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 29 Nov 2018.