HypercholesterolemiaPhase 3GAUSS-4NCT02634580

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4

A Phase 3 study testing Evolocumab and Ezetimibe in people with Hypercholesterolemia, run by Amgen at 35 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: Evolocumab 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: 61 participants
Where: 35 sitesJapan
Study dates: 27 Feb 2016to 26 May 2018
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female ≥ 20 to ≤ 80 years of age
Japanese by self-identification
Not on a statin or on a low dose statin with stable dose for at least 4 weeks.
Subject not at LDL-C goal
History of statin intolerance to at least 2 statins
Lipid lowering therapy has been stable prior to screening 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

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

Japan35 sites

Research Site
Bunkyo-ku, Tokyo, 113-8655
Research Site
Chiba, Chiba, 260-8677
Research Site
Chikushino-shi, Fukuoka, 818-8516
Research Site
Chuo-ku, Tokyo, 103-0027
Research Site
Fujimi-shi, Saitama, 354-0031
Research Site
Hamamatsu, Shizuoka, 430-0929
Research Site
Higashiyamato-shi, Tokyo, 207-0014
Research Site
Hiroshima, Hiroshima, 734-8551
Research Site
Iruma-gun, Saitama, 350-0495
Research Site
Kagoshima, Kagoshima-ken, 890-8520
Research Site
Kahoku-gun, Ishikawa-ken, 920-0293
Research Site
Kanazawa, Ishikawa-ken, 920-8650
Research Site
Kawaguchi-shi, Saitama, 332-0012
Research Site
Kisarazu-shi, Chiba, 292-8535
Research Site
Kobe, Hyōgo, 650-0017
Research Site
Koga-shi, Fukuoka, 811-3195
Research Site
Koga-shi, Ibaraki, 306-0041
Research Site
Komatsu-shi, Ishikawa-ken, 923-8560
Research Site
Kumamoto, Kumamoto, 860-8556
Research Site
Kumamoto, Kumamoto, 862-0976
Research Site
Kyoto, Kyoto, 606-8507
Research Site
Matsudo-shi, Chiba, 271-0077
Research Site
Morioka, Iwate, 020-0866
Research Site
Morioka, Iwate, 020-8505
Research Site
Musashino-shi, Tokyo, 180-0022
Research Site
Nagoya, Aichi-ken, 466-8560
Research Site
Nagoya, Aichi-ken, 466-8650
Research Site
Nakagami-gun, Okinawa, 901-2393
Research Site
Ohsaki-shi, Miyagi, 989-6143
Research Site
Osaka, Osaka, 530-0001
Research Site
Osaka, Osaka, 553-0003
Research Site
Shinagawa-ku, Tokyo, 142-8666
Research Site
Sukagawa-shi, Fukushima, 962-0001
Research Site
Sukagawa-shi, Fukushima, 962-8503
Research Site
Yokohama, Kanagawa, 245-8575

Other trials in Japan

About this study

Official title: A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Japanese Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects

Read the detailed description

After screening participants who met all inclusion/exclusion criteria were randomized with an allocation ratio of 2:2:1:1 into 4 groups: evolocumab (AMG 145) 420 mg administered by subcutaneous injection monthly and placebo pill daily; evolocumab 140 mg administered by subcutaneous injection every two weeks and placebo pill by mouth daily; placebo 420 mg administered by subcutaneous injection monthly and ezetimibe 10 mg pill daily; placebo 140 mg administered subcutaneous injection every two weeks and ezetimibe 10 mg pill daily. Randomization was stratified by screening LDL-C level and baseline statin use. Participants on low or atypical statin dose therapy must have been on a stable dose for at least 4 weeks prior to screening and throughout the blinded portion of the study; the dose could not be adjusted during screening and for the duration of the study. After Week 12, ezetimibe was discontinued and participants moved to an open-label dose of evolocumab administered by subcutaneous injection either every two weeks or monthly and their standard of care.

Conditions: Hypercholesterolemia
Being tested: Evolocumab, Ezetimibe, Placebo to Evolocumab, Placebo Ezetimibe
Keywords: Japanese, High cholesterol, Treatment of high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia, Statin intolerant
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EvolocumabBiological
Also called AMG 145, Repatha
Administered by subcutaneous injection
EzetimibeDrug
Also called Zetia
Tablet for oral administration
Placebo to EvolocumabDrug
Administered by subcutaneous injection
Placebo EzetimibeDrug
Tablet for oral administration

Study groups in NCT02634580
Study group	Role	What they receive
Ezetimibe (Q2W)	Active comparator	Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks. From week 12 participants received open-label evolocumab 140 mg subcutaneously once every 2 weeks until week 48. Receives: Biological: Evolocumab; Drug: Ezetimibe; Drug: Placebo to Evolocumab
Ezetimibe (QM)	Active comparator	Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks. From week 12 participants received open-label evolocumab 420 mg subcutaneously once a month until week 48. Receives: Biological: Evolocumab; Drug: Ezetimibe; Drug: Placebo to Evolocumab
Evolocumab Q2W	Experimental	Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks. From week 12 participants received open-label evolocumab 140 mg subcutaneously once every 2 weeks until week 48. Receives: Biological: Evolocumab; Drug: Placebo Ezetimibe
Evolocumab QM	Experimental	Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks. From week 12 participants received open-label evolocumab 420 mg subcutaneously once a month until week 48. Receives: Biological: Evolocumab; Drug: Placebo Ezetimibe

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) at the Mean of Weeks 10 and 12
For all efficacy endpoints the two dosing regimens (every 2 weeks and every month) for each treatment were pooled for analysis.
Measured: Baseline and Weeks 10 and 12
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Measured: Baseline and week 12

Secondary outcomes (22)

Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Measured: Baseline and week 12
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Mean low density lipoprotein-cholesterol response was defined as LDL-C < 70 mg/dL [1.8 mol/L].
Measured: Weeks 10 and 12
Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12
Measured: Week 12
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Total Cholesterol at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Measured: Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in VLDL-C at Week 12
Measured: Baseline and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 201626 May 2018

First posted18 Dec 2015 (estimated)
Study start27 Feb 2016
Primary completion10 Aug 2017
Study completion26 May 2018

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.
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: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02634580
Sponsor's protocol ID: 20140234
Acronym: GAUSS-4
Status last verified: Oct 2020
First submitted: 16 Dec 2015
Last updated: 10 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Koba S, Inoue I, Cyrille M, Lu C, Inomata H, Shimauchi J, Kajinami K. Evolocumab vs. Ezetimibe in Statin-Intolerant Hyperlipidemic Japanese Patients: Phase 3 GAUSS-4 Trial. J Atheroscler Thromb. 2020 May 1;27(5):471-484. doi: 10.5551/jat.50963. Epub 2019 Nov 21.
PubMed 31748467

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2020. 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 Japanese Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects
ClinicalTrials.gov ID: NCT02634580
Acronym / sponsor ID: GAUSS-4 / 20140234
Conditions: Hypercholesterolemia
Keywords: Japanese, High cholesterol, Treatment of high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia, Statin intolerant
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 27 Feb 2016 (actual)
Primary completion: 10 Aug 2017 (actual)
Study completion: 26 May 2018 (actual)
First posted: 18 Dec 2015 (estimated)
Results: Posted 31 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Ezetimibe (Q2W)	Active comparator	Biological: Evolocumab, Drug: Ezetimibe, Drug: Placebo to EvolocumabParticipants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks. From week 12 participants received open-label evolocumab 140 mg subcutaneously once every 2 weeks until week 48.
Ezetimibe (QM)	Active comparator	Biological: Evolocumab, Drug: Ezetimibe, Drug: Placebo to EvolocumabParticipants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks. From week 12 participants received open-label evolocumab 420 mg subcutaneously once a month until week 48.
Evolocumab Q2W	Experimental	Biological: Evolocumab, Drug: Placebo EzetimibeParticipants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks. From week 12 participants received open-label evolocumab 140 mg subcutaneously once every 2 weeks until week 48.
Evolocumab QM	Experimental	Biological: Evolocumab, Drug: Placebo EzetimibeParticipants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks. From week 12 participants received open-label evolocumab 420 mg subcutaneously once a month until week 48.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female ≥ 20 to ≤ 80 years of age
Japanese by self-identification
Not on a statin or on a low dose statin with stable dose for at least 4 weeks.
Subject not at LDL-C goal
History of statin intolerance to at least 2 statins

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
EvolocumabAlso: AMG 145, RepathaAdministered by subcutaneous injection	Biological	Evolocumab Q2W, Evolocumab QM, Ezetimibe (Q2W), Ezetimibe (QM)
EzetimibeAlso: ZetiaTablet for oral administration	Drug	Ezetimibe (Q2W), Ezetimibe (QM)
Placebo to EvolocumabAdministered by subcutaneous injection	Drug	Ezetimibe (Q2W), Ezetimibe (QM)
Placebo EzetimibeTablet for oral administration	Drug	Evolocumab Q2W, Evolocumab QM

Primary outcome

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
For all efficacy endpoints the two dosing regimens (every 2 weeks and every month) for each treatment were pooled for analysis.
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and week 12

22 secondary outcomes

Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Time frame: Baseline and week 12
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Time frame: Weeks 10 and 12
Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12
Time frame: Week 12
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Total Cholesterol at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in VLDL-C at Week 12
Time frame: Baseline and week 12

Results and safety

Results posted to the registry on 31 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ezetimibe (Q2W)	10	9
Ezetimibe (QM)	11	11
Evolocumab Q2W	19	18
Evolocumab QM	21	20

Primary outcome: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12. Least squares mean (Standard Error). Unit: percent change

Measure	Ezetimibe n = 21	Evolocumab n = 40
Value	-20.39 (3.19)	-59.75 (2.30)

Ezetimibe vs Evolocumab: LS Mean Treatment Difference: -39.35 (95% CI -47.23 to -31.48), p <0.0001, Repeated measures linear effects model

Population analysed: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.

Primary outcome: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time frame: Baseline and week 12. Least squares mean (Standard Error). Unit: percent change

Measure	Ezetimibe n = 21	Evolocumab n = 40
Value	-19.13 (3.45)	-59.27 (2.50)

Ezetimibe vs Evolocumab: LS Mean Treatment Difference: -40.14 (95% CI -48.68 to -31.60), p < 0.0001, Repeated measures linear effects model

Population analysed: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Double-blind Treatment Period: From randomization (for all-cause mortality) or first dose of study drug (for adverse events) up to week 12 or the day before OLE day 1. Open-label Extension Period: From the start of the OLE (week 12) to end of study (week 54) for all-cause mortality (up to 42 weeks); and from first dose of study drug in the OLE up to 30 days after last dose, or end of study, whichever was earlier, for adverse events (a maximum of 40 weeks).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DB Period: Ezetimibe (Q2W)	1 of 10 (10%)	4 of 10 (40%)	0 of 10
DB Period: Ezetimibe (QM)	1 of 11 (9.1%)	8 of 11 (72.7%)	0 of 11
DB Period: Evolocumab Q2W	0 of 19 (0%)	11 of 19 (57.9%)	0 of 19
DB Period: Evolocumab QM	0 of 21 (0%)	12 of 21 (57.1%)	0 of 21
OLE Period: Evolocumab	4 of 58 (6.9%)	44 of 58 (75.9%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31748467Koba S, Inoue I, Cyrille M, Lu C, Inomata H, Shimauchi J, Kajinami K. Evolocumab vs. Ezetimibe in Statin-Intolerant Hyperlipidemic Japanese Patients: Phase 3 GAUSS-4 Trial. J Atheroscler Thromb. 2020 May 1;27(5):471-484. doi: 10.5551/jat.50963. Epub 2019 Nov 21.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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

35 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evolocumab and Ezetimibe in people with Hypercholesterolemia, run by Amgen at 35 sites in Japan.

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 7 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 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Japan. 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 31 Aug 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 Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 (time frame: Baseline and Weeks 10 and 12). 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 NCT02634580, 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 10 Nov 2020.