Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular EventsPhase 3AMG145NCT01953328
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
A Phase 3 study testing Atorvastatin and Evolocumab in people with Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events, run by Amgen at 54 sites in Japan.
Trial summary
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events
- What is being tested?
- Atorvastatin and Evolocumab
- 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
- 409 participants
- Where
- 54 sitesJapan
- Study dates
- Oct 2013to Jun 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Male or female, Japanese adult, 20-85 years of age; Subjects on stable dose of statin for greater than equal to 4 weeks; Fasting LDL-C greater than equal to 100 mg/dL; Fasting triglycerides less than equal to 400 mg/dL; Subject is at high risk for cardiovascular events. Exclusion Criteria: 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
54 sites in 1 country.
54 sites in 1 country
Japan54 sites
Research Site
Akita, Akita, 010-1423
Research Site
Arakawa-ku, Tokyo, 116-0002
Research Site
Chiyoda-ku, Tokyo, 101-0024
Research Site
Chiyoda-ku, Tokyo, 101-0041
Research Site
Chofu-shi, Tokyo, 182-0006
Research Site
Chuo-ku, Tokyo, 103-0027
Research Site
Edogawa-ku, Tokyo, 133-0061
Research Site
Fukuoka, Fukuoka, 810-0014
Research Site
Fukuoka, Fukuoka, 810-0066
Research Site
Fukuoka, Fukuoka, 819-8551
Research Site
Hachioji-shi, Tokyo, 192-0046
Research Site
Hanamaki-shi, Iwate, 025-0075
Research Site
Ibaraki-shi, Osaka, 567-0876
Research Site
Itabashi-ku, Tokyo, 173-8610
Research Site
Katsushika-ku, Tokyo, 124-0024
Research Site
Kitakyusyu-shi, Fukuoka, 807-0856
Research Site
Koriyama-shi, Fukushima, 963-0209
Research Site
Koriyama-shi, Fukushima, 963-8026
Research Site
Koriyama-shi, Fukushima, 963-8041
Research Site
Koriyama-shi, Fukushima, 963-8832
Research Site
Koriyama-shi, Fukushima, 963-8862
Research Site
Koshigaya-shi, Saitama, 343-0826
Research Site
Koto-ku, Tokyo, 135-0011
Research Site
Kumagaya-shi, Saitama, 360-0816
Research Site
Kyoto, Kyoto, 615-8125
Research Site
Maebashi, Gunma, 371-0022
Research Site
Minato-ku, Tokyo, 105-7390
Research Site
Minato-ku, Tokyo, 108-0075
Research Site
Morioka, Iwate, 020-0066
Research Site
Niiza-shi, Saitama, 352-0014
Research Site
Noda, Chiba, 278-0004
Research Site
Osaka, Osaka, 530-0001
Research Site
Ōta-ku, Tokyo, 144-0034
Research Site
Sapporo, Hokkaido, 003-0026
Research Site
Sapporo, Hokkaido, 003-0825
Research Site
Sapporo, Hokkaido, 060-0063
Research Site
Sendai, Miyagi, 983-0039
Research Site
Sendai, Miyagi, 983-0835
Research Site
Sendai, Miyagi, 989-3122
Research Site
Setagaya-ku, Tokyo, 155-0031
Research Site
Shibuya-ku, Tokyo, 150-0012
Research Site
Shinagawa-ku, Tokyo, 140-0011
Research Site
Shinagawa-ku, Tokyo, 141-0001
Research Site
Shinagawa-ku, Tokyo, 141-6003
Research Site
Shinagawa-ku, Tokyo, 142-0053
Research Site
Takamatsu, Kagawa-ken, 760-0018
Research Site
Takamatsu, Kagawa-ken, 760-0076
Research Site
Takasaki-shi, Gunma, 370-3524
Research Site
Tomigusuku-shi, Okinawa, 901-0243
Research Site
Toshima-ku, Tokyo, 171-0021
Research Site
Toyonaka-shi, Osaka, 560-0082
Research Site
Tsuchiura-shi, Ibaraki, 300-0047
Research Site
Urasoe-shi, Okinawa, 901-2132
Research Site
Yokohama, Kanagawa, 231-0023
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) on LDL-C in Combination With Statin Therapy in Japanese Subjects With High Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.
Read the detailed description
After a screening and placebo run-in period, eligible patients were randomized in a 1:1 ratio to 1 of 2 open-label background statin treatments (atorvastatin 5 mg or 20 mg daily [QD]) and entered a 4-week lipid stabilization period. After the lipid stabilization period, eligible patients were randomized in a 1:1:1:1 ratio to investigational product (evolocumab or placebo) for the 12-week treatment period.
Both randomizations were stratified by subject diagnosis and lipid-lowering therapy as follows:
- current or prior diagnosis of heterozygous familial hypercholesterolemia (HeFH)
- no diagnosis of HeFH and receiving intensive lipid-lowering therapy
- no diagnosis of HeFH and receiving non-intensive lipid-lowering therapy. A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria including meeting final laboratory safety criteria, and undergoing both randomization procedures.
- Being tested
- Atorvastatin, Evolocumab, Placebo to Evolocumab
- Keywords
- Japanese, high cholesterol, LDL-C, High Cardiovascular Risk
- 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
Administered orally once a day
EvolocumabBiological
Also called AMG 145, Repatha
Administered by subcutaneous injection
Placebo to EvolocumabOther
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| A5 Placebo Q2W | Placebo comparator | Participants received atorvastatin 5 mg (A5) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. Receives: Drug: Atorvastatin; Other: Placebo to Evolocumab |
| A5 Placebo QM | Placebo comparator | Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. Receives: Drug: Atorvastatin; Other: Placebo to Evolocumab |
| A5 Evolocumab Q2W | Experimental | Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. Receives: Drug: Atorvastatin; Biological: Evolocumab |
| A5 Evolocumab QM | Experimental | Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. Receives: Drug: Atorvastatin; Biological: Evolocumab |
| A20 Placebo Q2W | Placebo comparator | Participants received atorvastatin 20 mg (A20) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks. Receives: Drug: Atorvastatin; Other: Placebo to Evolocumab |
| A20 Placebo QM | Other | Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks. Receives: Drug: Atorvastatin; Other: Placebo to Evolocumab |
| A20 Evolocumab Q2W | Experimental | Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. Receives: Drug: Atorvastatin; Biological: Evolocumab |
| A20 Evolocumab QM | Experimental | Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. Receives: Drug: Atorvastatin; Biological: Evolocumab |
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
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
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 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 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 the Apolipoprotein B/Apolipoprotein A-1 Ratio 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
Measured: Weeks 10 and 12
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
Measured: 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.
- First posted30 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJun 2014
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.
- Other trials for Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular EventsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 409 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
- NCT01953328
- Sponsor's protocol ID
- 20120122
- Acronym
- AMG145
- Status last verified
- Nov 2015
- First submitted
- 26 Sep 2013
- Last updated
- 23 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) on LDL-C in Combination With Statin Therapy in Japanese Subjects With High Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT01953328
- Acronym / sponsor ID
- AMG145 / 20120122
- Keywords
- Japanese, high cholesterol, LDL-C, High Cardiovascular Risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 23 Dec 2015
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 the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.
Detailed description
After a screening and placebo run-in period, eligible patients were randomized in a 1:1 ratio to 1 of 2 open-label background statin treatments (atorvastatin 5 mg or 20 mg daily [QD]) and entered a 4-week lipid stabilization period. After the lipid stabilization period, eligible patients were randomized in a 1:1:1:1 ratio to investigational product (evolocumab or placebo) for the 12-week treatment period.
Both randomizations were stratified by subject diagnosis and lipid-lowering therapy as follows:
- current or prior diagnosis of heterozygous familial hypercholesterolemia (HeFH)
- no diagnosis of HeFH and receiving intensive lipid-lowering therapy
- no diagnosis of HeFH and receiving non-intensive lipid-lowering therapy. A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria including meeting final laboratory safety criteria, and undergoing both randomization procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A5 Placebo Q2W | Placebo comparator | Drug: Atorvastatin, Other: Placebo to EvolocumabParticipants received atorvastatin 5 mg (A5) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. |
| A5 Placebo QM | Placebo comparator | Drug: Atorvastatin, Other: Placebo to EvolocumabParticipants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. |
| A5 Evolocumab Q2W | Experimental | Drug: Atorvastatin, Biological: EvolocumabParticipants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. |
| A5 Evolocumab QM | Experimental | Drug: Atorvastatin, Biological: EvolocumabParticipants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
| A20 Placebo Q2W | Placebo comparator | Drug: Atorvastatin, Other: Placebo to EvolocumabParticipants received atorvastatin 20 mg (A20) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks. |
| A20 Placebo QM | Other | Drug: Atorvastatin, Other: Placebo to EvolocumabParticipants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks. |
| A20 Evolocumab Q2W | Experimental | Drug: Atorvastatin, Biological: EvolocumabParticipants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. |
| A20 Evolocumab QM | Experimental | Drug: Atorvastatin, Biological: EvolocumabParticipants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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: LipitorAdministered orally once a day | Drug | A20 Evolocumab Q2W, A20 Evolocumab QM, A20 Placebo Q2W, A20 Placebo QM, A5 Evolocumab Q2W, A5 Evolocumab QM, A5 Placebo Q2W, A5 Placebo QM |
| EvolocumabAlso: AMG 145, RepathaAdministered by subcutaneous injection | Biological | A20 Evolocumab Q2W, A20 Evolocumab QM, A5 Evolocumab Q2W, A5 Evolocumab QM |
| Placebo to EvolocumabAdministered by subcutaneous injection | Other | A20 Placebo Q2W, A20 Placebo QM, A5 Placebo Q2W, A5 Placebo 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
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
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 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 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 the Apolipoprotein B/Apolipoprotein A-1 Ratio 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 LDL-C < 70 mg/dL at Week 12
Time frame: 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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
54 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 Atorvastatin and Evolocumab in people with Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events, run by Amgen at 54 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?
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 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 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. Some participants in this study may receive a placebo. 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 23 Dec 2015). 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?
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 23 Dec 2015; AzTrials last refreshed its copy on 30 Oct 2026.