Primary Hyperlipidemia or Mixed DyslipidemiaPhase 3SPIRE-ASIANCT02947334
Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects
A Phase 3 study testing Bococizumab in people with Primary Hyperlipidemia or Mixed Dyslipidemia, run by Pfizer at 1 site in China.
Trial summary
This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab 150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperlipidemia or Mixed Dyslipidemia
- What is being tested?
- Bococizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2016to 3 May 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females at the age or over 18 years of age.
- With primary hyperlipidemia or mixed dyslipidemia.
- Treated with stable daily dose of statins
- At high or very high risk of incurring a CV event
- Fasting LDL-C >=70 mg/dL (1.81 mmol/L) for subjects on the highest approved dose of statins; Fasting LDL C >=77 mg/dL (1.99 mmol/L) for subjects not on highest approved dose.
- Fasting TG ≤400 mg/dL (4.51 mmol/L)
Who cannot join
- Prior exposure to bococizumab or other investigational PCSK9 inhibitor
- NYHA class IV, or Left Ventricular Ejection Fraction <25%
- Poorly controlled hypertension
- History of hemorrhagic stroke or lacunar infarction resulting in a stroke
- Untreated hyperthyroidism or TSH >1 × ULN
- Undergoing apheresis or have planned start of apheresis.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
About this study
Official title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Bococizumab (Pf-04950615) In Asian Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab 150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk for CV events. The study will enroll a total of approximately 750 subjects from 4 - 5 Asian countries/areas (including China mainland); of which approximately 600 subjects will be from sites in China. Subjects will be randomized into a bococizumab treatment arm and a placebo arm in a 1:1 ratio.
Read the detailed description
After providing consent, subjects will enter a screening period of approximately 28 days to verify eligibility for the trial. Eligible subjects will be considered enrolled and progress to the Randomization visit. Results from screening evaluations will be reviewed and only subjects who continue to meet all eligibility criteria will be randomized. Randomized subjects will enter the 12-week treatment period, followed by a 40-week long-term treatment period and a 6 week follow-up, for a total of 58 weeks (approximately 14 months) study participation. Subjects will attend clinic visits as shown in the Schedule of Activities. Subjects will be randomized to receive either 150 mg Q2wks of bococizumab or placebo in a 1:1 ratio. Lipid levels will be blinded to the investigator and staff, subject and sponsor.
- Being tested
- Bococizumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BococizumabBiological
Also called RN316
Bococizumab PFS
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Bococizumab | Experimental | Bococizumab Q2wks Receives: Biological: Bococizumab |
| Placebo | Placebo comparator | Bococizumab placebo Q2wks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Percent change from baseline in fasting LDL-C
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start31 Oct 2016 (estimated)
- Primary completion3 May 2019 (estimated)
- Study completion3 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Hyperlipidemia or Mixed DyslipidemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947334
- Sponsor's protocol ID
- B1481047
- Acronym
- SPIRE-ASIA
- Status last verified
- Nov 2017
- First submitted
- 26 Oct 2016
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Bococizumab (Pf-04950615) In Asian Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
- ClinicalTrials.gov ID
- NCT02947334
- Acronym / sponsor ID
- SPIRE-ASIA / B1481047
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2016 (estimated)
- Primary completion
- 3 May 2019 (estimated)
- Study completion
- 3 May 2019 (estimated)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab 150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk for CV events. The study will enroll a total of approximately 750 subjects from 4 - 5 Asian countries/areas (including China mainland); of which approximately 600 subjects will be from sites in China. Subjects will be randomized into a bococizumab treatment arm and a placebo arm in a 1:1 ratio.
Detailed description
After providing consent, subjects will enter a screening period of approximately 28 days to verify eligibility for the trial. Eligible subjects will be considered enrolled and progress to the Randomization visit. Results from screening evaluations will be reviewed and only subjects who continue to meet all eligibility criteria will be randomized. Randomized subjects will enter the 12-week treatment period, followed by a 40-week long-term treatment period and a 6 week follow-up, for a total of 58 weeks (approximately 14 months) study participation. Subjects will attend clinic visits as shown in the Schedule of Activities. Subjects will be randomized to receive either 150 mg Q2wks of bococizumab or placebo in a 1:1 ratio. Lipid levels will be blinded to the investigator and staff, subject and sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bococizumab | Experimental | Biological: BococizumabBococizumab Q2wks |
| Placebo | Placebo comparator | Drug: PlaceboBococizumab placebo Q2wks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females at the age or over 18 years of age.
- With primary hyperlipidemia or mixed dyslipidemia.
- Treated with stable daily dose of statins
- At high or very high risk of incurring a CV event
- Fasting LDL-C >=70 mg/dL (1.81 mmol/L) for subjects on the highest approved dose of statins; Fasting LDL C >=77 mg/dL (1.99 mmol/L) for subjects not on highest approved dose.
Key exclusion criteria (6 listed)
- Prior exposure to bococizumab or other investigational PCSK9 inhibitor
- NYHA class IV, or Left Ventricular Ejection Fraction <25%
- Poorly controlled hypertension
- History of hemorrhagic stroke or lacunar infarction resulting in a stroke
- Untreated hyperthyroidism or TSH >1 × ULN
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 |
|---|---|---|
| BococizumabAlso: RN316Bococizumab PFS | Biological | Bococizumab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
• Percent change from baseline in fasting LDL-C
Time frame: 12weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Related trials for Primary Hyperlipidemia or Mixed Dyslipidemia
Active, not recruitingObservational study
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
Hypercholesterolemia, Mixed Dyslipidemia
RecruitingPhase 3
Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
Mixed Dyslipidemia, Hypercholesterolaemia
RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia
Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
Not yet recruitingPhase 3
QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Not yet recruitingPhase 3
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
Primary Hypercholesterolemia or Mixed Hyperlipidemia
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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bococizumab in people with Primary Hyperlipidemia or Mixed Dyslipidemia, run by Pfizer at 1 site in China.
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 6 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: withdrawn, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 fasting LDL-C (time frame: 12weeks). 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 2 Dec 2017.