HypercholesterolemiaPhase 3NCT00766688
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia
A Phase 3 study testing AVE5530 in people with Hypercholesterolemia, run by Sanofi at 13 sites in 13 countries.
Trial summary
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- AVE5530
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 643 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Oct 2008to Jun 2009
- 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
- Adults with severe primary hypercholesterolemia and cholesterol levels not controlled on ongoing stable statin treatment at maximum doses.
Who cannot join
- LDL-C levels > 250 mg/dL (6.48 mmol/L) or < 100 mg/dL (2.59 mmol/L)
- Triglycerides >350 mg/dL (3.95 mmol/L)
- Conditions / situations such as:
- Presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels
- Active liver disease
- Recent history of congestive heart failure, of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease
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- Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody or Known to be Human Immunodeficient Virus (HIV) positive
- Pregnant or breast-feeding women,
- Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
Australia1 site
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AVE5530 When Added to Ongoing Stable Statin Therapy at High Doses in Patients With Severe Primary Hypercholesterolemia
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.
The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.
Read the detailed description
The two doses of AVE5530 tested in this study are 25 mg and 50 mg taken in the evening, with dinner dosing. The study will include a pre-randomization phase up to 6 weeks, a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.
- Conditions
- Hypercholesterolemia
- Being tested
- AVE5530, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVE5530Drug
- one tablet in the evening with dinner
- in addition to high doses of statin treatment
PlaceboDrug
- one tablet in the evening with dinner
- in addition to high doses of statin treatment
| Study group | Role | What they receive |
|---|---|---|
| 25 mg/day AVE5530 | Experimental | Not described Receives: Drug: AVE5530 |
| 50 mg/day AVE5530 | Experimental | Not described Receives: Drug: AVE5530 |
| Placebo | Placebo comparator | Not described 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 calculated LDL-C
Measured: At week 12
Secondary outcomes (2)
Percent change from baseline in calculated LDL-C
Measured: At 6 months and 12 months
Percent change from baseline in Total-Cholesterol and Apo-B
Measured: At 12 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2009
- Study completionJun 2009
Why it stopped: AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766688
- Sponsor's protocol ID
- EFC10841
- Other IDs
- EudraCT 2008-002849-23
- Status last verified
- Apr 2016
- First submitted
- 3 Oct 2008
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AVE5530 When Added to Ongoing Stable Statin Therapy at High Doses in Patients With Severe Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00766688
- Acronym / sponsor ID
- EFC10841
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy
- Enrolment
- 643 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Oct 2008 (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.
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.
The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.
Detailed description
The two doses of AVE5530 tested in this study are 25 mg and 50 mg taken in the evening, with dinner dosing. The study will include a pre-randomization phase up to 6 weeks, a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25 mg/day AVE5530 | Experimental | Drug: AVE5530 |
| 50 mg/day AVE5530 | Experimental | Drug: AVE5530 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with severe primary hypercholesterolemia and cholesterol levels not controlled on ongoing stable statin treatment at maximum doses.
Key exclusion criteria (10 listed)
- LDL-C levels > 250 mg/dL (6.48 mmol/L) or < 100 mg/dL (2.59 mmol/L)
- Triglycerides >350 mg/dL (3.95 mmol/L)
- Conditions / situations such as:
- Pregnant or breast-feeding women,
- Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product
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 |
|---|---|---|
| AVE5530* one tablet in the evening with dinner * in addition to high doses of statin treatment | Drug | 25 mg/day AVE5530, 50 mg/day AVE5530 |
| Placebo* one tablet in the evening with dinner * in addition to high doses of statin treatment | Drug | Placebo |
Primary outcome
Percent change from baseline in calculated LDL-C
Time frame: At week 12
2 secondary outcomes
Percent change from baseline in calculated LDL-C
Time frame: At 6 months and 12 months
Percent change from baseline in Total-Cholesterol and Apo-B
Time frame: At 12 weeks, 6 months and 12 months
Results and safety
The study was stopped early (reason given: AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
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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.
ICD CSD study director
Sanofi
13 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 AVE5530 in people with Hypercholesterolemia, run by Sanofi at 13 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 1 inclusion and 10 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: stopped early, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia, Belgium, Bulgaria, Canada 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. 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 stopped early (reason given: AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy). Results are not available in the source record.
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 calculated LDL-C (time frame: At week 12). 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 16 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.