HypercholesterolemiaPhase 3NCT00741715
Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia
A Phase 3 study testing AVE5530 and atorvastatin in people with Hypercholesterolemia, run by Sanofi at 2 sites in 2 countries.
Trial summary
The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. 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 and atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,736 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 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 high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy
Who cannot join
- LDL-C levels > 250 mg/dL (6.48 mmol/L)
- Triglycerides levels > 350mg/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
- High estimated risk of Coronary Heart Disease
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- Recent history of congestive heart failure , of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease
- 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
- Hypersensitivity to any component of atorvastatin
- Concurrent administration of Cytochrome P450 3A4 inhibitors (e.g. cyclosporine, erythromycin, clarithromycin, and azole antifungals) should be avoided as increasing the risk of myopathy with atorvastatin
- 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
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Multicenter, Randomized, Placebo-controlled, "Factorial" Design, 12-month Study to Evaluate the Efficacy and Safety of AVE5530 25 mg/Day and 50 mg/Day Co-administered With All Registered Atorvastatin Strengths Ranging From 10 mg to 80 mg in Patients With Primary Hypercholesterolemia
The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of the association AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives
Read the detailed description
The study will include a 2 week pre-randomization placebo lead-in phase. There will be a 12- week double-blind treatment period for both components AVE5530 and atorvastatin, followed by a 40-week period with maintenance of double-blind design for AVE5530 component and open label for atorvastatin component transitioning at 20 mg for all patients with subsequent titration, if necessary, based on regular LDL-cholesterol monitoring. The treatment period can be variably extended up to approximately 18 months with double-blind for AVE5530 component and open-label for atorvastatin.
- Conditions
- Hypercholesterolemia
- Being tested
- AVE5530, atorvastatin, placebo
- Keywords
- primary hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVE5530Drug
oral administration once daily in the evening with dinner
atorvastatinDrug
oral administration once daily in the evening with dinner
placeboDrug
oral administration once daily in the evening with dinner
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: placebo |
| 2 | Experimental | AVE5530 25mg Receives: Drug: AVE5530 |
| 3 | Experimental | AVE5530 50mg Receives: Drug: AVE5530 |
| 4 | Active comparator | atorvastatin 10mg Receives: Drug: atorvastatin |
| 5 | Experimental | atorvastatin 10mg + AVE5530 25mg Receives: Drug: AVE5530; Drug: atorvastatin |
| 6 | Experimental | atorvastatin 10mg + AVE5530 50mg Receives: Drug: AVE5530; Drug: atorvastatin |
| 7 | Active comparator | atorvastatin 20mg Receives: Drug: atorvastatin |
| 8 | Experimental | atorvastatin 20mg + AVE5530 25mg Receives: Drug: AVE5530; Drug: atorvastatin |
| 9 | Experimental | atorvastatin 20mg + AVE5530 50mg Receives: Drug: AVE5530; Drug: atorvastatin |
| 10 | Active comparator | atorvastatin 40mg Receives: Drug: atorvastatin |
| 11 | Experimental | atorvastatin 40mg + AVE5530 25mg Receives: Drug: AVE5530; Drug: atorvastatin |
| 12 | Experimental | atorvastatin 40mg + AVE5530 50mg Receives: Drug: AVE5530; Drug: atorvastatin |
| 13 | Active comparator | atorvastatin 80mg Receives: Drug: atorvastatin |
| 14 | Experimental | atorvastatin 80mg + AVE5530 25mg Receives: Drug: AVE5530; Drug: atorvastatin |
| 15 | Experimental | atorvastatin 80mg + AVE5530 50mg Receives: Drug: AVE5530; Drug: atorvastatin |
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, HDL-C, TG, Apo-A1, Apo-B and CRP
Measured: At week 12, 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 posted26 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMay 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,736 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Davidson Michael, MD, Principal investigator, Radiant Research - 515 North State Street Suite 2700 Chicago Illinois (US)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741715
- Sponsor's protocol ID
- EFC6911
- Status last verified
- Apr 2016
- First submitted
- 25 Aug 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, Randomized, Placebo-controlled, "Factorial" Design, 12-month Study to Evaluate the Efficacy and Safety of AVE5530 25 mg/Day and 50 mg/Day Co-administered With All Registered Atorvastatin Strengths Ranging From 10 mg to 80 mg in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00741715
- Acronym / sponsor ID
- EFC6911
- Conditions
- Hypercholesterolemia
- Keywords
- primary hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy
- Enrolment
- 1,736 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Aug 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 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of the association AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives
Detailed description
The study will include a 2 week pre-randomization placebo lead-in phase. There will be a 12- week double-blind treatment period for both components AVE5530 and atorvastatin, followed by a 40-week period with maintenance of double-blind design for AVE5530 component and open label for atorvastatin component transitioning at 20 mg for all patients with subsequent titration, if necessary, based on regular LDL-cholesterol monitoring. The treatment period can be variably extended up to approximately 18 months with double-blind for AVE5530 component and open-label for atorvastatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo |
| 2 | Experimental | Drug: AVE5530AVE5530 25mg |
| 3 | Experimental | Drug: AVE5530AVE5530 50mg |
| 4 | Active comparator | Drug: atorvastatinatorvastatin 10mg |
| 5 | Experimental | Drug: AVE5530, Drug: atorvastatinatorvastatin 10mg + AVE5530 25mg |
| 6 | Experimental | Drug: AVE5530, Drug: atorvastatinatorvastatin 10mg + AVE5530 50mg |
| 7 | Active comparator | Drug: atorvastatinatorvastatin 20mg |
| 8 | Experimental | Drug: AVE5530, Drug: atorvastatinatorvastatin 20mg + AVE5530 25mg |
| 9 | Experimental | Drug: AVE5530, Drug: atorvastatinatorvastatin 20mg + AVE5530 50mg |
| 10 | Active comparator | Drug: atorvastatinatorvastatin 40mg |
| 11 | Experimental | Drug: AVE5530, Drug: atorvastatinatorvastatin 40mg + AVE5530 25mg |
| 12 | Experimental | Drug: AVE5530, Drug: atorvastatinatorvastatin 40mg + AVE5530 50mg |
| 13 | Active comparator | Drug: atorvastatinatorvastatin 80mg |
| 14 | Experimental | Drug: AVE5530, Drug: atorvastatinatorvastatin 80mg + AVE5530 25mg |
| 15 | Experimental | Drug: AVE5530, Drug: atorvastatinatorvastatin 80mg + AVE5530 50mg |
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 high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy
Key exclusion criteria (13 listed)
- LDL-C levels > 250 mg/dL (6.48 mmol/L)
- Triglycerides levels > 350mg/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 |
|---|---|---|
| AVE5530oral administration once daily in the evening with dinner | Drug | 11, 12, 14, 15, 2, 3, 5, 6, 8, 9 |
| atorvastatinoral administration once daily in the evening with dinner | Drug | 10, 11, 12, 13, 14, 15, 4, 5, 6, 7, 8, 9 |
| placebooral administration once daily in the evening with dinner | Drug | 1 |
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, HDL-C, TG, Apo-A1, Apo-B and CRP
Time frame: At week 12, 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.
Davidson Michael, MD principal investigator
Radiant Research - 515 North State Street Suite 2700 Chicago Illinois (US)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AVE5530 and atorvastatin in people with Hypercholesterolemia, run by Sanofi at 2 sites in 2 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 13 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 2 sites in United States, Puerto Rico. 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.