HypercholesterolemiaPhase 2NCT00440154
A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia
A Phase 2 study testing AVE5530 and ezetimibe in people with Hypercholesterolemia, run by Sanofi at 6 sites in 6 countries.
Trial summary
The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma levels and the safety and tolerability of AVE5530. 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 ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Feb 2007to Oct 2007
- Phase
- Phase 2
- 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
- Patients with mild to moderate primary hypercholesterolemia with stabilized LDL-C baseline ≥130 mg/dL and ≤ 250 mg/dL (≥ 3.36 mmol/L and ≤ 6.46 mmol/L)
- Male aged ≥ 18 years or postmenopausal women at screening
Who cannot join
- Presence of any clinically significant endocrine disease known to influence serum lipids or lipoproteins
- Patients with type 1 diabetes
- Presence or history of cancer within the past five years
- Triglycerides ≥ 300 mg/dL (3.39 mmol/L)
- Fasting plasma glucose > 160 mg/dL (8.9 mmol/L)
- Impaired kidney function and active liver disease
Show all 9Show fewer
- Within one month prior to screening visit and/or at the time or after the screening visit, administration of any lipid lowering treatment
- Creatine Kinase > 2xUpper Limit of Normal range
- 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
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,Ezetimibe-Calibrated, Multicenter Study Evaluating the Safety and Efficacy of Four Doses and Two Dose-Regimens of AVE5530 Over 4 Weeks in Patients With Mild to Moderate Primary Hypercholesterolemia
The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma levels and the safety and tolerability of AVE5530.
- Conditions
- Hypercholesterolemia
- Being tested
- AVE5530, placebo, ezetimibe
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVE5530Drug
placeboDrug
ezetimibeDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | oral administration 5 mg breakfast timing Receives: Drug: AVE5530 |
| 2 | Experimental | oral administration 25 mg breakfast timing Receives: Drug: AVE5530 |
| 3 | Experimental | oral administration 50 mg breakfast timing Receives: Drug: AVE5530 |
| 4 | Experimental | oral administration 100 mg breakfast timing Receives: Drug: AVE5530 |
| 5 | Experimental | oral administration 25 mg dinner timing Receives: Drug: AVE5530 |
| 6 | Placebo comparator | oral administration Receives: Drug: placebo |
| 7 | Active comparator | oral administration 10mg breakfast timing Receives: Drug: ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in LDL-C from baseline
Measured: 4 weeks
Secondary outcomes (2)
Absolute change from in LDL-C levels
Measured: 4 weeks
Percent change in other lipids and lipoprotein fractions from baseline
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2007
- Study completionOct 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440154
- Sponsor's protocol ID
- DRI6589
- Other IDs
- EudraCT: 2006-005469-20
- Status last verified
- Dec 2008
- First submitted
- 23 Feb 2007
- Last updated
- 16 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,Ezetimibe-Calibrated, Multicenter Study Evaluating the Safety and Efficacy of Four Doses and Two Dose-Regimens of AVE5530 Over 4 Weeks in Patients With Mild to Moderate Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00440154
- Acronym / sponsor ID
- DRI6589
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 26 Feb 2007 (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 primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma levels and the safety and tolerability of AVE5530.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AVE5530oral administration 5 mg breakfast timing |
| 2 | Experimental | Drug: AVE5530oral administration 25 mg breakfast timing |
| 3 | Experimental | Drug: AVE5530oral administration 50 mg breakfast timing |
| 4 | Experimental | Drug: AVE5530oral administration 100 mg breakfast timing |
| 5 | Experimental | Drug: AVE5530oral administration 25 mg dinner timing |
| 6 | Placebo comparator | Drug: placebooral administration |
| 7 | Active comparator | Drug: ezetimibeoral administration 10mg breakfast timing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with mild to moderate primary hypercholesterolemia with stabilized LDL-C baseline ≥130 mg/dL and ≤ 250 mg/dL (≥ 3.36 mmol/L and ≤ 6.46 mmol/L)
- Male aged ≥ 18 years or postmenopausal women at screening
Key exclusion criteria (9 listed)
- Presence of any clinically significant endocrine disease known to influence serum lipids or lipoproteins
- Patients with type 1 diabetes
- Presence or history of cancer within the past five years
- Triglycerides ≥ 300 mg/dL (3.39 mmol/L)
- Fasting plasma glucose > 160 mg/dL (8.9 mmol/L)
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 | Drug | 1, 2, 3, 4, 5 |
| placebo | Drug | 6 |
| ezetimibe | Drug | 7 |
Primary outcome
Percent change in LDL-C from baseline
Time frame: 4 weeks
2 secondary outcomes
Absolute change from in LDL-C levels
Time frame: 4 weeks
Percent change in other lipids and lipoprotein fractions from baseline
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2008.
- Related InfoLink provided by the sponsor.
Related trials for Hypercholesterolemia
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVE5530 and ezetimibe in people with Hypercholesterolemia, run by Sanofi at 6 sites in 6 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 2 inclusion and 9 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 16 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Chile, Hungary, Mexico, Russia, South Korea and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in LDL-C from baseline (time frame: 4 weeks). 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 Dec 2008.