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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00766688




Registration number
NCT00766688
Ethics application status
Date submitted
3/10/2008
Date registered
6/10/2008
Date last updated
16/05/2016

Titles & IDs
Public title
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia
Scientific 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
Secondary ID [1] 0 0
EudraCT 2008-002849-23
Secondary ID [2] 0 0
EFC10841
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AVE5530
Treatment: Drugs - Placebo

Experimental: 25 mg/day AVE5530 -

Experimental: 50 mg/day AVE5530 -

Placebo comparator: Placebo -


Treatment: Drugs: AVE5530
* one tablet in the evening with dinner
* in addition to high doses of statin treatment

Treatment: Drugs: Placebo
* one tablet in the evening with dinner
* in addition to high doses of statin treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent change from baseline in calculated LDL-C
Timepoint [1] 0 0
At week 12
Secondary outcome [1] 0 0
Percent change from baseline in calculated LDL-C
Timepoint [1] 0 0
At 6 months and 12 months
Secondary outcome [2] 0 0
Percent change from baseline in Total-Cholesterol and Apo-B
Timepoint [2] 0 0
At 12 weeks, 6 months and 12 months

Eligibility
Key inclusion criteria
* Adults with severe primary hypercholesterolemia and cholesterol levels not controlled on ongoing stable statin treatment at maximum doses.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
643
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Belgium
State/province [2] 0 0
Diegem
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Sofia
Country [4] 0 0
Canada
State/province [4] 0 0
Laval
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Praha
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Israel
State/province [7] 0 0
Natanya
Country [8] 0 0
Netherlands
State/province [8] 0 0
Gouda
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Moscow
Country [10] 0 0
Slovakia
State/province [10] 0 0
Brastislava
Country [11] 0 0
South Africa
State/province [11] 0 0
Midrand
Country [12] 0 0
Ukraine
State/province [12] 0 0
Kiev

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 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.
Trial website
https://clinicaltrials.gov/study/NCT00766688
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00766688