Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00766688
• Date of registration: 03/10/2008
• Prospective Registration: No
• Primary sponsor: Sanofi
• 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
• Date of first enrolment: October 2008
• Target sample size: 643
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00766688
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Bulgaria, Canada, Czech Republic, France, Israel, Netherlands, Russian Federation, Slovakia, South Africa, Ukraine, United States

Contacts

• Name: ICD CSD
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults with severe primary hypercholesterolemia and cholesterol levels not
controlled on ongoing stable statin treatment at maximum doses.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypercholesterolemia

Intervention(s)

Drug: AVE5530

Drug: Placebo

Primary Outcome(s)

Percent change from baseline in calculated LDL-C [Time Frame: At week 12]

Secondary Outcome(s)

Percent change from baseline in Total-Cholesterol and Apo-B [Time Frame: At 12 weeks, 6 months and 12 months]

Percent change from baseline in calculated LDL-C [Time Frame: At 6 months and 12 months]

Secondary ID(s)

EudraCT 2008-002849-23

EFC10841

Source(s) of Monetary Support

Please refer to primary and secondary sponsors