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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00766688
• Other study ID #: EFC10841
• Secondary ID: EudraCT 2008-002
• Status: Terminated
• Phase: Phase 3
• First received: October 3, 2008
• Last updated: November 10, 2009
• Start date: October 2008
• Est. completion date: June 2009

Study information

• Verified date: November 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 643
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• AVE5530
one tablet in the evening with dinner in addition to high doses of statin treatment
• Placebo
one tablet in the evening with dinner in addition to high doses of statin treatment

Locations

Country	Name	City	State
Australia	sanofi-aventis Australia & New Zealand administrative office	Macquarie Park	New South Wales
Belgium	Sanofi-Aventis Administrative Office	Diegem
Bulgaria	Sanofi-Aventis Administrative Office	Sofia
Canada	Sanofi-Aventis Administrative Office	Laval
Czech Republic	Sanofi-Aventis Administrative Office	Praha
France	Sanofi-Aventis Administrative Office	Paris
Israel	Sanofi-Aventis Administrative Office	Natanya
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Slovakia	Sanofi-Aventis Administrative Office	Brastislava
South Africa	Sanofi-Aventis Administrative Office	Midrand
Ukraine	Sanofi-Aventis Administrative Office	Kiev
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in calculated LDL-C		At week 12	No
Secondary	Percent change from baseline in calculated LDL-C		At 6 months and 12 months	No
Secondary	Percent change from baseline in Total-Cholesterol and Apo-B		At 12 weeks, 6 months and 12 months	No