Clinical trial NCT00718965: Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary Hypercholesterolemia
Official title: A Double-blind, Randomized, 12-month, Placebo-controlled, Parallel Group, Fixed-dose Study to Evaluate the Efficacy and Safety of AVE5530 25mg/Day and AVE5530 50 mg/Day in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: Primary hypercholesterolemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 826
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is aiming at assessing the efficacy and safety of AVE5530 (25mg and 50mg) in a double-blind comparison with placebo in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of AVE5530 on LDL-C level reduction as adjunct to a controlled diet. The effects of AVE5530 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 and a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.

Eligibility criteria: Inclusion Criteria:

* Adults with high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy

Exclusion Criteria:

* 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
  * 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.

Primary outcomes:
measure: percent change from baseline in calculated LDL-C
timeFrame: at week 12
Secondary outcomes:
measure: percent change from baseline in calculated LDL-C
timeFrame: at 6 months and 12 months
measure: percent change from baseline in total cholesterol and Apo-B
timeFrame: at 12 weeks, 6 months and 12 months
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Puerto Rico
country: Puerto Rico
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Wake Forest University Health Sciences, North Carolina, US
name: John CROUSE, MD
role: PRINCIPAL_INVESTIGATOR
References: