Hypercholesterolemia
Conditions
Brief 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.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in LDL-C from baseline | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from in LDL-C levels | 4 weeks |
| Percent change in other lipids and lipoprotein fractions from baseline | 4 weeks |
Countries
Chile, Hungary, Mexico, Russia, South Korea, Turkey (Türkiye)
Outcome results
None listed