NCT Number: NCT00440154
A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Sanofi-Aventis Administrative Office, Santiago, Chile
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo
Drugezetimibe
DrugPrimary outcomes
-
Percent change in LDL-C from baseline
Time frame: 4 weeks
Secondary outcomes
-
Absolute change from in LDL-C levels
Time frame: 4 weeks
-
Percent change in other lipids and lipoprotein fractions from baseline
Time frame: 4 weeks
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Lead sponsor
Sanofi
Industry
Registry information
Official study title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,Ezetimibe-Calibrated, Multicenter Study Evaluating the Safety and Efficacy of Four Doses and Two Dose-Regimens of AVE5530 Over 4 Weeks in Patients With Mild to Moderate Primary Hypercholesterolemia
Important dates
- Study start
- 2007
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Feb 26, 2007
- Registry last updated
- Dec 16, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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