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Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00345410
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : December 19, 2008
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE June 27, 2006
First Posted Date  ICMJE June 28, 2006
Last Update Posted Date December 19, 2008
Study Start Date  ICMJE June 2006
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2006)
Absolute change from baseline in body weight at 24 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2006)
  • - relative change from baseline to 24 weeks in plasma HDL-cholesterol and triglycerides levels ; - change from baseline to 24 weeks in waist circumference ; Other criteria: glycemic control parameters.
  • Safety: physical examination, vital signs, adverse events, ECG, laboratory tests.
  • Pharmacokinetics: plasma AVE1625 concentrations
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
Official Title  ICMJE A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Three Doses of AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
Brief Summary Primary objective: to assess the effect of AVE1625 on weight loss over a period of 24 weeks in abdominally obese patients with atherogenic dyslipidemia. Secondary objectives: - To assess the dose effect relationship of AVE1625 on HDL-cholesterol and triglycerides plasma levels over a period of 24 weeks - To assess the efficacy of AVE1625 on secondary parameters such as waist circumference and other metabolic parameters over a period of 24 weeks - To assess the safety and tolerabillity of AVE1625 over a period of 24 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Dyslipidemia
Intervention  ICMJE Drug: AVE1625 B
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2008)
345
Original Enrollment  ICMJE
 (submitted: June 27, 2006)
300
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Abdominal obese patients with ·
  • Waist circumference > 102 cm in men and >88 cm in women
  • Dyslipidemia consisting of :

    • Triglycerides ≥ 1.50 g/L (i.e 1.69 mmol/L) and ≤ 7.0 g/L(i.e. 7.90 mmol/L)AND/OR
    • HDL-cholesterol < 50 mg/dL (i.e. 1.29 mmol/L) in women and < 40 mg/dL (i.e. 1.04 mmol/L) in men

Exclusion Criteria:

  • Pregnancy or lactation
  • Women of child-bearing potential with no medically approved contraception
  • Patients with type 1 diabetes
  • Patients with type 2 diabetes must be on a stable dose of oral antidiabetic drugs (excluding glitazones, exenatide, sulfonylurea and nateglinide) and should not receive insulin therapy
  • Patients with any clinically significant endocrine disease
  • Patients on anticoagulants (heparin, warfarin) or with bleeding disorders
  • Clinically relevant disease interfering with subject's safety or making implementation of the study protocol or interpretation of study results difficult
  • Patients with mental retardation or any clinically significant psychiatric disorder
  • History or concurrent substance abuse (other than nicotine or caffeine especially marijuana or hashish)
  • Chronic systemic corticotherapy
  • Patients with weight change > 5kg within 3 months prior to screening
  • Patients should not have received anti-obesity drugs or other drugs for weight reduction in the 3 months prior to screening.
  • The investigator will evaluate whether there are other reasons why a patient may not participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00345410
Other Study ID Numbers  ICMJE DRI6412
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ICD Study Director, sanofi-aventis
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Sanofi
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julio ROSENSTOCK, MD Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA
PRS Account Sanofi
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP