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History of Changes for Study: NCT00345410
Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
Latest version (submitted December 18, 2008) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 27, 2006 None (earliest Version on record)
2 December 11, 2006 Study Status
3 December 22, 2006 Recruitment Status, Contacts/Locations and Study Status
4 September 14, 2007 Recruitment Status and Study Status
5 December 18, 2008 Study Status, Study Design, Contacts/Locations, Sponsor/Collaborators and Study Identification
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Study NCT00345410
Submitted Date:  June 27, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: DRI6412
Brief Title: Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
Official Title: 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
Secondary IDs: AVE1625 B
Open or close this module Study Status
Record Verification: June 2006
Overall Status: Recruiting
Study Start: June 2006
Primary Completion:
Study Completion:
First Submitted: June 27, 2006
First Submitted that
Met QC Criteria:
June 27, 2006
First Posted: June 28, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 27, 2006
Last Update Posted: June 28, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Obesity
Dyslipidemia
Keywords: obesity and dyslipidemia
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 300
Open or close this module Arms and Interventions
Intervention Details:
Drug: AVE1625 B
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Absolute change from baseline in body weight at 24 weeks
Secondary Outcome Measures:
1. - 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.
2. Safety: physical examination, vital signs, adverse events, ECG, laboratory tests.
3. Pharmacokinetics: plasma AVE1625 concentrations
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Public Registry ICD
Email: GV-Contact-us@sanofi-aventis.com
Study Officials: Julio ROSENSTOCK, MD
Principal Investigator
Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA
Locations: United States, New Jersey
Sanofi-Aventis
[Recruiting]
Bridgewater, New Jersey, United States, 08807
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Related Info
Available IPD/Information:

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