- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00345410
Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
December 18, 2008 updated by: Sanofi
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
345
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Absolute change from baseline in body weight at 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
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- 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julio ROSENSTOCK, MD, Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
June 27, 2006
First Submitted That Met QC Criteria
June 27, 2006
First Posted (Estimate)
June 28, 2006
Study Record Updates
Last Update Posted (Estimate)
December 19, 2008
Last Update Submitted That Met QC Criteria
December 18, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DRI6412
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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