Trial record 1 of 1 for:
NCT00345410
Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00345410
First received: June 27, 2006
Last updated: December 18, 2008
Last verified: December 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Dyslipidemia |
Drug: AVE1625 B |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Absolute change from baseline in body weight at 24 weeks
Secondary Outcome Measures:
- - 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
| Enrollment: | 345 |
| Study Start Date: | June 2006 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345410
Locations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
Sponsors and Collaborators
Sanofi
Investigators
| Principal Investigator: | Julio ROSENSTOCK, MD | Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00345410 History of Changes |
| Other Study ID Numbers: | DRI6412 |
| Study First Received: | June 27, 2006 |
| Last Updated: | December 18, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
obesity and dyslipidemia |
Additional relevant MeSH terms:
|
Obesity Dyslipidemias Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013