Trial to assess the effects of rimonabant 20 mg in patients with abdominal obesity and microalbuminuria, with type 2 diabetes mellitus or dyslipidaemia with or without other cardiometabolic risk factors.

Phase 1

• Conditions: Patients with abdominal obesity, with type 2 diabetes mellitus or dyslipidaemia, with or without other cardiometabolic riskfactors.; MedDRA version: 17.1Level: LLTClassification code 10059179Term: Abdominal obesitySystem Organ Class: 100000004861; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2006-002951-33-ES
• Lead Sponsor: sanofi-aventis, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-01-29
• Study Start: 2015-01-27
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

1. Men or women aged ? 30 years and < 75 years.
2. BMI > 27 kg/m2 and < 40 kg/m2.
3. Willingness and ability to comply with the study protocol.
4. Written informed consent at the time of enrolment into the study.
5. Waist circumference > 102 cm in men and > 88 cm in women.
6. Microalbuminuria ? 20 mg/g creatinine and < 300 mg/g creatinine in at least
two of three morning urine samples taken on 3 separate days prior to the
baseline visit.
7. Type 2 diabetes and/or dyslipidaemia.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Breastfeeding or pregnant women or who expect to become pregnant.
2. Non-use of approved methods of contraception in women of child-bearing
potential.
3. History of very low calorie diet in the 3 months prior to the screening visit
(<1200 kcal/day).
4. Change in weight > 5 kg in the 3 months prior to the screening visit.
5. History of surgery for weight loss (such as vertical banded gastroplasty,
gastric by-pass, etc.)
6. History of bulimia or anorexia nervosa according to DSM-IV definition.
7. Any clinically significant endocrine disorder, in the opinion of the
investigator, especially known alterations in the blood concentration of TSH
and free T4.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified