Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes (CRESCENDO)

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Cardiovascular Disease

Treatments: Drug: Rimonabant; Drug: Placebo (for Rimonabant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00263042

EFC5826

2005-002942-20 (EudraCT Number)

Details and patient eligibility

About

The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.

The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.

Full description

The estimated study duration per patient is 36 to 53 months. All patients will be followed from randomization until a common study end date, which will occur when the last patient has been followed for 33 months.

Enrollment: 18,695 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Waist circumference >102 cm (40 inches) males, >88 cm (35 inches) females, with one coronary heart disease (CHD) equivalent or two major risk factors for cardiovascular disease.

• CHD equivalents:

  • Recent (within 3 years)documented heart attack
  • Documented symptomatic coronary artery disease
  • Recent (within 3 years) ischemic cerebrovascular episode (stroke or TIA)
  • Documented symptomatic peripheral arterial disease

• Major risk factors:

  • Documented type 2 diabetes mellitus
  • Metabolic syndrome (NCEP criteria)
  • Asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair
  • Elevated high-sensitivity C-reactive protein
  • Age > or = 65 years for males, age > or = 70 years for females

Exclusion criteria

• Obesity of known endocrine origin
• Pregnant or breastfeeding women
• Very low calorie diet or weight loss surgery within past 6 months
• Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation, including uncontrolled serious psychiatric illness
• Likely cardiovascular intervention within next 1 month
• Allergy to rimonabant or excipients, or prior participation in a rimonabant trial
• Receipt of investigational product within past 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18,695 participants in 2 patient groups, including a placebo group

Rimonabant

Experimental group

Description:

Rimonabant 20 mg once daily

Treatment:

Drug: Rimonabant

Placebo

Placebo Comparator group

Description:

Placebo (for Rimonabant) once daily.

Treatment:

Drug: Placebo (for Rimonabant)