Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes "CRESCENDO"

Terminated

Phase 3 Results N/A

Trial Description

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.

Detailed 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.

Trial Stopped: Company decision taken in light of demands by certain national health authorities

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: once daily
    ARM 1: Kind: Experimental
    Label: 2
  • Rimonabant (SR141716) Drug
    Intervention Desc: 20 mg once daily
    ARM 1: Kind: Experimental
    Label: 1
  • Rimonabant Drug
    Other Names: SR141716; Acomplia
    Intervention Desc: Tablet, oral administration
    ARM 1: Kind: Experimental
    Label: Rimonabant
    Description: Rimonabant 20 mg once daily
  • Placebo (for Rimonabant) Drug
    Intervention Desc: Tablet, oral administration
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo (for Rimonabant) once daily.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary First occurrence of myocardial infarction, stroke, and cardiovascular (CV) death study period No
Secondary First occurrence of myocardial infarction, stroke, CV death, and CV hospitalization study period No
Secondary All-cause mortality study period No
Primary First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death From randomization up to common study end date (33-50 months) No
Secondary First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization From randomization up to common study end date (33-50 months) No

Sponsors