NCT00263042|TerminatedPhase 3DMC

Study Stopped

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

Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

CRESCENDO

Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors

Sanofi ClinicalTrials.gov

Compare

2 other identifiers

EFC58262005-002942-20

Study Type

interventional

Target

18,695

Locations

41 countries

Sites

Timeline

RegisteredDec 2005

StartedDec 2005

CompletionApr 2009

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

18,695

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2005

Typical duration for phase_3

Geographic Reach

41 countries

41 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

Study Start

First participant enrolled

December 1, 2005

Completed

5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed

Last Updated

May 20, 2016

Status Verified

April 1, 2016

Enrollment Period

3.3 years

First QC Date

December 6, 2005

Last Update Submit

April 21, 2016

Conditions

Cardiovascular Disease

Keywords

Myocardial infarctioncerebrovascular accidentobesity

Outcome Measures

Primary Outcomes (1)

First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death
From randomization up to common study end date (33-50 months)

Secondary Outcomes (2)

First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization
From randomization up to common study end date (33-50 months)
All-cause mortality
From randomization up to common study end date (33-50 months)

Study Arms (2)

Rimonabant

EXPERIMENTAL

Rimonabant 20 mg once daily

Drug: Rimonabant

Placebo

PLACEBO COMPARATOR

Placebo (for Rimonabant) once daily.

Drug: Placebo (for Rimonabant)

Interventions

RimonabantDRUG

Tablet, oral administration

Also known as: SR141716, Acomplia

Rimonabant

Placebo (for Rimonabant)DRUG

Tablet, oral administration

Placebo

Eligibility Criteria

Age55 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.