NCT00228176|TerminatedPhase 3DMC

Study Stopped

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

Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant

AUDITOR

Randomized, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Intima-media Thickness (CIMT), in Overweight Patients With Additional Risk Factors

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC58282005-001612-49

Study Type

interventional

Target

661

Locations

6 countries

Sites

Timeline

RegisteredSep 2005

StartedAug 2005

CompletionApr 2009

Brief Summary

Objectives:

Primary: To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo, on the quantitative progression of atherosclerosis as assessed by carotid artery intima-media thickness (CIMT)
Secondary: To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerosis patients.

Trial Health

Monitor

Trial Health Score

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

Enrollment

661

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Aug 2005

Typical duration for phase_3

Geographic Reach

6 countries

6 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

3.7 years study duration

Study Start

First participant enrolled

August 1, 2005

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed

3.5 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

3.7 years

First QC Date

September 26, 2005

Last Update Submit

April 21, 2016

Conditions

Carotid Artery Plaque Arteriosclerosis Obesity Metabolic Syndrome X

Keywords

Metabolic syndromeCarotid Atherosclerosis

Outcome Measures

Primary Outcomes (1)

Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT)
Month 30

Secondary Outcomes (2)

First occurrence of any component of stroke/myocardial infarction (MI)/cardiovascular death
From randomization to Month 35
First occurrence of any component of stroke/MI/cardiovascular death/hospitalization for revascularization procedure, unstable angina, transient ischemic attack (TIA)
From randomization to Month 35

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:

Written and signed informed consent
Age greater than or equal to 55 years
Abdominal obesity defined by waist circumference \> 88 cm (35 inches) in women and \> 102 cm (40 inches) in men
Metabolic syndrome diagnosed on the basis of at least two of the following additional risk factors:
Triglyceride level equal to or greater than 150 mg/dL
HDL cholesterol less than 40 mg/dL in men or 50 mg/dL in women
Fasting glucose of equal to or greater than 110 mg/dL
High blood pressure defined as equal to or greater than 140 mmHg systolic and/or equal to or greater than 90 mmHg diastolic at screening visit or current treatment by antihypertensive medication.
Ultrasonographic evidence at Screening quantitative B-mode ultrasound imaging of a minimal CIMT measurement of greater than or equal to 0.7 mm in either of the far walls of the common carotid artery, and maximal CIMT measurement less than 3 mm in any carotid artery segment.
All 6 carotid artery segments must have ultrasound images for all CIMT measurements
Screening CIMT recording deemed to be of acceptable CIMT image quality, and demonstrating adherence to the CIMT interrogation protocol, as determined by the Imaging Core Laboratory's assessment.

You may not qualify if:

History of very low calorie diet or surgical procedures for weight loss within 6 months prior to screening visit
Obesity of known endocrine origin
Uncontrolled diabetes, i.e. with HbA1c \> 10%
Anticipated survival less than 27 months
Presence of any severe medical or psychological condition, that in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study
Presence of any other condition (e.g. geographic, social, or other), actual or anticipated, that the Investigator feels would restrict or limit the subject's participation for the duration of the study
Receipt of any investigational treatment (drug or device) within 30 days prior to Screening
Previous participation in a rimonabant study
Total occlusion of any carotid artery segment
Previous history of carotid intervention
Patient considered at high risk of carotid intervention during the next 27 months

Contact the study team to confirm eligibility.