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NCT00124332 · ClinicalTrials.gov registry record · Phase 3

STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)

A Phase 3 study of Coronary Atherosclerosis, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
839
Enrollment target
9
Study locations

NCT00124332: Completed Phase 3 study of Coronary Atherosclerosis, sponsored by Sanofi.

NCT00124332 is a Phase 3 study of Coronary Atherosclerosis that has completed, run by Sanofi. The registered enrollment target is 839 participants, above the 191-participant average among 5 other Coronary Atherosclerosis trials with a reported enrollment target (339% higher). The trial reports 9 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00124332, a Phase 3 study of Coronary Atherosclerosis, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
839 participants
Enrollment target
9
Study locations

Study Summary

The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Rimonabant (SR141716)

Study Locations (9)

Other

  • sanofi-aventis, Australia - Macquarie Park
  • sanofi-aventis, Belgium - Diegem
  • Sanofi-Aventis Administrative Office - Laval
  • sanofi-aventis, France - Paris
  • sanofi-aventis Italy - Milan
  • sanofi-aventis, Netherlands - Gouda
  • sanofi-aventis Poland - Warsaw
  • sanofi-aventis Spain - Barcelona

Ohio

  • The Cleveland Clinic Foundation - Cleveland

Trial Details

FieldValue
Enrollment Target 839 participants
Start Date 2005-01
Est. Completion 2007-10
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00124332 record still lists

NCT00124332 is an interventional study that assigns participants to a tested intervention. The registered 839 participants enrollment target is mid-sized for trials with a published cap, above the 191-participant average among 5 other Coronary Atherosclerosis trials with a reported enrollment target (339% higher).

The record links to 1 condition, with Coronary Atherosclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00124332 lists 9 locations in 2 states (Other, Ohio).

Frequently Asked Questions

What is clinical trial NCT00124332 about?

NCT00124332 is a clinical study titled "STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)". The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as neede...

What is the current status of trial NCT00124332?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 839 participants. The study started on 2005-01. Estimated completion is 2007-10.

What conditions does trial NCT00124332 study?

This clinical trial studies the following conditions: Coronary Atherosclerosis.

What interventions are being tested in trial NCT00124332?

The interventions under investigation include: Placebo (DRUG), Rimonabant (SR141716) (DRUG).

Who is sponsoring clinical trial NCT00124332?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00124332 being conducted?

This trial has 9 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00124332, the US trial registry maintained by the National Library of Medicine. NCT00124332 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.