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NCT00443287 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease

A Phase 2 study of Intermittent Claudication, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
553
Enrollment target
7
Study locations

NCT00443287 is a Phase 2 study of Intermittent Claudication that has completed, run by Sanofi. The registered enrollment target is 553 participants, above the 166-participant average among 11 other Intermittent Claudication trials with a reported enrollment target (233% higher). The trial reports 7 study locations across 2 states.

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The verdict

NCT00443287, a Phase 2 study of Intermittent Claudication, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
553 participants
Enrollment target
7
Study locations

Study Summary

The primary objective is to investigate in patients suffering from intermittent claudication due to Fontaine stage II Peripheral Arterial Disease (PAD) whether a 26-week treatment by HMR1766 on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of HMR1766 to placebo, and calibrating such effect versus cilostazol.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG ataciguat (HMR1766)
  • DRUG cilostazol

Study Locations (7)

Other

  • Sanofi-Aventis Administrative Office - Vienna
  • Sanofi-Aventis Administrative Office - Laval
  • Sanofi-Aventis Administrative Office - Paris
  • Sanofi-Aventis Administrative Office - Warsaw
  • Sanofi-Aventis Administrative Office - Moscow
  • Sanofi-Aventis Administrative Office - Midrand

New Jersey

  • Sanofi-Aventis Administrative Office - Bridgewater

Trial Details

FieldValue
Enrollment Target 553 participants
Start Date 2007-02
Est. Completion 2008-10
Phase Phase 2

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00443287

The ClinicalTrials.gov registry entry for NCT00443287 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 553 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 166-participant average among 11 other Intermittent Claudication trials with a reported enrollment target (233% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Intermittent Claudication appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.

NCT00443287 reports 7 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.

Frequently Asked Questions

What is clinical trial NCT00443287 about?

NCT00443287 is a clinical study titled "Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease". The primary objective is to investigate in patients suffering from intermittent claudication due to Fontaine stage II Peripheral Arterial Disease (PAD) whether a 26-week treatment by HMR1766 on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of HMR1766 t...

What is the current status of trial NCT00443287?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 553 participants. The study started on 2007-02. Estimated completion is 2008-10.

What conditions does trial NCT00443287 study?

This clinical trial studies the following conditions: Intermittent Claudication.

What interventions are being tested in trial NCT00443287?

The interventions under investigation include: placebo (DRUG), ataciguat (HMR1766) (DRUG), cilostazol (DRUG).

Who is sponsoring clinical trial NCT00443287?

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

Where is trial NCT00443287 being conducted?

This trial has 7 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.