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COMPLETED Phase 2

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

NCT00443287 · View on ClinicalTrials.gov ↗

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

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00443287

The ClinicalTrials.gov registry entry for NCT00443287 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 553 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00443287 reports 7 study locations spanning 2 distinct geographic areas — top geographies include Other, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00443287?

The interventions under investigation include: placebo (DRUG), ataciguat (HMR1766) (DRUG), cilostazol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00443287?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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