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

NCT00443287 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 553

Last updated 2018-05-17

No results posted yet for this 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

  • Intermittent Claudication

Interventions

DRUG

ataciguat (HMR1766)

oral administration

DRUG

placebo

oral administration

DRUG

cilostazol

oral administration

Sponsors & Collaborators

Principal Investigators

  • ICD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Austria
  • Canada
  • France
  • Poland
  • Russia
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00443287 on ClinicalTrials.gov