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

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT00443287
Phase
PHASE2
Status
Completed

Conditions

  • Intermittent Claudication

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ataciguat (HMR1766) — DRUG
    oral administration
  • placebo — DRUG
    oral administration
  • cilostazol — DRUG
    oral administration

Study Details

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.

Key Dates

Start date
Feb 28, 2007
Status verified
May 2018
Primary completion
Oct 31, 2008
Completion
Oct 31, 2008

Study Design

Enrollment
553 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 1
  • Experimental: 2
    dose level 1
  • Experimental: 3
    dose level 2
  • Experimental: 4
    dose level 3
  • Active Comparator: 5

Primary Outcome Measure

Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline [ Time Frame: 26 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey08807-

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Sanofi-Aventis Administrative Office· Bridgewater, NJ

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