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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00300339
Other study ID # ACT4791
Secondary ID
Status Completed
Phase Phase 2
First received March 7, 2006
Last updated December 18, 2008
Start date February 2006
Est. completion date December 2007

Study information

Verified date December 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaCzech Republic: State Institute for Drug Control
Study type Interventional

Clinical Trial Summary

To investigate in patients suffering from intermittent claudication due to Fontaine stage II PAD whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of SL650472 to placebo, and to calibrate such effect versus cilostazol


Recruitment information / eligibility

Status Completed
Enrollment 599
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- 1. Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis origin (symptoms present for 6 months or longer and not significantly changed within the past 3 months);

- 2. ICD of 30 to 200 m at screening constant workload treadmill test

- 3. Doppler-measured pre-treadmill ABI of 0.90 or lower after 10 minutes of rest or, for patients with an ABI of greater than 1.3 (non-compressible arteries), a Toe-Brachial Index (TBI) of less than 0.7.

Exclusion Criteria:

- 1. Age below 40 years and/or onset of symptoms of PAD before the age of 40 years;

- 2. Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome);

- 3. Limb-threatening (grades III and IV) chronic limb ischemia, manifested by ischemic rest pain, ulceration, or gangrene.

- 4. Patients with a history of malignant or proliferate breast disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
SL650472, Clopidogrel


Locations

Country Name City State
Belgium Sanofi-Aventis Administrative Office Diegem
Canada Sanofi-Aventis Administrative Office Laval
Czech Republic Sanofi-Aventis Administrative Office Praha
Germany Sanofi-Aventis Administrative Office Berlin
Mexico Sanofi-Aventis Administrative Office Mexico
Russian Federation Sanofi-Aventis Administrative Office Moscow
Sweden Sanofi-Aventis Administrative Office Bromma
Ukraine Sanofi-Aventis Administrative Office Kiev
United States Sanofi-Aventis Administrative Office Bridgewater New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Germany,  Mexico,  Russian Federation,  Sweden,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline
Secondary Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline
Secondary Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline,
Secondary Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires,
Secondary Hemodynamic measurement post treadmill test (ABI/TB).
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