Mixed Antagonist of Serotonin for Claudication Optimal Therapy - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00300339

Purpose

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

Condition	Intervention	Phase
Intermittent Claudication	Drug: SL650472, Clopidogrel	Phase II

Drug Information available for: Serotonin Clopidogrel Clopidogrel Bisulfate Cilostazol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Double-Dummy, Randomized, Parallel Group Trial of SL650472 (Three Dose Regimens Versus Placebo and Cilostazol), for 24-Week Improvement of Walking Distance in Patients With Stage II Peripheral Arterial Disease Who Benefit From Optimal Prevention Strategy Including Clopidogrel

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline

Secondary Outcome Measures:

Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline
Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline,
Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires,
Hemodynamic measurement post treadmill test (ABI/TB).

Enrollment:	599
Study Start Date:	February 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300339

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Ukraine
Sanofi-Aventis Administrative Office
Kiev, Ukraine

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	ACT4791
Study First Received:	March 7, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00300339
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Czech Republic: State Institute for Drug Control

Study placed in the following topic categories:

Arterial Occlusive Diseases
Cilostazol
Signs and Symptoms
Peripheral Vascular Diseases
Clopidogrel

Vascular Diseases
Intermittent Claudication
Arteriosclerosis
Serotonin

Additional relevant MeSH terms:

Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009