MedDataX Logo

Mixed Antagonist of Serotonin for Claudication Optimal Therapy

NCT ID: NCT00300339

Last Updated: 2008-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

599 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intermittent Claudication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SL650472, Clopidogrel

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

sanofi-aventis

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-Aventis Administrative Office

Laval, , Canada

Site Status

Sanofi-Aventis Administrative Office

Prague, , Czechia

Site Status

Sanofi-Aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-Aventis Administrative Office

México, , Mexico

Site Status

Sanofi-Aventis Administrative Office

Moscow, , Russia

Site Status

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Site Status

Sanofi-Aventis Administrative Office

Kiev, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hungary United States Belgium Canada Czechia Germany Mexico Russia Sweden Ukraine

Related Links

Access external resources that provide additional context or updates about the study.

http://www.sanofi-aventis.com

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ACT4791

Identifier Type: -

Identifier Source: org_study_id