Mixed Antagonist of Serotonin for Claudication Optimal Th... | NCT00300339

Studies
Mixed Antagonist of Serotonin for Claudication Optimal Therapy

NCT00300339

Sponsor

Sanofi

Status

Completed

Last Update Posted

Dec 19, 2008Estimated

Enrollment

599Actual

Phase

Phase 2

Conditions

Intermittent Claudication

Interventions

SL650472, Clopidogrel

Countries

United States
Belgium
Canada
Czechia
Germany
Mexico
Russia
Sweden
Ukraine

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Mar 7, 2006

First Submission Date that Met QC Criteria

Mar 7, 2006

First Posted Date

Mar 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2008

Last Update Posted Date

Dec 19, 2008Estimated

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

599Actual

Name	Type	Description	Arm Group Labels	Other Names
SL650472, Clopidogrel	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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,

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis Administrative Office

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D007383	Intermittent Claudication

Ancestor Terms

ID	Term
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077144	Clopidogrel

Ancestor Terms

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided