Efficacy and Safety of HMR1766 in Patients With Fontaine... | NCT00443287

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

NCT00443287

Sponsor

Sanofi

Status

Completed

Last Update Posted

May 17, 2018Actual

Enrollment

553Actual

Phase

Phase 2

Conditions

Intermittent Claudication

Interventions

ataciguat (HMR1766)
placebo
cilostazol

Countries

United States
Austria
Canada
France
Poland
Russia
South Africa

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

ID	Type	Description	Link
EudraCT : 2006-004275-35

Status Module

Record Verification Date

May 2018

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 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Mar 2, 2007

First Submission Date that Met QC Criteria

Mar 2, 2007

First Posted Date

Mar 5, 2007Estimated

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

May 3, 2018

Certification/Extension First Submitted that Passed QC Review

May 3, 2018

Certification/Extension First Posted Date

May 8, 2018Actual

Last Update Submitted Date

May 15, 2018

Last Update Posted Date

May 17, 2018Actual

Description Module

Brief Summary

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.

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

553Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Drug: placebo
2	Experimental	dose level 1	Drug: ataciguat (HMR1766)
3	Experimental	dose level 2	Drug: ataciguat (HMR1766)
4	Experimental	dose level 3	Drug: ataciguat (HMR1766)
5	Active Comparator		Drug: cilostazol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ataciguat (HMR1766)	Drug	oral administration	2 3 4

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Secondary efficacy endpoint: percent change in the absolute claudication distance		26 weeks
Safety endpoints: adverse events		study period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis etiology (symptoms present for 6 months or longer and not significantly changed within the past 3 months)
Initial claudication distance of 30 to 250 meters at screening constant workload treadmill test
Confirmation of underlying Peripheral Arterial Disease (PAD) at screening
Confirmation of symptom stability at randomization based on constant workload treadmill test performance
The patient must have optimal cardiovascular risk prevention and appropriate management of PAD, including clopidogrel at the dose of 75mg per day, during the study period

Exclusion Criteria:

Patient participated in investigational clinical trials in the last month prior to screening
Pregnant or breast-feeding woman or woman without documented double birth control measures for at least 3 months prior to randomization
Symptoms of PAD before the age of 40 years
Recent initiations or discontinuation of treatment by vasoactive agents (e.g., pentoxifylline, berprost sodium, papverine, isoxsuprine, nylidrin, cyclandelate, and niacin derivatives). Patients treated by cilostazol within 3 months prior to screening will also be excluded
Recent lower-extremity surgical or endovascular arterial reconstructions or sympathectomy, or recent deep venous thrombosis
Recent occurrence of at least one of the following: acute myocardial infarction, unstable angina, coronary artery bypass graft, percutaenous coronary intervention, transient ischemic attack or stroke

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

ID	Term
C515616	5-chloro-2-(5-chlorothiophene-2-sulfonylamino)-N-(4-(morpholine-4-sulfonyl)phenyl)benzamide
D000077407	Cilostazol

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
D007383	Intermittent Claudication
D004194	Disease