Long Term Open Follow-up With H376/95 vs. Warfarin | NCT00206063

Studies
Long Term Open Follow-up With H376/95 vs. Warfarin

NCT00206063

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Nov 15, 2010Estimated

Enrollment

220

Phase

Phase 2

Conditions

Stroke Prevention in Patients With Atrial Fibrillation

Interventions

EXANTA

Countries

United States
Belgium
Czechia
Denmark
Finland
Norway
Poland
Sweden
United Kingdom

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
D4004C00004

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.

Expanded Access Info

Start Date

Aug 1999

Primary Completion Date

Jun 2004Actual

Completion Date

Apr 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

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

Nov 10, 2010

Last Update Posted Date

Nov 15, 2010Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.

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

220

Name	Type	Description	Arm Group Labels	Other Names
EXANTA	Drug			Ximelagatran

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent.
Completion of the study SH-TPA-0002, history of chronic atrial fibrillation (i.e. rapidly beating heart), at least one risk factor for stroke (e.g. high blood pressure, age over 65, previous stroke or similar attack, diabetes or coronary heart disease)

Exclusion Criteria:

Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Palo Alto	California		United States
Research Site

Intervention Browse Module

MeSH Terms

ID	Term
C426686	ximelagatran

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided