Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00680186

First received: May 16, 2008

Last updated: September 12, 2012

Last verified: September 2012

History of Changes

Results First Received: May 4, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Thromboembolism
Interventions:	Drug: Warfarin Drug: Dabigatran etexilate

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were 2589 patients enrolled/randomised but only 2568 were treated.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Dabigatran 150 mg	bid (twice daily) oral
Warfarin	PRN (as needed) to maintain an INR (international normalised ratio) of 2.0-3.0

Participant Flow: Overall Study

	Dabigatran 150 mg	Warfarin
STARTED	1280 ^[1]	1288 ^[1]
COMPLETED	1155 ^[2]	1172 ^[2]
NOT COMPLETED	125	116
Adverse Event	47	44
Protocol Violation	31	26
Lost to Follow-up	11	6
Withdrawal by Subject	32	39
Unknown	4	1

[1]	Started treatment.
[2]	Completed planned observation time.

Baseline Characteristics

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Reporting Groups

	Description
Dabigatran 150 mg	bid oral
Warfarin	PRN to maintain an INR of 2.0-3.0
Total	Total of all reporting groups

Baseline Measures

	Dabigatran 150 mg	Warfarin	Total
Number of Participants [units: participants]	1280	1288	2568
Age [units: Years] Mean ± Standard Deviation	54.7 ± 16.19	55.1 ± 16.26	54.9 ± 16.22
Gender [units: participants]
Female	499	512	1011
Male	781	776	1557
Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE) [units: participants]
Symptomatic PE and symptomatic DVT	104	117	221
Symptomatic PE	298	297	595
Symptomatic DVT	877	873	1750
No PE and no DVT	1	1	2

Outcome Measures

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1. Primary:

Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE [ Time Frame: For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180) ]

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2. Secondary:

Number of Participants With Recurrent Symptomatic VTE and All Deaths [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

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3. Secondary:

Number of Participants With Recurrent Symptomatic DVT [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

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4. Secondary:

Number of Participants With Recurrent Symptomatic Non-fatal PE [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

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5. Secondary:

Number of Participants Who Died Due to VTE [ Time Frame: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224) ]

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6. Secondary:

Number of Participants Who Died (Any Cause) [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

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7. Secondary:

Number of Participants With Major Bleeding Events (MBE) [ Time Frame: From first intake of study drug to last intake of study drug + 6 days ]

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8. Other Pre-specified:

Number of Participants With Acute Coronary Syndrome (ACS) [ Time Frame: From first intake of study drug to last contact date ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00680186 History of Changes
Other Study ID Numbers:	1160.46, 2007-002631-86
Study First Received:	May 16, 2008
Results First Received:	May 4, 2012
Last Updated:	September 12, 2012
Health Authority:	Australia: Dept of Health and Ageing Therapeutic Goods Admin Brazil: National Health Surveillance Agency Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia Canada: Health Canada, Therapeutic Products Directorate China: Food and Drug Administration Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10 Denmark: Danish Medicines Agency France: AFSSAPS Great Britain: MHRA Hungary: National Institute of Pharmacy, H-1051 Budapest India: Drugs Controller General of India Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ethics Committee Korea, Republic of: Korea Drug and Food Administration Malaysia: National Pharmaceutical Control Bureau Netherlands: Central Committee Research Involving Human Subjects New Zealand: Multicentre Ethics Committee/Medsafe Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Philippines: Department of Health Poland: Registration Medicinal Product Medical Device Biocidal Product Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Singapore: Health Sciences Authority,Ministry of Health Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 South Africa: MCC (Medicines Control Council) Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency Taiwan: Department of Health Thailand: Ministry of Public Health Turkey: Ministry of Health Central Ethics Committee Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) United States: Food and Drug Administration

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