Prevention of Restenosis Following Revascularization

This study has been terminated.

(Study was terminated due to changing sponsor priorities, and was not based on safety or outcomes data.)

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00518284

First received: August 16, 2007

Last updated: February 21, 2012

Last verified: February 2012

History of Changes

Results First Received: February 21, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Vascular Disease, Peripheral
Intervention:	Drug: Nanoparticle Paclitaxel

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
No text entered.

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
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Participant Flow: Overall Study

	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
STARTED	3	1	2
COMPLETED	0	0	0
NOT COMPLETED	3	1	2
Adverse Event	1	0	0
Study Termination	2	1	2

Baseline Characteristics

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Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
Total	Total of all reporting groups

Baseline Measures

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV	Total
Number of Participants [units: participants]	0	3	1	2	6
Age [units: years] Mean ± Standard Deviation		69.7 ± 10.50	84.0 ± NA ^[1]	69.0 ± 12.73	71.8 ± 10.59
Gender [units: participants]
Female		0	0	1	1
Male		3	1	1	5
Race/Ethnicity, Customized [units: participants]
Asian		0	0	1	1
White, Non-Hispanic and Non-Latino		3	1	1	5

[1]	Standard deviation could not be calculated as only one patient was randomized to this treatment group.

Outcome Measures

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1. Primary:

Target Vessel Revascularization at 9 Months [ Time Frame: 9 months ]

Measure Type	Primary
Measure Title	Target Vessel Revascularization at 9 Months
Measure Description	Target vessel revascularization (TVR) was defined as percutaneous revascularization or bypass of the target lesion or any segment of the artery containing the target lesion. The percentage of participants requiring revascularization of the target vessel was determined by stenosis of > 50% confirmed by angiography.
Time Frame	9 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	0	0	0
Target Vessel Revascularization at 9 Months [units: percentage of participants]

No statistical analysis provided for Target Vessel Revascularization at 9 Months

2. Secondary:

Systolic Velocity Ratio (SVR) > 2.0 [ Time Frame: 9 months ]

Measure Type	Secondary
Measure Title	Systolic Velocity Ratio (SVR) > 2.0
Measure Description	The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound.
Time Frame	9 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	0	0	0
Systolic Velocity Ratio (SVR) > 2.0 [units: percentage of participants]

No statistical analysis provided for Systolic Velocity Ratio (SVR) > 2.0

3. Secondary:

Change From Baseline in Walking Impairment Questionnaire (WIQ) Score [ Time Frame: Baseline and Month 9 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Walking Impairment Questionnaire (WIQ) Score
Measure Description	The Walking Impairment Questionnaire (WIQ) is utilized to characterize a patient’s walking ability. Scores range from 0 (no difficulty) to 100 (much difficulty).
Time Frame	Baseline and Month 9
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	0	0	0
Change From Baseline in Walking Impairment Questionnaire (WIQ) Score [units: scores on a scale] Mean ± Standard Deviation

No statistical analysis provided for Change From Baseline in Walking Impairment Questionnaire (WIQ) Score

4. Secondary:

Decrease in Ankle Brachial Index (ABI) > 0.15 [ Time Frame: Baseline and Month 9 ]

Measure Type	Secondary
Measure Title	Decrease in Ankle Brachial Index (ABI) > 0.15
Measure Description	The percentage of participants with a decrease in the Ankle Brachial Index (ABI) > 0.15. Ankle Brachial Index = Systolic Ankle Pressure / Systolic Brachial Pressure.
Time Frame	Baseline and Month 9
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	0	0	0
Decrease in Ankle Brachial Index (ABI) > 0.15 [units: percentage of participants]

No statistical analysis provided for Decrease in Ankle Brachial Index (ABI) > 0.15

5. Secondary:

Target Lesion Revascularization (TLR) at 9 Months [ Time Frame: 9 months ]

Measure Type	Secondary
Measure Title	Target Lesion Revascularization (TLR) at 9 Months
Measure Description	Target lesion revascularization (TLR) was defined as repeat percutaneous intervention or bypass surgery of the previously treated target lesion (or blockage). The percentage of participants requiring revascularization of the target lesion was determined by stenosis of > 50% confirmed by angiography.
Time Frame	9 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	0	0	0
Target Lesion Revascularization (TLR) at 9 Months [units: percentage of participants]

No statistical analysis provided for Target Lesion Revascularization (TLR) at 9 Months

6. Secondary:

Number of Deaths [ Time Frame: Up to 11 months ]

Measure Type	Secondary
Measure Title	Number of Deaths
Measure Description	Number of patients who died due to any cause.
Time Frame	Up to 11 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated population.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	3	1	2
Number of Deaths [units: participants]		1	0	0

No statistical analysis provided for Number of Deaths

7. Secondary:

Number of Participants With Myocardial Infarction (MI) [ Time Frame: Up to 11 months ]

Measure Type	Secondary
Measure Title	Number of Participants With Myocardial Infarction (MI)
Measure Description	The number of patients experiencing Myocardial Infarction (MI) during the study. Myocardial Infarction was defined as new pathologic Q waves of at least 0.04 seconds, or an increase in serum creatine kinase to more than twice the normal code together with a pathologic increase in myocardial isoenzymes.
Time Frame	Up to 11 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated population.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	3	1	2
Number of Participants With Myocardial Infarction (MI) [units: participants]		0	0	0

No statistical analysis provided for Number of Participants With Myocardial Infarction (MI)

8. Secondary:

Number of Participants With a Stroke [ Time Frame: Up to 11 months ]

Measure Type	Secondary
Measure Title	Number of Participants With a Stroke
Measure Description	The number of patients experiencing a stroke during the study. Stroke was defined as any sudden development of neurological deficits lasting more than 24 hours, and if a brain imaging study is performed it shows an infarction or hemorrhage. A transient ischemic attack is a neurological deficit lasting less than 24 hours and, if an imaging study is performed, shows no evidence of infarction or hemorrhage.
Time Frame	Up to 11 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated population.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	3	1	2
Number of Participants With a Stroke [units: participants]		0	0	0

No statistical analysis provided for Number of Participants With a Stroke

9. Secondary:

Minimum Lumen Diameter [ Time Frame: 9 months ]

Measure Type	Secondary
Measure Title	Minimum Lumen Diameter
Measure Description	Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically.
Time Frame	9 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	0	0	0
Minimum Lumen Diameter [units: mm] Mean ± Standard Deviation

No statistical analysis provided for Minimum Lumen Diameter

10. Secondary:

Late Loss [ Time Frame: Day 1 (following revascularization) and 9 months ]

Measure Type	Secondary
Measure Title	Late Loss
Measure Description	Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm.
Time Frame	Day 1 (following revascularization) and 9 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	0	0	0
Late Loss [units: mm] Mean ± Standard Deviation

No statistical analysis provided for Late Loss

11. Secondary:

Percentage of Participants With Binary Restenosis [ Time Frame: 9 months ]

Measure Type	Secondary
Measure Title	Percentage of Participants With Binary Restenosis
Measure Description	Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography.
Time Frame	9 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	0	0	0
Percentage of Participants With Binary Restenosis [units: percentage of participants]

No statistical analysis provided for Percentage of Participants With Binary Restenosis

12. Secondary:

Diameter Stenosis [ Time Frame: 9 months ]

Measure Type	Secondary
Measure Title	Diameter Stenosis
Measure Description	Diameter stenosis is calculated as [1 - (minimum lumen diameter (MLD) / reference vessel diameter)] * 100, where the reference vessel diameter is the vessel diameter measured in a healthy segment of the target vessel proximal as close as possible to the lesion.
Time Frame	9 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Reporting Groups

	Description
Control	Following revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IV	Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
During Flow Arrest	Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
During Flow Arrest + IV	Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.

Measured Values

	Control	Proximal to Lesion + IV	During Flow Arrest	During Flow Arrest + IV
Number of Participants Analyzed [units: participants]	0	0	0	0
Diameter Stenosis [units: percent diameter stenosis] Mean ± Standard Deviation

No statistical analysis provided for Diameter Stenosis

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: Study data will not be published in part before complete multicenter data have been reported in full, unless more than 18 months have elapsed since completion of the Study. Investigator/institution must supply copy of presentation or publication to Celgene 30 days of prior to submission for publication. Celgene may request in writing within that 30 days that Celgene Confidential Information be deleted or be granted a 60 day delay prior to publication for intellectual property filings.

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: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00518284 History of Changes
Other Study ID Numbers:	CVR002
Study First Received:	August 16, 2007
Results First Received:	February 21, 2012
Last Updated:	February 21, 2012
Health Authority:	United States: Food and Drug Administration

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