Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease (SWAP-2)

• ClinicalTrials.gov Identifier: NCT01587651
• Recruitment Status: Completed
• First Posted: April 30, 2012
• Results First Posted: April 29, 2014
• Last Update Posted: January 9, 2019
• Sponsor: Daiichi Sankyo, Inc.
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): Daiichi Sankyo, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Coronary Artery Disease
• Interventions: Drug: Prasugrel Loading Dose; Drug: Prasugrel Maintenance Dose; Drug: Ticagrelor Maintenance Dose
• Enrollment: 110

Participant Flow

Recruitment Details	All subjects must have been taking low dose aspirin (ASA) (75 mg to 150 mg once daily-QD) for at least 7 days prior to Screening (Visit 1), and must have continued the same regimen throughout the study.
Pre-assignment Details	The study consisted of a 3 to 5 day ticagrelor run-in phase followed by randomized treatment on 1 of 2 prasugrel regimens or continued ticagrelor

Arm/Group Title	Prasugrel Loading Dose	Prasugrel Maintenance Dose	Ticagrelor Maintenance Dose
Arm/Group Description	Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD) Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets	Prasugrel 10 mg QD MD Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet	Ticagrelor 90 mg twice-daily (BID) MD Ticagrelor Maintenance Dose : one 90mg film coated tablet
Period Title: Overall Study
Started	34	41	35
Completed	34	38	34
Not Completed	0	3	1
Reason Not Completed
Adverse Event	0	1	0
Protocol Violation	0	1	1
Withdrawal by Subject	0	1	0

Baseline Characteristics

Arm/Group Title		Prasugrel Loading Dose	Prasugrel Maintenance Dose	Ticagrelor Maintenance Dose	Total
Arm/Group Description		Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD) Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets	Prasugrel 10 mg QD MD Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet	Ticagrelor 90 mg twice-daily (BID) MD Ticagrelor Maintenance Dose : one 90mg film coated tablet	Total of all reporting groups
Overall Number of Baseline Participants		34	41	35	110
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	24 70.6%	28 68.3%	22 62.9%	74 67.3%
	>=65 years	10 29.4%	13 31.7%	13 37.1%	36 32.7%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
		57.8 (9.69)	58.5 (8.84)	61.5 (6.87)	59.2 (8.62)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
	Female	10 29.4%	11 26.8%	8 22.9%	29 26.4%
	Male	24 70.6%	30 73.2%	27 77.1%	81 73.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
	Hispanic or Latino	1 2.9%	3 7.3%	4 11.4%	8 7.3%
	Not Hispanic or Latino	33 97.1%	36 87.8%	30 85.7%	99 90.0%
	Unknown or Not Reported	0 0.0%	2 4.9%	1 2.9%	3 2.7%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
	American Indian or Alaska Native	1 2.9%	0 0.0%	0 0.0%	1 0.9%
	Asian	0 0.0%	1 2.4%	0 0.0%	1 0.9%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	7 20.6%	7 17.1%	4 11.4%	18 16.4%
	White	26 76.5%	33 80.5%	30 85.7%	89 80.9%
	More than one race	0 0.0%	0 0.0%	1 2.9%	1 0.9%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	34 participants	41 participants	35 participants	110 participants
United States		30	36	32	98
United Kingdom		4	5	3	12
weight; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
		97.0 (17.70)	95.4 (18.85)	89.4 (19.35)	94.0 (18.77)
height; Mean (Standard Deviation); Unit of measure: Cm
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
		171.2 (8.74)	171.9 (10.15)	174.3 (9.14)	172.4 (9.41)
body mass index; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
		33.2 (5.88)	32.3 (5.92)	29.2 (4.82)	31.6 (5.77)
diabetes mellitus history [1]; Measure Type: Number; Unit of measure: Participants
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
		14	12	5	31
		[1] Measure Description: number of participants with diabetes mellitus sum of categories does not equal number of participants due to not all participants having this specific medical condition
hypertension history [1]; Measure Type: Number; Unit of measure: Participants
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
		26	29	24	79
		[1] Measure Description: number of participants with hypertension susum of categories does not equal number of participants due to not all participants having this specific medical condition
hyperlipidemia history [1]; Measure Type: Number; Unit of measure: Participants
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
		32	35	31	98
		[1] Measure Description: number of participants with hyperlipidemia sum of categories does not equal number of participants due to not all participants having this specific medical condition
peripheral artery disease history [1]; Measure Type: Number; Unit of measure: Participants
	Number Analyzed	34 participants	41 participants	35 participants	110 participants
		2	1	2	5
		[1] Measure Description: number of participants with peripheral artery disease (PAD) sum of categories does not equal number of participants due to not all participants having this specific medical condition
body mass index category [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	34 participants	41 participants	35 participants	110 participants
< 30 kg/m^2		13	16	24	53
>= 30 kg/m^2		21	24	11	56
Unknown		0	1	0	1
		[1] Measure Description: body mass index <30 kg/m^2 or >= 30 kg/m^2 sum of categories does not equal number of participants due to missing data for 1 subject

Outcome Measures

1. Primary Outcome

Title	P2Y12 Reaction Units
Description	P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.
Time Frame	7 days after first randomized dose

Outcome Measure Data

Analysis Population Description

Primary Population includes all subjects who received at least 1 dose of randomized study drug and have valid PRU data at both randomization visit pre-dosing and end-of-treatment visit. A subject is considered to have valid PRU data for primary PD analyses if he/she does not have certain protocol deviations listed in Statistical Analysis Plan.

Arm/Group Title	Prasugrel Combined Groups	Ticagrelor
Arm/Group Description:	combined Prasugrel loading dose and Prasugrel maintenance dose	[Not Specified]
Overall Number of Participants Analyzed	65	33
Least Squares Mean (Standard Error); Unit of Measure: PRU (P2Y12 Reaction Units)
	95.0 (6.18)	49.0 (8.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prasugrel Combined Groups, Ticagrelor
	Comments	ANCOVA model included treatment as a main effect and pre-randomization baseline PRU as a covariate. The combined prasugrel groups were modeled as a single treatment. If the upper limit of the CI for the mean difference was not greater than 45 PRU, then the PD response to prasugrel 10 mg QD MD was deemed noninferior to that achieved by ticagrelor 90 mg BID MD.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Noninferiority was assessed using a 95% CI of the difference in mean PRU between ticagrelor and prasugrel (2 arms combined). Under the assumption of 0 difference in mean PRU between prasugrel 10 mg QD MD and ticagrelor 90 mg BID MD, a common SD of 60 PRU (based on previous DSI studies and published data), and a drop-out rate not exceeding 15%, a sample size of 105 allows for the 95% CI to stay within ± 45 PRU (non-inferiority margin) with a power of 90%.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	46.0
	Confidence Interval	(2-Sided) 95%; 24.9 to 67.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 10.66
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	P2Y12 Reaction Units
Description	P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay measured at 2, 4, 24, 48 hours after first randomized study treatment
Time Frame	2, 4, 24, 48 hours after first randomized dose

Outcome Measure Data

Analysis Population Description

Primary Population

Arm/Group Title	Prasugrel Combined Groups	Ticagrelor	Prasugrel Loading Dose	Prasugrel Maintenance Dose
Arm/Group Description:	combined Prasugrel loading dose and Prasugrel maintenance dose	[Not Specified]	prasugrel 60 mg loading dose followed by 10 mg QD for 6 days	prasugrel 10 mg QD for 7 days
Overall Number of Participants Analyzed	65	33	31	34
Least Squares Mean (Standard Error); Unit of Measure: PRU
2 hours	33.7 (3.18)	28.9 (4.24)	22.1 (4.22)	44.8 (4.15)
4 hours	41.1 (3.67)	29.3 (4.54)	24.1 (4.69)	57.0 (4.53)
24 hours	126.8 (7.57)	47.6 (8.71)	81.6 (8.86)	167.8 (8.44)
48 hours	159.3 (7.68)	38.6 (9.07)	118.3 (9.22)	199.0 (9.07)

3. Secondary Outcome

Title	Platelet Reactivity Index
Description	Platelet Reactivity Index (PRI) by the Vasodilator-Stimulated Phosphoprotein(VASP) assay 2, 4, 24, 48 hours and 7 days after first randomized study treatment. The VASP assay is an indirect, but relatively specific measure of inhibition of P2Y12-induced platelet activation. The assay quantifies the level of phosphorylation of the intracellular protein VASP, which undergoes phosphorylation when platelet P2Y12 receptors are blocked. The level of VASP phosphorylation, expressed as the PRI, represents the percentage inhibition relative to an assay baseline/maximal P2Y12-independent platelet aggregation.
Time Frame	2, 4, 24, 48 hours, 7 days after first randomized dose

Outcome Measure Data

Analysis Population Description

Primary Population

Arm/Group Title	Prasugrel Combined Groups	Ticagrelor	Prasugrel Loading Dose	Prasugrel Maintenance Dose
Arm/Group Description:	combined Prasugrel loading dose and Prasugrel maintenance dose	[Not Specified]	prasugrel 60 mg loading dose followed by 10 mg QD for 6 days	prasugrel 10 mg QD for 7 days
Overall Number of Participants Analyzed	65	33	31	34
Least Squares Mean (Standard Error); Unit of Measure: percentage PRI
2 hours post-dose	18.2 (1.37)	13.2 (1.85)	15.8 (1.94)	20.4 (1.87)
4 hours post-dose	16.3 (1.58)	14.3 (2.06)	11.4 (2.16)	20.9 (2.08)
24 hours post-dose	34.3 (2.24)	19.1 (2.71)	24.2 (2.85)	43.7 (2.74)
48 hours post-dose	48.1 (2.58)	18.7 (3.20)	38.0 (3.37)	57.7 (3.30)
7 days post-dose	33.5 (2.64)	19.8 (3.58)	38.8 (3.87)	29.1 (3.50)

4. Secondary Outcome

Title	PRU Percent Inhibition (Device-reported)
Description	PRU VerifyNow P2Y12 assay device-reported percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. The percent inhibition reported by VerifyNow device represents the percentage inhibition relative to maximal P2Y12-independent platelet aggregation achieved with the same sample in the presence of the iso-thrombin receptor activating peptide.
Time Frame	2, 4, 24, 48 hours, 7 days after first randomized dose

Outcome Measure Data

Analysis Population Description

Primary population

Arm/Group Title	Prasugrel Combined Groups	Ticagrelor	Prasugrel Loading Dose	Prasugrel Maintenance Dose
Arm/Group Description:	combined Prasugrel loading dose and Prasugrel maintenance dose	[Not Specified]	prasugrel 60 mg loading dose followed by 10 mg QD for 6 days	prasugrel 10 mg QD for 7 days
Overall Number of Participants Analyzed	65	33	31	34
Least Squares Mean (Standard Error); Unit of Measure: percent inhibition
2 hours post-dose	87.8 (1.13)	89.2 (1.53)	91.4 (1.53)	84.3 (1.51)
4 hours post-dose	84.9 (1.25)	89.6 (1.58)	90.2 (1.63)	79.8 (1.58)
24 hours post-dose	54.1 (2.68)	81.9 (3.13)	69.6 (3.18)	40.0 (3.03)
48 hours post-dose	42.3 (2.79)	85.8 (3.19)	58.3 (3.24)	26.8 (3.19)
7 days post-dose	65.5 (2.17)	81.0 (3.07)	65.6 (3.16)	65.4 (3.02)

5. Secondary Outcome

Title	PRU Percent Inhibition (Calculated)
Description	Analysis of Mean Calculated Percent Inhibition by time point Calculated percent inhibition at time point t is defined as: 100 × (baseline PRU - PRUt)/baseline PRU where baseline PRU is the VerifyNow PRU value at pre-run-in baseline and PRUt is the VerifyNow PRU value at time t.
Time Frame	2, 4, 24, 48 hours, 7 days after first randomized dose

Outcome Measure Data

Analysis Population Description

Primary population

Arm/Group Title	Prasugrel Combined Groups	Ticagrelor	Prasugrel Loading Dose	Prasugrel Maintenance Dose
Arm/Group Description:	combined Prasugrel loading dose and Prasugrel maintenance dose	[Not Specified]	prasugrel 60 mg loading dose followed by 10 mg QD for 6 days	prasugrel 10 mg QD for 7 days
Overall Number of Participants Analyzed	65	33	31	34
Least Squares Mean (Standard Error); Unit of Measure: Percent Inhibition
2 hours post-dose	88.22 (1.113)	89.73 (1.476)	92.55 (1.475)	84.15 (1.429)
4 hours post dose	85.06 (1.319)	89.26 (1.632)	91.36 (1.686)	79.35 (1.605)
24 hours post dose	53.63 (2.851)	81.86 (3.237)	71.40 (3.291)	38.01 (3.085)
48 hours post dose	41.59 (2.911)	85.06 (3.388)	57.98 (3.438)	26.20 (3.332)
7 days psot dose	64.97 (2.336)	80.69 (3.322)	64.97 (3.429)	64.97 (3.221)

6. Secondary Outcome

Title	Percentage of Subjects With High On-treatment Platelet Reactivity
Description	Percentage of subjects with High on-treatment Platelet Reactivity (HPR) defined as a) >= 208 PRU and b) >= 230 PRU by the VerifyNow P2Y12 assay and c) >50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment. A poor response of the platelets to "drug", called High Residual Platelet Reactivity (HRPR), has been incriminated to account for a recurrence of ischemic events
Time Frame	2, 4, 24, 48 hours, 7 days after first randomized dose

Outcome Measure Data

Analysis Population Description

Primary population

Arm/Group Title	Prasugrel Combined Groups	Ticagrelor	Prasugrel Loading Dose	Prasugrel Maintenance Dose
Arm/Group Description:	combined Prasugrel loading dose and Prasugrel maintenance dose	[Not Specified]	prasugrel 60 mg loading dose followed by 10 mg QD for 6 days	prasugrel 10 mg QD for 7 days
Overall Number of Participants Analyzed	65	33	31	34
Measure Type: Number; Unit of Measure: percentage of subjects
>= 208 PRU 2 hours post dose	0	0	0	0
>= 208 PRU 4 hours post dose	0	0	0	0
>= 208 PRU 24 hours post dose	17.5	0	3.3	37.5
>= 208 PRU 48 hours post dose	30.2	0	16.1	43.8
>= 208 PRU 7 days post dose	1.5	3	3.2	0
>= 230 PRU by VerifyNow P2Y12 2 hours post dose	0	0	0	0
>= 230 PRU by VerifyNow P2Y12 4 hours post dose	0	0	0	0
>= 230 PRU by VerifyNow P2Y12 24 hours post dose	14.3	0	3.3	24.2
>= 230 PRU by VerifyNow P2Y12 48 hours post dose	22.2	0	6.5	37.5
>= 230 PRU by VerifyNow P2Y12 7 days post dose	1.5	3	3.2	0
>50% PRI by VASP assay 2 hours post dose	3.5	3.3	3.6	3.4
>50% PRI by VASP assay 4 hours post dose	1.8	3.3	0	3.4
>50% PRI by VASP assay 24 hours post dose	21.3	12.9	3.4	37.5
>50% PRI by VASP assay 48 hours post dose	45	6.3	13.8	74.2
>50% PRI by VASP assay 7 days post dose	15.5	3.4	23.1	9.4

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Prasugrel Loading Dose		Prasugrel Maintenance Dose		Ticagrelor Maintenance Dose
Arm/Group Description	Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD) Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets		Prasugrel 10 mg QD MD Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet		Ticagrelor 90 mg twice-daily (BID) MD Ticagrelor Maintenance Dose : one 90mg film coated tablet
All-Cause Mortality
	Prasugrel Loading Dose		Prasugrel Maintenance Dose		Ticagrelor Maintenance Dose
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events
	Prasugrel Loading Dose		Prasugrel Maintenance Dose		Ticagrelor Maintenance Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0.00%)		0/41 (0.00%)		1/35 (2.86%)
Cardiac disorders
congestive heart failure	0/34 (0.00%)	0	0/41 (0.00%)	0	1/35 (2.86%)	1
Injury, poisoning and procedural complications
alcohol poisoning	0/34 (0.00%)	0	0/41 (0.00%)	0	1/35 (2.86%)	1
Nervous system disorders
depression	0/34 (0.00%)	0	0/41 (0.00%)	0	1/35 (2.86%)	1
Respiratory, thoracic and mediastinal disorders
pneumonia	0/34 (0.00%)	0	0/41 (0.00%)	0	1/35 (2.86%)	1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Prasugrel Loading Dose		Prasugrel Maintenance Dose		Ticagrelor Maintenance Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/34 (23.53%)		10/41 (24.39%)		12/35 (34.29%)
Cardiac disorders
angina pectoris	1/34 (2.94%)	1	0/41 (0.00%)	0	0/35 (0.00%)	0
Eye disorders
vision blurred	1/34 (2.94%)	1	0/41 (0.00%)	0	0/35 (0.00%)	0
Gastrointestinal disorders
diarrhoea	1/34 (2.94%)	1	0/41 (0.00%)	0	0/35 (0.00%)	0
periodontal disease	0/34 (0.00%)	0	1/41 (2.44%)	1	0/35 (0.00%)	0
General disorders
injection site haematoma	0/34 (0.00%)	0	0/41 (0.00%)	0	1/35 (2.86%)	1
Immune system disorders
allergic oedema	0/34 (0.00%)	0	1/41 (2.44%)	1	0/35 (0.00%)	0
Infections and infestations
upper respiratory tract infection	1/34 (2.94%)	1	0/41 (0.00%)	0	2/35 (5.71%)	2
nasopharyngitis	0/34 (0.00%)	0	0/41 (0.00%)	0	1/35 (2.86%)	1
Injury, poisoning and procedural complications
laceration	0/34 (0.00%)	0	0/41 (0.00%)	0	1/35 (2.86%)	1
muscle strain	0/34 (0.00%)	0	0/41 (0.00%)	0	1/35 (2.86%)	1
Investigations
alanine aminotransferase increased	1/34 (2.94%)	1	0/41 (0.00%)	0	0/35 (0.00%)	0
Metabolism and nutrition disorders
hypomagnesaemia	0/34 (0.00%)	0	1/41 (2.44%)	1	0/35 (0.00%)	0
Musculoskeletal and connective tissue disorders
arthralgia	0/34 (0.00%)	0	1/41 (2.44%)	1	0/35 (0.00%)	0
costochondritis	0/34 (0.00%)	0	1/41 (2.44%)	1	0/35 (0.00%)	0
pain in extremity	0/34 (0.00%)	0	1/41 (2.44%)	1	0/35 (0.00%)	0
Nervous system disorders
headache	1/34 (2.94%)	1	1/41 (2.44%)	1	1/35 (2.86%)	1
Renal and urinary disorders
renal failure	0/34 (0.00%)	0	1/41 (2.44%)	1	0/35 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
dyspnoea	0/34 (0.00%)	0	0/41 (0.00%)	0	2/35 (5.71%)	2
epistaxis	0/34 (0.00%)	0	0/41 (0.00%)	0	1/35 (2.86%)	1
Skin and subcutaneous tissue disorders
eccymosis	3/34 (8.82%)	3	5/41 (12.20%)	5	4/35 (11.43%)	4

Limitations and Caveats

[Not Specified]

More Information

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.

Consultants may not publish in any way without the prior written consent of Daiichi Sankyo Inc., which consent may be witheld by DSI in its sole discretion, any material or manuscript relating to Consultant's work hereunder and/or any information or materials that Consultant received in connection with or pursuant to this Agreement or Consultant's relationship established with DSI.

Results Point of Contact

• Name/Title: Fred Lipkin
• Organization: Daiichi Sankyo Medical Affairs
• Phone: 973-944-2216
• EMail: flipkin@dsi.com

• Responsible Party: Daiichi Sankyo, Inc.
• ClinicalTrials.gov Identifier: NCT01587651
• Other Study ID Numbers: CS747s-B-U4003
• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Results First Submitted: February 11, 2014
• Results First Posted: April 29, 2014
• Last Update Posted: January 9, 2019