Evaluate Efficacy and Safety of Saxagliptin in Adult Patients with Type 2 Diabetes inadequate glycemic control

Study identifier:D1680C00005

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase III study to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control with Diet and Exercise.

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

Study drug

Saxagliptin, Placebo

Sex

All

Actual Enrollment

568

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jun 2008

Primary Completion Date: 01 Oct 2009

Study Completion Date: 01 Oct 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2011 by AstraZeneca Pharmaceuticals

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

Location

Research Site

HEFEI, Anhui, China

Location

Research Site

BEIJING, CHINA, China

Location

Research Site

CHONGQING, CHINA, China

Location

Research Site

FUZHOU, Fujian, China

Location

Research Site

GUANGZHOU, Guangdong, China

Location

Research Site

Shijiazhuang, Hebei, China

Location

Research Site

CHANGSHA, Hunan, China

Location

Research Site

NANJING, Jiangsu, China

Arms	Assigned Interventions
Experimental: Saxagliptin 5mg	Drug: Saxagliptin 5mg, oral tablet, once daily for 24 weeks Other Name: Onglyza
Placebo Comparator: Placebo	Drug: Placebo oral tablet, once daily for 24 weeks

Participant Flow

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
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Participant Flow: Overall Study

	Saxagliptin 5 mg	Placebo
STARTED	284^[1]	284^[2]
COMPLETED	262^[3]	248^[4]
NOT COMPLETED	22	36
Adverse Event	0	2
Incorrect enrollment	0	2
Study specific discontinuation criteria	3	4
Withdrawal by Subject	11	23
Lost to Follow-up	6	1
Severe non-compliance to protocol	1	2
Safety reasons	0	2
Death	1	0

[1]	Randomized and treated
[2]	Randomized and treated
[3]	Completed 24 Weeks of treatment
[4]	Completed 24 Weeks of treatment

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Baseline Measures

	Saxagliptin 5 mg	Placebo	Total
Number of Participants [units: Participants]	284	284	568
Age Continuous [units: Years] Mean ± Standard Deviation	51.23 ± 10.04	51.57 ± 10.34	51.4 ± 10.18
Gender, Male/Female [units: Participants]
Female	124	129	253
Male	160	155	315

Outcome Measures

1. Primary Outcome Measure: Absolute change from baseline to week 24 in glycosylated haemoglobin A1c (HbA1c) [ Time Frame: Baseline , Week 24 ]

Measure Type	Primary
Measure Name	Absolute change from baseline to week 24 in glycosylated haemoglobin A1c (HbA1c)
Measure Description	Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.
Time Frame	Baseline , Week 24
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.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.

Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Measured Values

	Saxagliptin 5 mg	Placebo
Number of Participants Analyzed [units:participants]	277	274
Absolute change from baseline to week 24 in glycosylated haemoglobin A1c (HbA1c) [units: percent] Mean (Standard Error)
Baseline	8.15 (0.050)	8.14 (0.050)
Week 24	7.25 (0.063)	7.75 (0.076)
Adjusted Mean Change from Baseline	-0.84 (0.067)	-0.34 (0.065)

Statistical Analysis 1 for Absolute change from baseline to week 24 in glycosylated haemoglobin A1c (HbA1c)

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.0001
Mean Difference (Net)^[5]	-0.50
Standard Error of the mean	± 0.079
95% Confidence Interval	( -0.65 to -0.34 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	*adjusted for baseline HbA1c
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

2. Secondary Outcome Measure: Absolute change (mmol/L) from baseline to week 24 in fasting plasma glucose (FPG) [ Time Frame: Baseline, Week 24 ]

Measure Type	Secondary
Measure Name	Absolute change (mmol/L) from baseline to week 24 in fasting plasma glucose (FPG)
Measure Description	Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.
Time Frame	Baseline, Week 24
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.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.

Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Measured Values

	Saxagliptin 5 mg	Placebo
Number of Participants Analyzed [units:participants]	280	279
Absolute change (mmol/L) from baseline to week 24 in fasting plasma glucose (FPG) [units: mmol/L] Mean (Standard Error)
Baseline	9.15 (0.125)	9.05 (0.141)
week 24	8.10 (0.129)	8.77 (0.163)
Adjusted mean change from Baseline	-0.90 (0.144)	-0.17 (0.141)

Statistical Analysis 1 for Absolute change (mmol/L) from baseline to week 24 in fasting plasma glucose (FPG)

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.0001
Mean Difference (Net)^[5]	-0.73
Standard Error of the mean	± 0.170
95% Confidence Interval	( -1.06 to -0.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	*adjusted for baseline FPG
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

3. Secondary Outcome Measure: Absolute change (mg/dL) from baseline to week 24 in fasting plasma glucose (FPG) [ Time Frame: Baseline, Week 24 ]

Measure Type	Secondary
Measure Name	Absolute change (mg/dL) from baseline to week 24 in fasting plasma glucose (FPG)
Measure Description	Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.
Time Frame	Baseline, Week 24
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.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.

Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Measured Values

	Saxagliptin 5 mg	Placebo
Number of Participants Analyzed [units:participants]	280	279
Absolute change (mg/dL) from baseline to week 24 in fasting plasma glucose (FPG) [units: mg/dL] Mean (Standard Error)
Baseline	164.85 (2.253)	163.03 (2.543)
Week 24	145.97 (2.317)	158.04 (2.942)
Adjusted mean change from Baseline	-16.13 (2.586)	-3.01 (2.544)

Statistical Analysis 1 for Absolute change (mg/dL) from baseline to week 24 in fasting plasma glucose (FPG)

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.0001
Mean Difference (Net)^[5]	-13.12
Standard Error of the mean	± 3.053
95% Confidence Interval	( -19.12 to -7.13 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	*adjusted for baseline FPG
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

4. Secondary Outcome Measure: Absolute change (mmol*min/L) from baseline to week 24 in area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during mixed meal (instant noodles) tolerance tests (MMTT) in all MMTT participants [ Time Frame: Baseline , Week 24 ]

Measure Type	Secondary
Measure Name	Absolute change (mmol*min/L) from baseline to week 24 in area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during mixed meal (instant noodles) tolerance tests (MMTT) in all MMTT participants
Measure Description	Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication
Time Frame	Baseline , Week 24
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.
MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.

Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Measured Values

	Saxagliptin 5 mg	Placebo
Number of Participants Analyzed [units:participants]	94	77
Absolute change (mmolmin/L) from baseline to week 24 in area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during mixed meal (instant noodles) tolerance tests (MMTT) in all MMTT participants [units: mmolmin/L] Mean (Standard Error)
Baseline	2474 (46.9)	2506 (64.9)
Week 24	2063 (41.1)	2262 (57.6)
Adjusted mean change from Baseline	-417 (36.5)	-235 (40.4)

Statistical Analysis 1 for Absolute change (mmol*min/L) from baseline to week 24 in area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during mixed meal (instant noodles) tolerance tests (MMTT) in all MMTT participants

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.001
Median Difference (Net)^[5]	-182
Standard Error of the mean	± 54.4
95% Confidence Interval	( -289 to -74 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	*adjusted for baseline PPG AUC
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

5. Secondary Outcome Measure: Absolute change (mg*min/dL) from baseline to week 24 in area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during mixed meal (instant noodles) tolerance tests (MMTT) in all MMTT participants [ Time Frame: Baseline , Week 24 ]

Measure Type	Secondary
Measure Name	Absolute change (mg*min/dL) from baseline to week 24 in area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during mixed meal (instant noodles) tolerance tests (MMTT) in all MMTT participants
Measure Description	Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication
Time Frame	Baseline , Week 24
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.
MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.

Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Measured Values

	Saxagliptin 5 mg	Placebo
Number of Participants Analyzed [units:participants]	94	77
Absolute change (mgmin/dL) from baseline to week 24 in area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during mixed meal (instant noodles) tolerance tests (MMTT) in all MMTT participants [units: mgmin/dL] Mean (Standard Error)
Baseline	44586 (844.8)	45146 (1170.5)
week 24	37166 (739.6)	40751 (1036.6)
Adjusted mean change from Baseline	-7534 (657.4)	-4255 (726.4)

Statistical Analysis 1 for Absolute change (mg*min/dL) from baseline to week 24 in area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during mixed meal (instant noodles) tolerance tests (MMTT) in all MMTT participants

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.001
Mean Difference (Net)^[5]	-3280
Standard Error of the mean	± 980.0
95% Confidence Interval	( -5214 to -1345 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	*adjusted for baseline PPG AUC
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

6. Secondary Outcome Measure: Proportion of patients achieving a therapeutic glycemic response defined as HbA1c <7.0% at week 24 [ Time Frame: Baseline, Week 24 ]

Measure Type	Secondary
Measure Name	Proportion of patients achieving a therapeutic glycemic response defined as HbA1c <7.0% at week 24
Measure Description	Proportion of participants (expressed in percentage of total participants) achieving HbA1c < 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication
Time Frame	Baseline, Week 24
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.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.

Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Measured Values

	Saxagliptin 5 mg	Placebo
Number of Participants Analyzed [units:participants]	277	274
Proportion of patients achieving a therapeutic glycemic response defined as HbA1c <7.0% at week 24 [units: Percentage of Participants]	45.8	28.8

Statistical Analysis 1 for Proportion of patients achieving a therapeutic glycemic response defined as HbA1c <7.0% at week 24

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.0001
Median Difference (Net)^[5]	17.0
95% Confidence Interval	( 8.9 to 24.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Serious Adverse Events

Saxagliptin 5 mg

Placebo

Total, serious adverse events

# participants affected / at risk

8/284 (2.82%)

4/284 (1.41%)

Cardiac disorders

Angina Unstable¹,^†

# participants affected / at risk

2/284 (0.70%)

0/284 (0.00%)

Cardiac disorders

Myocardial Infarction¹,^†

# participants affected / at risk

1/284 (0.35%)

0/284 (0.00%)

Gastrointestinal disorders

Intestinal Obstruction¹,^†

# participants affected / at risk

1/284 (0.35%)

0/284 (0.00%)

Injury, poisoning and procedural complications

Anal Injury¹,^†

# participants affected / at risk

1/284 (0.35%)

0/284 (0.00%)

Musculoskeletal and connective tissue disorders

Osteoarthritis¹,^†

# participants affected / at risk

1/284 (0.35%)

0/284 (0.00%)

Nervous system disorders

Cerebrovascular Accident¹,^†

# participants affected / at risk

1/284 (0.35%)

0/284 (0.00%)

Respiratory, thoracic and mediastinal disorders

Pleural Effusion¹,^†

# participants affected / at risk

1/284 (0.35%)

0/284 (0.00%)

Respiratory, thoracic and mediastinal disorders

Asthma¹,^†

# participants affected / at risk

0/284 (0.00%)

1/284 (0.35%)

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

0/284 (0.00%)

1/284 (0.35%)

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

0/284 (0.00%)

2/284 (0.70%)

Infections and infestations

Renal Abscess¹,^†

# participants affected / at risk

0/284 (0.00%)

1/284 (0.35%)

Renal and urinary disorders

Hydronephrosis¹,^†

# participants affected / at risk

0/284 (0.00%)

1/284 (0.35%)

Renal and urinary disorders

Nephrolithiasis¹,^†

# participants affected / at risk

0/284 (0.00%)

1/284 (0.35%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 12
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Other Adverse Events

Saxagliptin 5 mg

Placebo

Total, other (not including serious) adverse events

# participants affected / at risk

18/284 (6.34%)

22/284 (7.75%)

Infections and infestations

Upper Respiratory Tract Infection¹,^†

# participants affected / at risk

18/284 (6.34%)

22/284 (7.75%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 12
2	Term from vocabulary,

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: The Principal Investigator undertakes to provide AstraZeneca as soon as possible with preliminary data and drafts of proposed publications and disclosures, whether oral or in writing, and as soon as available, with the proposed final manuscript. AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed

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:	Gerard Lynch
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=282&filename=CSR-D1680C00005.pdf
Download
CSR-D1680C00005.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Peter Öhman

AstraZeneca, Wilmington, USA

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=282&filename=CSR-D1680C00005.pdf

CSR-D1680C00005.pdf

Trial Results Summaries