PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

Study identifier:D3561C00087

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A phase IIIb, efficacy, and safety study of rosuvastatin in children 10-17 years of age with heterozygous familial hypercholesterolemia: a 12-week, double-blind, randomized, multicenter, placebo-controlled study with a 40-week, open-label, follow-up

Medical condition

Familial Hypercholesterolemia

Phase

Phase 3

Healthy volunteers

Study drug

Rosuvastatin, Placebo

Sex

All

Actual Enrollment

173

Study type

Interventional

Age

10 Years - 17 Years

Date

Study Start Date: 01 Jul 2006

Primary Completion Date: 01 Jul 2008

Study Completion Date: 01 Jul 2008

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

Inclusion and exclusion criteria

Location

Research Site

Cincinnati, OH, United States

Location

Research Site

Wexford, PA, United States

Location

Research Site

Los Angeles, CA, United States

Location

Research Site

Hamilton, ON, Canada

Location

Research Site

Hyde Park, NY, United States

Location

Research Site

Laval, Quebec, Canada

Location

Research Site

Chicoutimi, Quebec, Canada

Location

Research Site

Sherbrook, Quebec, Canada

Arms	Assigned Interventions
Active Comparator: rosuva 5 rosuvastatin 5 mg	Drug: Rosuvastatin oral Other Name: Nexium
Active Comparator: rosuva 10 rosuvastatin 10 mg	Drug: Rosuvastatin oral Other Name: Nexium
Active Comparator: rosuva 20 rosuvastatin 20 mg	Drug: Rosuvastatin oral Other Name: Nexium
Placebo Comparator: Placebo Placebo	Drug: Placebo oral
Other: rosuva ol rosuvastatin open label	Drug: Rosuvastatin oral Other Name: Nexium

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One-hundred male and female (Tanner stages II to V, at least 1 year post-menarche) children and adolescents (aged 10 to 17 years with Heterozygous familial hypercholesterolemia were randomized into the study, from 20 sites located in The United States (3 sites), The Netherlands (7 sites), Norway (1 site), Spain (3 sites), and Canada (6 sites).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients entered a 6 week dietary lead-in/drug washout period. Eligible patients were then randomly assigned to double-blind treatment with rosuvastatin 5 mg, 10 mg, 20 mg, or matching placebo, administered orally once daily for 12 weeks.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo
rosuva ol	rosuvastatin open label

Participant Flow for 2 periods

Period 1: Randomized Double Blind Period

	rosuva 5	rosuva 10	rosuva 20	placebo	rosuva ol
STARTED	42	44	45	46	0^[1]
COMPLETED	41^[2]	44	44^[3]	45^[4]	0
NOT COMPLETED	1	0	1	1	0
Adverse Event	1	0	0	0	0
Protocol Violation	0	0	1	1	0

[1]	open label phase followed the randomized phase
[2]	1 dropped out due to adverse event
[3]	45 were randomized but 1 never received drug
[4]	1 dropped out due to an adverse event

Period 2: 40-week rosuvastatin open label period

	rosuva 5	rosuva 10	rosuva 20	placebo	rosuva ol
STARTED	0	0	0	0	173
COMPLETED	0	0	0	0	164
NOT COMPLETED	0	0	0	0	9
Adverse Event	0	0	0	0	4
Protocol Violation	0	0	0	0	1
Withdrawal by Subject	0	0	0	0	3
investigational site closed	0	0	0	0	1

Baseline Characteristics

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

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Baseline Measures

	rosuva 5	rosuva 10	rosuva 20	placebo	Total
Number of Participants [units: Participants]	42	44	45	46	177.0
Age Continuous [units: years] Mean ( Full Range )	14.1 (10 to 17)	14.5 (11 to 17)	14.2 (11 to 17)	14.3 (10 to 17)	14.3 (10 to 17)
Gender, Male/Female [units: Participants]
Female	26	25	22	24	97
Male	16	19	23	22	80
Baseline low-density lipoprotein cholesterol (LDL-C) [units: mg/dL] Mean ± Standard Deviation	237.70 ± 55.06	229.10 ± 44.70	237.40 ± 47.80	229.00 ± 43.13	233.3 ± 10.0

Outcome Measures

1. Primary Outcome Measure: Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day 0) to the end of the 12-week double-blind treatment phase [ Time Frame: 12 weeks ]

Measure Type	Primary
Measure Name	Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day 0) to the end of the 12-week double-blind treatment phase
Measure Description	Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100
Time Frame	12 weeks
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	44	44	46
Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day 0) to the end of the 12-week double-blind treatment phase [units: percentage] Mean (Standard Deviation)	-38.5 (11.38)	-44.4 (12.15)	-50.2 (13.3)	-0.5 (13.18)

No statistical analysis provided for Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day 0) to the end of the 12-week double-blind treatment phase

2. Secondary Outcome Measure: Percent change in LDL-C and other lipid parameters from baseline to Week 6, and at end of double-blind dose treatment phase (Week 12) [ Time Frame: 6 weeks ]

Measure Type	Secondary
Measure Name	Percent change in LDL-C and other lipid parameters from baseline to Week 6, and at end of double-blind dose treatment phase (Week 12)
Measure Description	Percent change from baseline in LDL-C after six week of treatment
Time Frame	6 weeks
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	44	44	46
Percent change in LDL-C and other lipid parameters from baseline to Week 6, and at end of double-blind dose treatment phase (Week 12) [units: percentage] Mean (Standard Deviation)	-40.3 (12.22)	-45.2 (11.15)	-50.0 (11.42)	-0.6 (13.63)

No statistical analysis provided for Percent change in LDL-C and other lipid parameters from baseline to Week 6, and at end of double-blind dose treatment phase (Week 12)

3. Secondary Outcome Measure: Percent control rate based on achievement of LDL-C target of <110 mg/dL during double-blind dose treatment [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Name	Percent control rate based on achievement of LDL-C target of <110 mg/dL during double-blind dose treatment
Measure Description	Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group
Time Frame	12 weeks
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	44	44	46
Percent control rate based on achievement of LDL-C target of <110 mg/dL during double-blind dose treatment [units: Percent of Participants]	11.9	40.9	40.9	0.0

No statistical analysis provided for Percent control rate based on achievement of LDL-C target of <110 mg/dL during double-blind dose treatment

4. Secondary Outcome Measure: Percent change in HDL-C [ Time Frame: After 12 weeks of treatment ]

Measure Type	Secondary
Measure Name	Percent change in HDL-C
Measure Description	Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment
Time Frame	After 12 weeks of treatment
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	44	44	46
Percent change in HDL-C [units: percent change] Mean (Standard Deviation)	4.5 (15.53)	10.1 (14.19)	8.9 (14.11)	7.6 (17.89)

No statistical analysis provided for Percent change in HDL-C

5. Secondary Outcome Measure: Percent change in Non-HDL-C at 12 weeks [ Time Frame: After 12 weeks of treatment ]

Measure Type	Secondary
Measure Name	Percent change in Non-HDL-C at 12 weeks
Measure Description	Percent change in non-HDL-C at 12 weeks
Time Frame	After 12 weeks of treatment
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	44	44	46
Percent change in Non-HDL-C at 12 weeks [units: percent change] Mean (Standard Deviation)	-36.3 (9.98)	-42.8 (11.50)	-47.7 (13.50)	-0.8 (11.89)

No statistical analysis provided for Percent change in Non-HDL-C at 12 weeks

6. Secondary Outcome Measure: Percent change in triglycerides (TG) [ Time Frame: After 12 weeks of treatment ]

Measure Type	Secondary
Measure Name	Percent change in triglycerides (TG)
Measure Description	Percent change in tryglycerides (TG) after 12 weeks of treatment
Time Frame	After 12 weeks of treatment
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	44	44	46
Percent change in triglycerides (TG) [units: percent change] Mean (Standard Deviation)	2.6 (49.07)	-14.2 (29.66)	-7.9 (55.88)	3.4 (48.27)

No statistical analysis provided for Percent change in triglycerides (TG)

7. Secondary Outcome Measure: Percent change in total cholesterol (TC) [ Time Frame: After 12 weeks of treatment ]

Measure Type	Secondary
Measure Name	Percent change in total cholesterol (TC)
Measure Description	Percent change from baseline in total cholesteral after 12 weeks of treatment
Time Frame	After 12 weeks of treatment
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	44	44	46
Percent change in total cholesterol (TC) [units: percent change] Mean (Standard Deviation)	-30.0 (9.63)	-34.1 (9.5)	-38.9 (12.08)	0.2 (10.53)

No statistical analysis provided for Percent change in total cholesterol (TC)

8. Secondary Outcome Measure: Percent change in apolipoprotein A-1 (ApoA-1) [ Time Frame: After 12 weeks of treatment ]

Measure Type	Secondary
Measure Name	Percent change in apolipoprotein A-1 (ApoA-1)
Measure Description	Percent change in ApoA-1 after 12 weeks of treatment
Time Frame	After 12 weeks of treatment
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	43	43	46
Percent change in apolipoprotein A-1 (ApoA-1) [units: mean percent change] Mean (Standard Deviation)	2.3 (9.69)	4.3 (9.85)	3.9 (10.68)	3.6 (15.59)

No statistical analysis provided for Percent change in apolipoprotein A-1 (ApoA-1)

9. Secondary Outcome Measure: Percent change in apolipoprotein B (ApoB) [ Time Frame: After 12 weeks of treatment ]

Measure Type	Secondary
Measure Name	Percent change in apolipoprotein B (ApoB)
Measure Description	Percent change in ApoB after 12 weeks of treatment
Time Frame	After 12 weeks of treatment
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	43	43	46
Percent change in apolipoprotein B (ApoB) [units: mean percent change] Mean (Standard Deviation)	-32.1 (9.13)	-37.8 (11.75)	-40.7 (13.91)	-1.5 (14.67)

No statistical analysis provided for Percent change in apolipoprotein B (ApoB)

10. Secondary Outcome Measure: Percent change in ApoB/ApoA-1 [ Time Frame: After 12 weeks of treatment ]

Measure Type	Secondary
Measure Name	Percent change in ApoB/ApoA-1
Measure Description	Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment
Time Frame	After 12 weeks of treatment
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	43	43	46
Percent change in ApoB/ApoA-1 [units: mean percent change] Mean (Standard Deviation)	-33.1 (9.99)	-40.0 (12.06)	-42.8 (12.23)	-3.4 (16.70)

No statistical analysis provided for Percent change in ApoB/ApoA-1

11. Secondary Outcome Measure: Percent change in LDL-C/HDL-C [ Time Frame: After 12 week of treatment ]

Measure Type	Secondary
Measure Name	Percent change in LDL-C/HDL-C
Measure Description	Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment
Time Frame	After 12 week of treatment
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	44	44	46
Percent change in LDL-C/HDL-C [units: mean percent change] Mean (Standard Deviation)	-40.4 (11.36)	-48.6 (13.26)	-53.6 (12.85)	-5.5 (17.98)

No statistical analysis provided for Percent change in LDL-C/HDL-C

12. Secondary Outcome Measure: Percent change in TC/HDL-C [ Time Frame: After 12 weeks of treatment ]

Measure Type	Secondary
Measure Name	Percent change in TC/HDL-C
Measure Description	Percent change in the ratio of TC/HDL-C after 12 weeks of treatment
Time Frame	After 12 weeks of treatment
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	44	44	46
Percent change in TC/HDL-C [units: mean percent change] Mean (Standard Deviation)	-32.1 (10.72)	-39.3 (11.55)	-43.2 (11.76)	-5.2 (15.03)

No statistical analysis provided for Percent change in TC/HDL-C

13. Secondary Outcome Measure: Percent change in non-HDL-C/HDL-C [ Time Frame: After 12 weeks of treatment ]

Measure Type	Secondary
Measure Name	Percent change in non-HDL-C/HDL-C
Measure Description	Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment
Time Frame	After 12 weeks of treatment
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.
Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo

Measured Values

	rosuva 5	rosuva 10	rosuva 20	placebo
Number of Participants Analyzed [units:participants]	42	44	44	46
Percent change in non-HDL-C/HDL-C [units: mean percent change] Mean (Standard Deviation)	-37.9 (12.12)	-47.1 (13.12)	-51.2 (13.18)	-5.8 (17.63)

No statistical analysis provided for Percent change in non-HDL-C/HDL-C

Serious Adverse Events

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

Reporting Groups

	Description
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo
rosuva ol	rosuvastatin open label

Serious Adverse Events

rosuva 5

rosuva 10

rosuva 20

placebo

rosuva ol

Total, serious adverse events

# participants affected / at risk

0/---

1/---

2/---

Infections and infestations

Appendicitis¹,^†

# participants affected / at risk

0/---

1/---

Skin and subcutaneous tissue disorders

Rash Vesicular¹,^†

# participants affected / at risk

0/---

1/---

Eye disorders

Vision Blurred¹,^†

# participants affected / at risk

0/---

1/---

0/---

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.0
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
rosuva 5	rosuvastatin 5 mg
rosuva 10	rosuvastatin 10 mg
rosuva 20	rosuvastatin 20 mg
placebo	placebo
rosuva ol	rosuvastatin open label

Other Adverse Events

rosuva 5

rosuva 10

rosuva 20

placebo

rosuva ol

Total, other (not including serious) adverse events

# participants affected / at risk

12/---

14/---

17/---

75/---

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

1/---

0/---

9/---

Nervous system disorders

Headache¹,^†

# participants affected / at risk

6/---

7/---

9/---

29/---

Infections and infestations

Influenza¹,^†

# participants affected / at risk

2/---

0/---

4/---

14/---

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

3/---

7/---

5/---

36/---

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

2/---

0/---

2/---

10/---

Gastrointestinal disorders

Tonsillitis¹,^†

# participants affected / at risk

0/---

3/---

1/---

2/---

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 11.0
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:

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
None

Results Point of Contact

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

Documents available

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Download
CSR-D3561C00087.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Crestor Medical Science Director

AstraZeneca

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=323&filename=CSR-D3561C00087.pdf

CSR-D3561C00087.pdf

Trial Results Summaries