PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

This study has been completed.

Study NCT00355615 Information provided by AstraZeneca

First Received on July 20, 2006. Last Updated on August 29, 2011 History of Changes

Results First Received: May 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Familial Hypercholesterolemia
Interventions:	Drug: Rosuvastatin Drug: Placebo

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
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

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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
Age [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 [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

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1. Primary:

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 ]

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2. Secondary:

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 ]

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3. Secondary:

Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment [ Time Frame: 12 weeks ]

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4. Secondary:

Percent Change in HDL-C [ Time Frame: After 12 weeks of treatment ]

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5. Secondary:

Percent Change in Non-HDL-C at 12 Weeks [ Time Frame: After 12 weeks of treatment ]

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6. Secondary:

Percent Change in Triglycerides (TG) [ Time Frame: After 12 weeks of treatment ]

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7. Secondary:

Percent Change in Total Cholesterol (TC) [ Time Frame: After 12 weeks of treatment ]

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8. Secondary:

Percent Change in Apolipoprotein A-1 (ApoA-1) [ Time Frame: After 12 weeks of treatment ]

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9. Secondary:

Percent Change in Apolipoprotein B (ApoB) [ Time Frame: After 12 weeks of treatment ]

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10. Secondary:

Percent Change in ApoB/ApoA-1 [ Time Frame: After 12 weeks of treatment ]

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11. Secondary:

Percent Change in LDL-C/HDL-C [ Time Frame: After 12 week of treatment ]

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12. Secondary:

Percent Change in TC/HDL-C [ Time Frame: After 12 weeks of treatment ]

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13. Secondary:

Percent Change in Non-HDL-C/HDL-C [ Time Frame: After 12 weeks of treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

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

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

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: AZTrial_Results_Posting@astrazeneca.com

No publications provided by AstraZeneca

Publications automatically indexed to this study:

Avis HJ, Hutten BA, Gagné C, Langslet G, McCrindle BW, Wiegman A, Hsia J, Kastelein JJ, Stein EA. Efficacy and safety of rosuvastatin therapy for children with familial hypercholesterolemia. J Am Coll Cardiol. 2010 Mar 16;55(11):1121-6.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00355615 History of Changes
Other Study ID Numbers:	D3561C00087, PLUTO
Study First Received:	July 20, 2006
Results First Received:	May 29, 2009
Last Updated:	August 29, 2011
Health Authority:	United States: Food and Drug Administration