8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00739999

First received: August 21, 2008

Last updated: August 19, 2010

Last verified: June 2009

History of Changes

Results First Received: March 15, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Parallel Assignment; Masking: Open Label
Condition:	Pediatric Heterozygous Hypercholesterolemia
Intervention:	Drug: Atorvastatin

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
Subjects were enrolled at 3 medical centers and participated in the study between 02 December 2008 and 13 May 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty-five subjects were screened, and 39 subjects were assigned to study treatment.

Reporting Groups

	Description
Atorvastatin (5 mg, 10 mg): Tanner Stage 1	Age 6 - 10 years, at Tanner Stage 1. Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target low-density lipoprotein cholesterol (LDL-C) was not attained.
Atorvastatin (10 mg, 20 mg): Tanner Stage 2+	Age 10 - 17 years, at Tanner Stage 2+. Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained.

Participant Flow: Overall Study

	Atorvastatin (5 mg, 10 mg): Tanner Stage 1	Atorvastatin (10 mg, 20 mg): Tanner Stage 2+
STARTED	15	24
COMPLETED	15	24
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Atorvastatin (5 mg, 10 mg): Tanner Stage 1	Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
Atorvastatin (10 mg, 20 mg): Tanner Stage 2+	Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
Total	Total of all reporting groups

Baseline Measures

	Atorvastatin (5 mg, 10 mg): Tanner Stage 1	Atorvastatin (10 mg, 20 mg): Tanner Stage 2+	Total
Number of Participants [units: participants]	15	24	39
Age, Customized [units: participants]
6-8 years	7	0	7
9-10 years	6	3	9
11-14 years	2	14	16
15-17 years	0	7	7
Gender [units: participants]
Female	7	12	19
Male	8	12	20

Outcome Measures

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1. Primary:

Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F) [ Time Frame: Week 2, Week 4, Week 6, Week 8 ]

Show Outcome Measure 1

2. Primary:

Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F) [ Time Frame: Week 2, Week 4, Week 6, Week 8 ]

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3. Secondary:

Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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4. Secondary:

Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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5. Secondary:

Absolute Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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6. Secondary:

Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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7. Secondary:

Absolute Change From Baseline in Triglycerides (TG) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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8. Secondary:

Percent Change From Baseline in Triglycerides (TG) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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9. Secondary:

Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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10. Secondary:

Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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11. Secondary:

Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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12. Secondary:

Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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13. Secondary:

Absolute Change From Baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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14. Secondary:

Percent Change From Baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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15. Secondary:

Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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16. Secondary:

Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]

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17. Secondary:

Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 [ Time Frame: Baseline, Week 8 ]

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18. Secondary:

Percent Change From Baseline in Flow-Mediated Dilatation at Week 8 [ Time Frame: Baseline, Week 8 ]

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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. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00739999 History of Changes
Other Study ID Numbers:	A2581172
Study First Received:	August 21, 2008
Results First Received:	March 15, 2010
Last Updated:	August 19, 2010
Health Authority:	Canada: Ethics Review Committee

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