PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

NCT00355615 | Completed Phase 3 Results

• 2 other identifiers: D3561C00087PLUTO
• Study Type: interventional
• Target: 173
• Locations: 5 countries
• Sites: 20

Brief Summary

The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind treatment period.

Conditions

Familial Hypercholesterolemia

Keywords

Heterozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase

  Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value \* 100

  12 weeks

Secondary Outcomes (12)

• 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)

  6 weeks

• Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment

  12 weeks

• Percent Change in HDL-C

  After 12 weeks of treatment

• Percent Change in Non-HDL-C at 12 Weeks

  After 12 weeks of treatment

• Percent Change in Triglycerides (TG)

  After 12 weeks of treatment

Study Arms (5)

rosuva 5

ACTIVE COMPARATOR

rosuvastatin 5 mg

Drug: Rosuvastatin

rosuva 10

ACTIVE COMPARATOR

rosuvastatin 10 mg

Drug: Rosuvastatin

rosuva 20

ACTIVE COMPARATOR

rosuvastatin 20 mg

Drug: Rosuvastatin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

rosuva ol

OTHER

rosuvastatin open label

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

oral

Also known as: Nexium

rosuva 10; rosuva 20; rosuva 5; rosuva ol

Placebo DRUG

oral

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)

You may not qualify if:

• Certain medical conditions and lab test results
• History of a reaction to rosuvastatin or other statin drugs
• Use of specified disallowed medications

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (20)

Research Site

Los Angeles, California, United States

Location

Research Site

Hyde Park, New York, United States

Location

Research Site

Cincinnati, Ohio, United States

Location

Research Site

Wexford, Pennsylvania, United States

Location

Research Site

Hamilton, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Chicoutimi, Quebec, Canada

Location

Research Site

Laval, Quebec, Canada

Location

Research Site

Sherbrook, Quebec, Canada

Location

Research SIte

Amsterdam, Netherlands

Location

Research Site

Eindhoven, Netherlands

Location

Research Site

Groningen, Netherlands

Location

Research Site

Hoorn, Netherlands

Location

Research Site

Rotterdam, Netherlands

Location

Research Site

Utrecht, Netherlands

Location

Research SIte

Waalwijk, Netherlands

Location

Research Site

Oslo, Norway

Location

Research Site

Córdoba, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Reus, Spain

Location

Related Publications (1)

• Avis HJ, Hutten BA, Gagne 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. doi: 10.1016/j.jacc.2009.10.042.

  PMID: 20223367 DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Rosuvastatin Calcium; Esomeprazole

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

AZTrial_Results_Posting@astrazeneca.com

Study Officials

• Crestor Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2006
• First Posted: July 24, 2006
• Study Start: July 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 31, 2011
• Results First Posted: July 20, 2009

Record last verified: 2011-08

Locations

US (4); CA (5); ES (3); NO (1); NL (7)