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NCT00171236 Clinical Trial

Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Mixed Dyslipidemia Clinical Trial

Official title:
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171236
Other study ID # CXUO320B2301
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated November 7, 2011
Start date October 2001
Est. completion date March 2005

Study information
Verified date September 2005
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medicines Evaluation Board (MEB)United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date March 2005
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 16 Years
Eligibility Inclusion Criteria:

- 10-16 years old Heterozygous familial hypercholesterolemia

Exclusion Criteria:

- Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study

Other protocol defined inclusion and exclusion criteria may apply

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fluvastatin

Locations
Country Name City State
Switzerland Novartis Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

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Completed NCT00300482 - Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood Phase 3
Completed NCT00300469 - Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood Phase 3
Completed NCT00300456 - Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood Phase 3
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Terminated NCT01274559 - Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133) Phase 3
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Completed NCT00491530 - A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia Phase 3
Completed NCT00136799 - Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia Phase 3
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