IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654446
First received: April 3, 2008
Last updated: March 13, 2009
Last verified: March 2009
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Purpose
The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa & Type IIb Dyslipidaemia
| Condition | Intervention | Phase |
|---|---|---|
|
Fredrickson Type IIa & Type IIb Dyslipidaemia |
Drug: Rosuvastatin Drug: Simvastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
hypercholesterolemia
MedlinePlus related topics:
Cholesterol
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Development of Proteinuria [ Time Frame: 2 weekly ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Renal effects of rosuvastatin and simvastatin [ Time Frame: 2 weekly ] [ Designated as safety issue: No ]
- Low density lipoproteins cholesterol levels [ Time Frame: 2 weekly ] [ Designated as safety issue: No ]
- Safety: adverse events & abnormal laboratory markers [ Time Frame: 2 weekly ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 442 |
| Study Start Date: | September 2002 |
| Study Completion Date: | April 2004 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Rosuvastatin
|
Drug: Rosuvastatin
Other Name: Crestor
|
|
Active Comparator: 2
Simvastatin
|
Drug: Simvastatin
Other Name: Zocor
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Fasting low density lipoprotein level as defined by the protocol.
- Fasting triglyceride level as defined by the protocol.
Exclusion Criteria:
- The use of lipid lowering drugs or dietary supplements after Visit 1.
- Active arterial disease eg Unstable angina, or recent arterial surgery
- Blood creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.
- Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Michael Cressman - Medical Science Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00654446 History of Changes |
| Other Study ID Numbers: | 4522IL/0099 |
| Study First Received: | April 3, 2008 |
| Last Updated: | March 13, 2009 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Israel: Israeli Health Ministry Pharmaceutical Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency South Africa: Medicines Control Council |
Keywords provided by AstraZeneca:
|
Cholesterol low density lipoproteins dyslipidaemia Rosuvastatin Crestor |
Simvastatin Zocor Renal kidney |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipoproteinemia Type II Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias Simvastatin |
Rosuvastatin Lipid Regulating Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013