Skip to main content
OpenTrials
Completed

NCT Number: NCT00654446

IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fredrickson Type IIa & Type IIb Dyslipidaemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

Other names: Crestor

simvastatin

Drug

Other names: Zocor

Primary outcomes

  1. Development of Proteinuria

    Time frame: 2 weekly

Secondary outcomes

  1. Renal effects of rosuvastatin and simvastatin

    Time frame: 2 weekly

  2. Low density lipoproteins cholesterol levels

    Time frame: 2 weekly

  3. Safety: adverse events & abnormal laboratory markers

    Time frame: 2 weekly

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2004
First posted
Apr 8, 2008
Registry last updated
Mar 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.