Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg

NCT00653445 | Completed Phase 3

• 1 other identifier: D3569C00006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.

Conditions

Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis

Keywords

Low density lipoproteins; Hypercholesterolemia; Coronary Heart Disease; Rosuvastatin; Crestor; Ezetimibe

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6

Secondary Outcomes (2)

• To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6

• Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe

Study Arms (2)

1

EXPERIMENTAL

Rosuvastatin 40mg/Ezetimibe 10mg combination therapy

Drug: Rosuvastatin; Drug: Ezetimibe

2

EXPERIMENTAL

Rosuvastatin 40 mg

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

40mg

Also known as: Crestor

1; 2

Ezetimibe DRUG

10mg

Also known as: Zetia

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
• Fasting LDL-C concentrations at Visit 1 as defined in the protocol.
• Discontinuation of all lipid lowering therapy at Visit 1.

You may not qualify if:

• History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
• Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
• Severe congestive cardiac failure (as defined by the protocol - Appendix I).
• Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Hypercholesterolemia; Coronary Disease; Atherosclerosis

Interventions

Rosuvastatin Calcium; Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azetidines; Azetines

Study Officials

• Christine Ballantyne, MD

  Centre for prevention of cardiovascular disease, Texas, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: June 1, 2004
• Study Completion: June 1, 2005
• Last Updated: March 26, 2009

Record last verified: 2009-03