12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe

NCT00525824 | Completed Phase 3 Results

• 1 other identifier: D356FC00003
• Study Type: interventional
• Target: 1,743
• Locations: 9 countries
• Sites: 9

Brief Summary

The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of \>20%

Conditions

Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis

Keywords

Hypercholesterolaemia; Coronary Heart Disease (CHD); Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment

  Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value\*100

  Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

Secondary Outcomes (12)

• Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment

  Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

• Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment

  Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

• Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment

  Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

• Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment

  Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

• Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment

  Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

Interventions

Rosuvastatin (Crestor) DRUG

10mg and 20 mg

Ezetimibe DRUG

10 mg

Simvastatin DRUG

40mg and 80 mg

Eligibility Criteria

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

You may qualify if:

• Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical evidence of atherosclerosis or a Framingham 10-year CHD risk score of \>20
• Patients will need to sign an informed consent before any visit procedures can be performed, including procedures for the optional genetic research and biomarker studies.
• Patients must be 18 years or older and will be asked to stop taking any current cholesterol-lowering medications. Dietary counselling will be provided which will include an overview of the Therapeutic Lifestyle Change (TLC) diet the patients will be asked to follow

You may not qualify if:

• Use of lipid lowering drugs and other prohibited concomitant medications. History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe.
• Patients considered to be unstable by their physician after the following events:
• a myocardial infarction, recent episode of unstable angina, myocardial revascularisation \[percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) surgery or another revascularisation procedure\] or a transient ischaemic attack (TIA) or stroke and patients awaiting a planned myocardial revascularisation

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Research Site

Brentwood, Tennessee, United States

Location

Research Site

Buenos Aires, Argentina

Location

Research Site

São Paulo, São Paulo, Brazil

Location

Research Site

Santiago, Chile

Location

Research Site

Brentwood, Colombia

Location

Research Site

Brentwood, Lithuania

Location

Research Site

Zwinderen, Netherlands

Location

Research Site

Lima, San Isidro Lima, Peru

Location

Research Site

Brentwood, Venezuela

Location

MeSH Terms

Conditions

Hypercholesterolemia; Coronary Disease; Atherosclerosis

Interventions

Rosuvastatin Calcium; Ezetimibe; Simvastatin

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; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

AZTrial_Results_Posting@astrazeneca.com

Study Officials

• Christie M Ballantyne, MD FACP FACC

  Centre for Cardiovascular Disease Prevention

  PRINCIPAL INVESTIGATOR

• Margareta Grind, MD PhD FFPM

  Medicine and Sciences AstraZeneca

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 5, 2007
• First Posted: September 6, 2007
• Study Start: August 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 13, 2011
• Results First Posted: October 7, 2009

Record last verified: 2011-05

Locations

PE (1); CO (1); US (1); CL (1); LI (1); NL (1); AR (1); BR (1); VE (1)