Mercury II - Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

An Open Label, Randomized, Multi-Center, Phase IIIB, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654407
• Other study ID #: 4522IL/0068
• Secondary ID: D3560C00068
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: March 13, 2009
• Start date: November 2001
• Est. completion date: September 2004

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyCanada: Health CanadaMexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4875
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Discontinuation of all cholesterol lowing drugs, including dietary supplements.

• Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.

Exclusion Criteria:

• The use of lipid lowering drugs or dietary supplements after Visit 1.

• Active arterial disease eg Unstable angina, or recent arterial surgery

• Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

• Abnormal laboratory parameters as defined in the protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

• Atorvastatin

• Simvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.		16 weeks
Secondary	Percentage change in other cholesterol & triglyceride measures		16 weeks
Secondary	Safety evaluation		8 & 16 weeks
Secondary	To compare the efficacy of rosuvastatin with atorvastatin and simvastatin