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

May 11, 2011 updated by: AstraZeneca

A 12-week Open-label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to Compare the Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe and Simvastatin in Patients With Hypercholesterolaemia and CHD

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%

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1743

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • Research Site
  • Chile
      • Santiago, Chile
        • Research Site
  • Colombia
      • Brentwood, Colombia
        • Research Site
  • Lithuania
      • Brentwood, Lithuania
        • Research Site
  • Netherlands
      • Zwinderen, Netherlands
        • Research Site
  • Peru
    • San Isidro Lima
      • Lima, San Isidro Lima, Peru
        • Research Site
  • United States
    • Tennessee
      • Brentwood, Tennessee, United States
        • Research Site
  • Venezuela
      • Brentwood, Venezuela
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100
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
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in TC/HDL-C After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment
Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in LDL-C After 6 Weeks Monotherapy
Time Frame: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)
Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100
Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christie M Ballantyne, MD FACP FACC, Centre for Cardiovascular Disease Prevention
  • Study Chair: Margareta Grind, MD PhD FFPM, Medicine and Sciences AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D356FC00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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