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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00525824
First received: September 5, 2007
Last updated: May 11, 2011
Last verified: May 2011
Results First Received: September 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypercholesterolemia
Coronary Heart Disease
Atherosclerosis
Interventions: Drug: Rosuvastatin (Crestor)
Drug: Ezetimibe
Drug: Simvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eight hundred thirty-three patients (with hypercholesterolaemia and CHD or CHD risk equivalent, atherosclerosis or a 10-year CHD risk of >20%) were randomized into the study, from 111 sites located in the United States (56), Peru (13), Netherlands (12), Colombia (8), Argentina (8), Brazil (6), Chile (4) and Lithuania (4).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients underwent screening procedures (Week –6; Visit 1), and entered a 6-week dietary lead-in period. Those who fulfilled all eligibility criteria (Week –6; Visit 1) and had qualifying lipid values at Visit 2 were randomly allocated (1:1:1:1) to 1 of 4 treatments for a period of 12 weeks.

Reporting Groups
  Description
R10 to R10 + E10 Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
R20 to R20 + E10 Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
S40 to S40 + E10 Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
S80 to S80 + E10 Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg

Participant Flow:   Overall Study
    R10 to R10 + E10     R20 to R20 + E10     S40 to S40 + E10     S80 to S80 + E10  
STARTED     214 [1]   214 [1]   202 [1]   203 [1]
COMPLETED     195     186     183     188  
NOT COMPLETED     19     28     19     15  
Adverse Event                 7                 11                 6                 7  
Withdrawal by Subject                 5                 9                 3                 4  
Lost to Follow-up                 4                 2                 4                 0  
Incorrect enrolment/mis-randomisation                 1                 2                 1                 2  
Severe non-compliance                 0                 1                 1                 1  
Safety reasons                 1                 0                 1                 0  
Other                 1                 3                 3                 1  
[1] Randomized population



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
R10 to R10 + E10 Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
R20 to R20 + E10 Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
S40 to S40 + E10 Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
S80 to S80 + E10 Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
Total Total of all reporting groups

Baseline Measures
    R10 to R10 + E10     R20 to R20 + E10     S40 to S40 + E10     S80 to S80 + E10     Total  
Number of Participants  
[units: participants]
  214     214     202     203     833  
Age  
[units: years]
Mean ± Standard Deviation
  62.2  ± 10.14     61.8  ± 9.93     61.9  ± 9.37     62.1  ± 9.17     62.0  ± 9.66  
Gender  
[units: Participants]
         
Female     91.0000     97.0000     97.0000     90.0000     375.0  
Male     123.0000     117.0000     105.0000     113.0000     458.0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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) ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   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) ]

7.  Secondary:   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) ]

8.  Secondary:   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) ]

9.  Secondary:   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) ]

10.  Secondary:   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) ]

11.  Secondary:   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) ]

12.  Secondary:   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) ]

13.  Secondary:   Percent Change in LDL-C After 6 Weeks Monotherapy   [ Time Frame: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: AZTrial_Results_Posting@astrazeneca.com


No publications provided


Responsible Party: Michael Cressman - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00525824     History of Changes
Other Study ID Numbers: D356FC00003
Study First Received: September 5, 2007
Results First Received: September 3, 2009
Last Updated: May 11, 2011
Health Authority: United States: Food and Drug Administration