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

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

This study has been completed.

Study NCT00525824 Information provided by AstraZeneca

First Received on September 5, 2007. Last Updated on May 11, 2011 History of Changes

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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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

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

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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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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