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Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease

This study has been completed.
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00329160
First received: May 22, 2006
Last updated: August 29, 2011
Last verified: August 2011
History of Changes
Results First Received: March 17, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypercholesteremia
Interventions: Drug: Rosuvastatin
Drug: HMG CoA inhibitor

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Observation Period :Prior to study-related activities, all subjects will sign an informed consent form. IVUS and CAG is performed prior Treatment Treatment Period: Eligible patients started treatment; rosuvastatin 2.5 mg once daily; those whose LDL-C remained >80 mg/dl after 4 wks of treatment, the dose can be titrated to a maximum of 20 mg/day

Reporting Groups
  Description
Rosuvastatin rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.

Participant Flow:   Overall Study
    Rosuvastatin  
STARTED     214  
Observation Period     214  
Treatment Period     214  
COMPLETED     126  
NOT COMPLETED     88  
Adverse Event                 27  
Withdrawal by Subject                 13  
Protocol Violation                 2  
Did not Receive Study Drug                 1  
Incomplete IVUS                 45  



  Baseline Characteristics
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Reporting Groups
  Description
Rosuvastatin rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.

Baseline Measures
    Rosuvastatin  
Number of Participants  
[units: participants]
 		  126  
Age  
[units: years]
Mean ± Standard Deviation 		 
Years     62.6  ± 7.7  
Gender [1]
[units: Participants]
 		 
Female     30  
Male     96  
[1] 1 participant did not receive drug and is not captured in these figures



  Outcome Measures
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1.  Primary:   Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)   [ Time Frame: Baseline and 76 weeks ]
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2.  Secondary:   Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion   [ Time Frame: Baseline - 76Weeks ]
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3.  Secondary:   Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）   [ Time Frame: Baseline - 76Weeks ]
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4.  Secondary:   Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points   [ Time Frame: Baseline - 76Weeks ]
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
Because there was no placebo arm the net effect of rosuvastatin was not clarified. This study examined only single measurable plaques, which might not represent pan-coronary nature of plaque.  


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


No publications provided by AstraZeneca

Publications automatically indexed to this study:


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00329160     History of Changes
Other Study ID Numbers: D3565L00002, 0407E1841
Study First Received: May 22, 2006
Results First Received: March 17, 2011
Last Updated: August 29, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare