Addition of Ezetimibe (Ezetrol®) to Ongoing Therapy With Rosuvastatin (Crestor®) in HIV Positive Patients Not Reaching Cholesterol Targets

This study has been completed.
Sponsor:
Collaborator:
Merck Frosst-Schering Pharma, G.P.
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00908011
First received: May 21, 2009
Last updated: November 30, 2015
Last verified: November 2015
Results First Received: November 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypercholesterolemia
HIV Infections
Interventions: Drug: Ezetimibe
Drug: Rosuvastatin (standard care)

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Ezetimibe

10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)

Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks

Standard Care

Increased dose of rosuvastatin to 20mg/day

Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day


Participant Flow:   Overall Study
    Ezetimibe     Standard Care  
STARTED     23     20  
COMPLETED     21     18  
NOT COMPLETED     2     2  
Withdrawal by Subject                 2                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Ezetimibe

10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)

Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks

Standard Care

Increased dose of rosuvastatin to 20mg/day

Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day

Total Total of all reporting groups

Baseline Measures
    Ezetimibe     Standard Care     Total  
Number of Participants  
[units: participants]
  23     20     43  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     23     20     43  
>=65 years     0     0     0  
Age  
[units: Years]
Mean (Standard Deviation)
  56.5  (7.4)     57.0  (9.9)     57  (8.6)  
Gender  
[units: participants]
     
Female     1     3     4  
Male     22     17     39  
Region of Enrollment  
[units: participants]
     
Canada     23     20     43  



  Outcome Measures

1.  Primary:   The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe.   [ Time Frame: 3 months from baseline ]

2.  Secondary:   Percent Change in Apolipoprotein B, Percent and Absolute Change Total Cholesterol, LDL, HDL, Triglycerides, Apolipoprotein A1, apolipoproteinB/apoliporoteinA1 Ratio and C-reactive Protein   [ Time Frame: 3 months from baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Assessment of Safety Parameters, Specifically Incidence of Complications as Measured by an Increase in AST &/or ALT ≥3-fold ULN & a CK ≥10-fold ULN   [ Time Frame: 3 months from baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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: Dr. Greg Bondy
Organization: St. Paul's Hospital/University of B.C.
phone: 604-806-8192
e-mail: gbondy@providencehealth.bc.ca



Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00908011     History of Changes
Other Study ID Numbers: H08-00287
Study First Received: May 21, 2009
Results First Received: November 30, 2015
Last Updated: November 30, 2015
Health Authority: Canada: Health Canada