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

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ClinicalTrials.gov Identifier: NCT00908011
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
Merck Frosst-Schering Pharma, G.P.
Information provided by (Responsible Party):
University of British Columbia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypercholesterolemia
HIV Infections
Interventions Drug: Ezetimibe
Drug: Rosuvastatin (standard care)
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ezetimibe Standard Care
Hide Arm/Group Description

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

Increased dose of rosuvastatin to 20mg/day

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

Period Title: Overall Study
Started 23 20
Completed 21 18
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             2             2
Arm/Group Title Ezetimibe Standard Care Total
Hide Arm/Group Description

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

Increased dose of rosuvastatin to 20mg/day

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

Total of all reporting groups
Overall Number of Baseline Participants 23 20 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 20 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
20
 100.0%
43
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 20 participants 43 participants
56.5  (7.4) 57.0  (9.9) 57  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 20 participants 43 participants
Female
1
   4.3%
3
  15.0%
4
   9.3%
Male
22
  95.7%
17
  85.0%
39
  90.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 23 participants 20 participants 43 participants
23 20 43
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 3 months from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ezetimibe Standard Care
Hide Arm/Group Description:

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

Increased dose of rosuvastatin to 20mg/day

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

Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.88  (0.22) 0.89  (0.25)
2.Secondary Outcome
Title Percent Change in Apolipoprotein B, Percent and Absolute Change Total Cholesterol, LDL, HDL, Triglycerides, Apolipoprotein A1, apolipoproteinB/apoliporoteinA1 Ratio and C-reactive Protein
Hide Description [Not Specified]
Time Frame 3 months from baseline
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 3 months from baseline
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ezetimibe Standard Care
Hide Arm/Group Description

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

Increased dose of rosuvastatin to 20mg/day

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

All-Cause Mortality
Ezetimibe Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Ezetimibe Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ezetimibe Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/20 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Greg Bondy
Organization: St. Paul's Hospital/University of B.C.
Phone: 604-806-8192
EMail: gbondy@providencehealth.bc.ca
Layout table for additonal information
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00908011    
Other Study ID Numbers: H08-00287
First Submitted: May 21, 2009
First Posted: May 25, 2009
Results First Submitted: November 30, 2015
Results First Posted: January 1, 2016
Last Update Posted: January 1, 2016