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A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

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ClinicalTrials.gov Identifier: NCT01301066
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Collaborators:
Kowa Pharmaceuticals America, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dyslipidemia
Interventions Drug: Pitavastatin
Drug: Pravastatin
Enrollment 252
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pitavastatin 4 mg QD Pravastatin 40 mg QD
Hide Arm/Group Description Pitavastatin: Pitavastatin 4 mg QD Pravastatin: Pravastatin 40 mg QD
Period Title: Overall Study
Started 126 126
Completed 99 91
Not Completed 27 35
Reason Not Completed
Lost to Follow-up             5             11
Protocol Violation             8             7
Withdrawal by Subject             4             9
Adverse Event             6             6
Sponsor Decision             2             1
Physician Decision             0             1
Other             2             0
Arm/Group Title Pitavastatin 4 mg QD Pravastatin 40 mg QD Total
Hide Arm/Group Description Pitavastatin: Pitavastatin 4 mg QD Pravastatin: Pravastatin 40 mg QD Total of all reporting groups
Overall Number of Baseline Participants 126 126 252
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 126 participants 252 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
126
 100.0%
126
 100.0%
252
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 126 participants 252 participants
Female
20
  15.9%
15
  11.9%
35
  13.9%
Male
106
  84.1%
111
  88.1%
217
  86.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 126 participants 126 participants 252 participants
126 126 252
1.Primary Outcome
Title Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
Hide Description [Not Specified]
Time Frame 12 weeks minus baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
modified Intent To Treat (mITT) population included all randomized subjects who received at least 1 dose of study drug and had at least 1 on-treatment lipid assessment
Arm/Group Title Pitavastatin 4 mg QD Pravastatin 40 mg QD
Hide Arm/Group Description:
Pitavastatin: Pitavastatin 4 mg QD
Pravastatin: Pravastatin 40 mg QD
Overall Number of Participants Analyzed 121 126
Mean (Standard Deviation)
Unit of Measure: mg/dL
155.1  (25.93) 154.6  (23.91)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pitavastatin 4 mg QD Pravastatin 40 mg QD
Hide Arm/Group Description Pitavastatin: Pitavastatin 4 mg QD Pravastatin: Pravastatin 40 mg QD
All-Cause Mortality
Pitavastatin 4 mg QD Pravastatin 40 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pitavastatin 4 mg QD Pravastatin 40 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/126 (5.56%)      3/126 (2.38%)    
Cardiac disorders     
Arteriosclerosis coronary artery  0/126 (0.00%)  0 1/126 (0.79%)  1
Atrial septal defect  1/126 (0.79%)  1 0/126 (0.00%)  0
Chest pain  1/126 (0.79%)  1 0/126 (0.00%)  0
Myocardial infarction  0/126 (0.00%)  0 1/126 (0.79%)  1
Gastrointestinal disorders     
Diverticulitis  1/126 (0.79%)  1 0/126 (0.00%)  0
Enterovesical fistula  1/126 (0.79%)  1 0/126 (0.00%)  0
Gastroenteritis  1/126 (0.79%)  1 0/126 (0.00%)  0
Gastroenteritis viral  1/126 (0.79%)  1 0/126 (0.00%)  0
Infections and infestations     
Herpes dermatitis  1/126 (0.79%)  1 0/126 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Multiple fractures  1/126 (0.79%)  1 0/126 (0.00%)  0
Muscle haemorrhage  0/126 (0.00%)  0 1/126 (0.79%)  1
Nervous system disorders     
Cerebrovascular accident  0/126 (0.00%)  0 1/126 (0.79%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1/126 (0.79%)  1 0/126 (0.00%)  0
Respiratory failure  1/126 (0.79%)  1 0/126 (0.00%)  0
Vascular disorders     
Transient ischaemic attack  1/126 (0.79%)  1 0/126 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.6%
Pitavastatin 4 mg QD Pravastatin 40 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/126 (7.94%)      5/126 (3.97%)    
Blood and lymphatic system disorders     
Blood CK increased  2/126 (1.59%)  0/126 (0.00%) 
Gastrointestinal disorders     
Upper abdominal pain  2/126 (1.59%)  0/126 (0.00%) 
Diarrhoea  2/126 (1.59%)  0/126 (0.00%) 
Nausea  1/126 (0.79%)  3/126 (2.38%) 
General disorders     
Fatigue  2/126 (1.59%)  1/126 (0.79%) 
Headache  2/126 (1.59%)  1/126 (0.79%) 
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.
Sponsor shall have the right to the first publication of the results of the Study. PI may publish, however PI must submit publication to sponsor for review at least 60 days prior to proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary.
Results Point of Contact
Name/Title: Roger Morgan, MD, FACS
Organization: Kowa Research Institute, Inc.
Phone: 919-433-1600
Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01301066     History of Changes
Other Study ID Numbers: NK-104-4.05US
First Submitted: February 18, 2011
First Posted: February 23, 2011
Results First Submitted: February 10, 2014
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014