Trial Outcomes & Findings for A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects (NCT NCT01301066)
NCT ID: NCT01301066
Last Updated: 2014-04-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
252 participants
Primary outcome timeframe
12 weeks minus baseline
Results posted on
2014-04-29
Participant Flow
Participant milestones
| Measure |
Pitavastatin 4 mg QD
Pitavastatin: Pitavastatin 4 mg QD
|
Pravastatin 40 mg QD
Pravastatin: Pravastatin 40 mg QD
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
126
|
|
Overall Study
COMPLETED
|
99
|
91
|
|
Overall Study
NOT COMPLETED
|
27
|
35
|
Reasons for withdrawal
| Measure |
Pitavastatin 4 mg QD
Pitavastatin: Pitavastatin 4 mg QD
|
Pravastatin 40 mg QD
Pravastatin: Pravastatin 40 mg QD
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
|
Overall Study
Protocol Violation
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
9
|
|
Overall Study
Adverse Event
|
6
|
6
|
|
Overall Study
Sponsor Decision
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
Baseline characteristics by cohort
| Measure |
Pitavastatin 4 mg QD
n=126 Participants
Pitavastatin: Pitavastatin 4 mg QD
|
Pravastatin 40 mg QD
n=126 Participants
Pravastatin: Pravastatin 40 mg QD
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
126 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=5 Participants
|
126 participants
n=7 Participants
|
252 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks minus baselinePopulation: 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
Outcome measures
| Measure |
Pitavastatin 4 mg QD
n=121 Participants
Pitavastatin: Pitavastatin 4 mg QD
|
Pravastatin 40 mg QD
n=126 Participants
Pravastatin: Pravastatin 40 mg QD
|
|---|---|---|
|
Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
|
155.1 mg/dL
Standard Deviation 25.93
|
154.6 mg/dL
Standard Deviation 23.91
|
Adverse Events
Pitavastatin 4 mg QD
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Pravastatin 40 mg QD
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pitavastatin 4 mg QD
n=126 participants at risk
Pitavastatin: Pitavastatin 4 mg QD
|
Pravastatin 40 mg QD
n=126 participants at risk
Pravastatin: Pravastatin 40 mg QD
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/126
|
0.79%
1/126 • Number of events 1
|
|
Cardiac disorders
Atrial septal defect
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/126
|
0.79%
1/126 • Number of events 1
|
|
Cardiac disorders
Chest pain
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
|
Gastrointestinal disorders
Diverticulitis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
|
Infections and infestations
Herpes dermatitis
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
|
Musculoskeletal and connective tissue disorders
Multiple fractures
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/126
|
0.79%
1/126 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/126
|
0.79%
1/126 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
|
Vascular disorders
Transient ischaemic attack
|
0.79%
1/126 • Number of events 1
|
0.00%
0/126
|
Other adverse events
| Measure |
Pitavastatin 4 mg QD
n=126 participants at risk
Pitavastatin: Pitavastatin 4 mg QD
|
Pravastatin 40 mg QD
n=126 participants at risk
Pravastatin: Pravastatin 40 mg QD
|
|---|---|---|
|
General disorders
Fatigue
|
1.6%
2/126
|
0.79%
1/126
|
|
General disorders
Headache
|
1.6%
2/126
|
0.79%
1/126
|
|
Gastrointestinal disorders
Upper abdominal pain
|
1.6%
2/126
|
0.00%
0/126
|
|
Blood and lymphatic system disorders
Blood CK increased
|
1.6%
2/126
|
0.00%
0/126
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
2/126
|
0.00%
0/126
|
|
Gastrointestinal disorders
Nausea
|
0.79%
1/126
|
2.4%
3/126
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER