Trial Outcomes & Findings for Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus (NCT NCT00412841)
NCT ID: NCT00412841
Last Updated: 2018-11-23
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
9 months
Results posted on
2018-11-23
Participant Flow
Participant milestones
| Measure |
Atorvastatin
40 mg
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=22 Participants
Atorvastatin 40mg
|
Placebo
n=21 Participants
|
Total
n=43 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
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35 years
n=5 Participants
|
35 years
n=7 Participants
|
35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
Atorvastatin
n=22 Participants
Atorvastatin 40mg
|
Placebo
n=21 Participants
|
|---|---|---|
|
Number of Participants With AVN After 9 Months
|
12 participants
|
16 participants
|
SECONDARY outcome
Timeframe: 4 monthsOutcome measures
| Measure |
Atorvastatin
n=22 Participants
Atorvastatin 40mg
|
Placebo
n=21 Participants
|
|---|---|---|
|
Number of Participants With AVN After 4 Months
|
14 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Study Terminated. No data available for analysis. Secondary Outcome measure was not included in analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 yearsPopulation: Study Terminated. No data available for analysis. Secondary Outcome measure was not included in analysis.
Outcome measures
Outcome data not reported
Adverse Events
Atorvastatin
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin
n=22 participants at risk
Atorvastatin 40mg
|
Placebo
n=21 participants at risk
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Fever of unknown origin
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Fever, dyspnea
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Elevated CPK
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Cardiac disorders
Asystolic arrest
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
candida esophagitis
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
elevated LFTS
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
herpes zoster
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
pustular psoriasis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
palpitations
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Renal and urinary disorders
UTI
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Reproductive system and breast disorders
vaginal candidiasis
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
lung cancer
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
tooth abscess
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place