Trial Outcomes & Findings for Rosuvastatin in Visceral Adiposity (NCT NCT01068626)
NCT ID: NCT01068626
Last Updated: 2015-08-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
54 participants
Primary outcome timeframe
6 months
Results posted on
2015-08-24
Participant Flow
From May 2006 to July 2007 a total of 78 subjects were screened at the Sahlgrenska Hospital. Among these, 59 fulfilled all inclusion and no exclusion criteria and were randomized to treatment. During follow-up 5 patients (7 %) withdrew from the study, resulting in 54 patients who completed the study, comprising 27 patients in each study group.
Among patients that were screened 19 patients did not fulfill inclusion criteria or displayed exclusion criteria and did not enter the study.
Participant milestones
| Measure |
Rosuvastatin
|
Placebo for Rosuvastatin
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Rosuvastatin
|
Placebo for Rosuvastatin
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Rosuvastatin in Visceral Adiposity
Baseline characteristics by cohort
| Measure |
Rosuvastatin
n=30 Participants
|
Placebo for Rosuvastatin
n=29 Participants
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 18 and 65 years
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
55 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
54 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Weight
|
100 kg
STANDARD_DEVIATION 12 • n=5 Participants
|
100 kg
STANDARD_DEVIATION 13 • n=7 Participants
|
100 kg
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Height
|
1.82 m
STANDARD_DEVIATION 0.06 • n=5 Participants
|
1.80 m
STANDARD_DEVIATION 0.07 • n=7 Participants
|
1.81 m
STANDARD_DEVIATION 0.07 • n=5 Participants
|
|
Hypertension
YES
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Hypertension
NO
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Current smoker
YES
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Current smoker
NO
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Visceral adipose tissue area
|
221 cm2
STANDARD_DEVIATION 66 • n=5 Participants
|
219 cm2
STANDARD_DEVIATION 73 • n=7 Participants
|
220 cm2
STANDARD_DEVIATION 69 • n=5 Participants
|
|
Subcutaneous adipose tissue area
|
289 cm2
STANDARD_DEVIATION 69 • n=5 Participants
|
310 cm2
STANDARD_DEVIATION 101 • n=7 Participants
|
300 cm2
STANDARD_DEVIATION 86 • n=5 Participants
|
|
Visceral/subcutaneous adipose tissue area ratio
|
0.79 ratio
STANDARD_DEVIATION 0.25 • n=5 Participants
|
0.75 ratio
STANDARD_DEVIATION 0.27 • n=7 Participants
|
0.77 ratio
STANDARD_DEVIATION 0.26 • n=5 Participants
|
|
Liver density
|
52 Hounsfield units
STANDARD_DEVIATION 10 • n=5 Participants
|
49 Hounsfield units
STANDARD_DEVIATION 14 • n=7 Participants
|
50 Hounsfield units
STANDARD_DEVIATION 12 • n=5 Participants
|
|
LDL cholesterol
|
3.59 mmol/L
STANDARD_DEVIATION 0.78 • n=5 Participants
|
3.77 mmol/L
STANDARD_DEVIATION 0.79 • n=7 Participants
|
3.69 mmol/L
STANDARD_DEVIATION 0.74 • n=5 Participants
|
|
Fasting glucose
|
5.3 mmol/L
STANDARD_DEVIATION 0.5 • n=5 Participants
|
5.3 mmol/L
STANDARD_DEVIATION 0.5 • n=7 Participants
|
5.3 mmol/L
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Fasting insulin
|
12 IU
STANDARD_DEVIATION 4.8 • n=5 Participants
|
13 IU
STANDARD_DEVIATION 9.4 • n=7 Participants
|
12 IU
STANDARD_DEVIATION 8.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Per protocol
Outcome measures
| Measure |
Rosuvastatin
n=27 Participants
|
Placebo for Rosuvastatin
n=27 Participants
|
|---|---|---|
|
Change in Visceral Adipose Tissue Area Measured by Computed Tomography.
|
-1.5 cm2
Standard Deviation 27
|
2.8 cm2
Standard Deviation 26
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Rosuvastatin
n=27 Participants
|
Placebo for Rosuvastatin
n=27 Participants
|
|---|---|---|
|
Change in Subcutaneous Adipose Tissue Area
|
10 cm2
Standard Deviation 34
|
1 cm2
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Rosuvastatin
n=27 Participants
|
Placebo for Rosuvastatin
n=27 Participants
|
|---|---|---|
|
Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.
|
-0.02 ratio
Standard Deviation 0.11
|
0.01 ratio
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Rosuvastatin
n=27 Participants
|
Placebo for Rosuvastatin
n=27 Participants
|
|---|---|---|
|
Change in Hepatic Fat Infiltration Measured by CT.
|
0 Hounsfield units
Standard Deviation 5.2
|
-2 Hounsfield units
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Rosuvastatin
n=27 Participants
|
Placebo for Rosuvastatin
n=27 Participants
|
|---|---|---|
|
Change in Body Weight
|
0.2 kg
Standard Deviation 2.6
|
0.5 kg
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Rosuvastatin
n=27 Participants
|
Placebo for Rosuvastatin
n=27 Participants
|
|---|---|---|
|
Change in LDL
|
-1.4 mmol/L
Standard Deviation 0.9
|
-0.1 mmol/L
Standard Deviation 0.9
|
Adverse Events
Rosuvastatin
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo for Rosuvastatin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosuvastatin
n=30 participants at risk
|
Placebo for Rosuvastatin
n=29 participants at risk
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
6.7%
2/30 • Number of events 2
|
0.00%
0/29
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Number of events 1
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/30
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
Rosuvastatin
n=30 participants at risk
|
Placebo for Rosuvastatin
n=29 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • Number of events 3
|
17.2%
5/29 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications during 3 months prior to public release and can embargo communications regarding trial results for an additional period of 3 months from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
- Publication restrictions are in place
Restriction type: OTHER