Trial Outcomes & Findings for Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance (NCT NCT00639223)
NCT ID: NCT00639223
Last Updated: 2010-01-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
12 weeks
Results posted on
2010-01-18
Participant Flow
Participant milestones
| Measure |
Pravastatin
|
Red Yeast Rice
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Pravastatin
|
Red Yeast Rice
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
Baseline characteristics by cohort
| Measure |
Pravastatin
n=22 Participants
|
Red Yeast Rice
n=21 Participants
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Age Continuous
|
62.9 years
STANDARD_DEVIATION 6.6 • n=93 Participants
|
62.4 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
62.7 years
STANDARD_DEVIATION 7.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=93 Participants
|
21 participants
n=4 Participants
|
43 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Pravastatin
n=22 Participants
|
Red Yeast Rice
n=21 Participants
|
|---|---|---|
|
Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Pravastatin
n=22 Participants
|
Red Yeast Rice
n=21 Participants
|
|---|---|---|
|
Change in LDL-Cholesterol Measured at the Beginning and End of the Study
|
-27.0 Percentage Change
Standard Deviation 15.4
|
-30.2 Percentage Change
Standard Deviation 10.5
|
Adverse Events
Pravastatin
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Red Yeast Rice
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pravastatin
n=22 participants at risk
|
Red Yeast Rice
n=21 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal bloating or gas
|
0.00%
0/22
|
9.5%
2/21 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/22
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • Number of events 2
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
27.3%
6/22 • Number of events 6
|
23.8%
5/21 • Number of events 5
|
|
Nervous system disorders
Headache
|
9.1%
2/22 • Number of events 2
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/22
|
9.5%
2/21 • Number of events 2
|
|
General disorders
Fatigue
|
13.6%
3/22 • Number of events 3
|
0.00%
0/21
|
Additional Information
Steven Halbert MD, MSCE
U. of Pennsylvania Health System
Phone: 215 510 2221
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place