Trial Outcomes & Findings for A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic (NCT NCT01462877)
NCT ID: NCT01462877
Last Updated: 2015-03-17
Results Overview
Blood tests
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
506 participants
Primary outcome timeframe
Baseline and up to 8 weeks after intervention
Results posted on
2015-03-17
Participant Flow
Dyslipidemic Chinese patients with CHD or CHD equivalent, whose TG ≥1.70 mmol/L and \<5.65mmol/L after at least 2 month statin monotherapy with standard dose were enrolled. After at least 2 month statin monotherapy with standard dose, patients having high TG were recruited and given statin-fenofibrate combination therapy for 8 weeks.
Participant milestones
| Measure |
Fenofibrate Arm
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Overall Study
STARTED
|
506
|
|
Overall Study
Safety Set
|
492
|
|
Overall Study
Full Analysis Set
|
468
|
|
Overall Study
Per-protocol Set
|
364
|
|
Overall Study
COMPLETED
|
435
|
|
Overall Study
NOT COMPLETED
|
71
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
Baseline characteristics by cohort
| Measure |
Fenofibrate Arm
n=468 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 9.91 • n=99 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
274 Participants
n=99 Participants
|
|
Systolic blood pressure
|
130.93 mmHg
STANDARD_DEVIATION 12.50 • n=99 Participants
|
|
diastolic blood pressure
|
78.54 mmHg
STANDARD_DEVIATION 8.97 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 8 weeks after interventionPopulation: Full Analysis Set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=468 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Percentage of Triglyceride (TG) Change
|
-38.12 percentage of TG change
Standard Deviation 33.92
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeks after interventionPopulation: Full analysis set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=468 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Change in Serum Total Cholesterol
|
2.75 percentage of TC change
Standard Deviation 24.75
|
SECONDARY outcome
Timeframe: Baseline up to 8 weeks after interventionPopulation: Full analysis set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=468 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Change in Serum Low-density Lipoprotein Cholesterol
|
14.91 percentage of LDL-C change
Standard Deviation 39.80
|
SECONDARY outcome
Timeframe: Baseline up to 8 weeks after interventionPopulation: Full analysis set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=468 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Change in Serum High-density Lipoprotein Cholesterol
|
17.40 percentage of HDL-C change
Standard Deviation 32.62
|
SECONDARY outcome
Timeframe: Baseline up to 8 weeks after interventionPopulation: Full analysis set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=468 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Change in Serum Non-high-density Lipoprotein Cholesterol
|
-1.30 percentage of Non-HDL-C change
Standard Deviation 28.26
|
SECONDARY outcome
Timeframe: Baseline up to 8 weeks after interventionPopulation: Full analysis set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=468 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Change in Serum Apolipoprotein A1
|
12.41 percentage of apoA1 change
Standard Deviation 28.74
|
SECONDARY outcome
Timeframe: Baseline up to 8 weeks after interventionPopulation: Full analysis set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=468 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Change in Serum Apolipoprotein B
|
2.42 percentage of apoB change
Standard Deviation 50.48
|
SECONDARY outcome
Timeframe: Baseline up to 8 weeks after interventionPopulation: Safety set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=492 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Change in Serum Alanine Aminotransferase
|
0.00 percentage of ALT change
Interval -72.92 to 1118.75
|
SECONDARY outcome
Timeframe: Baseline up to 8 weeks after interventionPopulation: Safety set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=492 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Change in Serum Aspartate Aminotransferase
|
10.91 percentage of AST change
Interval -77.73 to 676.47
|
SECONDARY outcome
Timeframe: Baseline up to 8 weeks after interventionPopulation: Safety set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=492 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Change in Serum Creatine Kinase
|
8.02 percentage of CK change
Interval -73.94 to 1429.63
|
SECONDARY outcome
Timeframe: Baseline up to 8 weeks after interventionPopulation: Safety set
Blood tests
Outcome measures
| Measure |
Fenofibrate Arm
n=492 Participants
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Change in Serum Creatinine
|
12.99 percentage of Creatinine change
Interval -63.63 to 80.43
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeks after interventionBlood tests
Outcome measures
Outcome data not reported
Adverse Events
Fenofibrate Arm
Serious events: 7 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fenofibrate Arm
n=492 participants at risk
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Hepatobiliary disorders
Hepatic enzyme increased
|
0.20%
1/492 • Number of events 1 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
|
Cardiac disorders
Angina unstable
|
0.20%
1/492 • Number of events 1 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/492 • Number of events 1 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
1/492 • Number of events 1 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
1/492 • Number of events 1 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
|
Infections and infestations
Herpes zoster
|
0.20%
1/492 • Number of events 1 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
1/492 • Number of events 1 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
Other adverse events
| Measure |
Fenofibrate Arm
n=492 participants at risk
fenofibrate: Fenofibrate Capsule 200mg qd orally
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
1.0%
5/492 • Number of events 5 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
6/492 • Number of events 6 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
6/492 • Number of events 6 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.2%
6/492 • Number of events 6 • 8 weeks + 1 month
Serious Adverse Events were collected after Informed Consent was signed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER