Trial Outcomes & Findings for Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia (NCT NCT00344370)
NCT ID: NCT00344370
Last Updated: 2010-02-02
Results Overview
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
214 participants
Primary outcome timeframe
44 weeks
Results posted on
2010-02-02
Participant Flow
Participant milestones
| Measure |
Pitavastatin 4 mg
Pitavastatin 4 mg once daily
|
Atorvastatin 40 mg
Atorvastatin 40 mg once daily
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
71
|
|
Overall Study
COMPLETED
|
128
|
68
|
|
Overall Study
NOT COMPLETED
|
15
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Baseline characteristics by cohort
| Measure |
Pitavastatin 4 mg
n=143 Participants
Pitavastatin 4 mg once daily
|
Atorvastatin 40 mg
n=71 Participants
Atorvastatin 40 mg once daily
|
Total
n=214 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
|
95 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age Continuous
|
59.3 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 9.21 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 44 weeksPopulation: The efficacy population is defined as all patients who received at least one dose of study drug and who had at least one on-treatment lipid assessment
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.
Outcome measures
| Measure |
Pitavastatin 4 mg
n=141 Participants
Pitavastatin 4 mg once daily
|
Atorvastatin 40 mg
n=71 Participants
Atorvastatin 40 mg once daily
|
|---|---|---|
|
NCEP LDL-C Target Attainment
|
110 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Basseline to 44 weeksPercent change from baseline in LDL-C at 44 weeks
Outcome measures
| Measure |
Pitavastatin 4 mg
n=141 Participants
Pitavastatin 4 mg once daily
|
Atorvastatin 40 mg
n=71 Participants
Atorvastatin 40 mg once daily
|
|---|---|---|
|
Percent Change From Baseline in LDL-C
|
-40.98 percent change
Standard Deviation 19.053
|
-41.43 percent change
Standard Deviation 21.159
|
Adverse Events
Pitavastatin 4 mg
Serious events: 8 serious events
Other events: 22 other events
Deaths: 0 deaths
Atorvastatin 40 mg
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pitavastatin 4 mg
n=143 participants at risk
Pitavastatin 4 mg once daily
|
Atorvastatin 40 mg
n=71 participants at risk
Atorvastatin 40 mg once daily
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.70%
1/143
|
1.4%
1/71
|
|
Cardiac disorders
Angina pectoris
|
0.70%
1/143
|
0.00%
0/71
|
|
Cardiac disorders
Cardiomyopathy
|
0.70%
1/143
|
0.00%
0/71
|
|
Cardiac disorders
Myocardial infarction
|
0.70%
1/143
|
0.00%
0/71
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/143
|
1.4%
1/71
|
|
Gastrointestinal disorders
Food poisoning
|
0.70%
1/143
|
0.00%
0/71
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.70%
1/143
|
0.00%
0/71
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.70%
1/143
|
0.00%
0/71
|
|
Infections and infestations
Abdominal wall abscess
|
0.70%
1/143
|
0.00%
0/71
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/143
|
1.4%
1/71
|
|
Infections and infestations
Urosepsis
|
0.00%
0/143
|
1.4%
1/71
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.70%
1/143
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.70%
1/143
|
0.00%
0/71
|
|
Investigations
Transaminases increased
|
0.70%
1/143
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/143
|
1.4%
1/71
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/143
|
1.4%
1/71
|
|
Nervous system disorders
Ischaemic stroke
|
0.70%
1/143
|
0.00%
0/71
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.70%
1/143
|
0.00%
0/71
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.70%
1/143
|
0.00%
0/71
|
Other adverse events
| Measure |
Pitavastatin 4 mg
n=143 participants at risk
Pitavastatin 4 mg once daily
|
Atorvastatin 40 mg
n=71 participants at risk
Atorvastatin 40 mg once daily
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia/myalgia intercostal
|
4.2%
6/143
|
7.0%
5/71
|
|
Musculoskeletal and connective tissue disorders
Naspopharyngitis
|
7.0%
10/143
|
2.8%
2/71
|
|
Vascular disorders
Arteriosclerosis
|
2.8%
4/143
|
5.6%
4/71
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.4%
2/143
|
5.6%
4/71
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60