Trial Outcomes & Findings for Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia (NCT NCT00325780)
NCT ID: NCT00325780
Last Updated: 2010-02-02
Results Overview
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1355 participants
Primary outcome timeframe
Baseline to 52 Weeks
Results posted on
2010-02-02
Participant Flow
Participant milestones
| Measure |
Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
|
|---|---|
|
Overall Study
STARTED
|
1355
|
|
Overall Study
Safety Population
|
1353
|
|
Overall Study
COMPLETED
|
1200
|
|
Overall Study
NOT COMPLETED
|
155
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Baseline characteristics by cohort
| Measure |
Pitavastatin 4 mg QD
n=1353 Participants
Pitavastatin 4 mg once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
941 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
412 Participants
n=5 Participants
|
|
Age Continuous
|
58.6 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
778 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
575 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 52 WeeksPopulation: Patients who had an observation at Week 52
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)
Outcome measures
| Measure |
Pitavastatin 4 mg QD
n=1202 Participants
Pitavastatin 4 mg once daily
|
|---|---|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
|
-42.89 percent change
Standard Deviation 16.001
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: Patients who had an observation at Week 52
Mean percent change from baseline in total cholesterol
Outcome measures
| Measure |
Pitavastatin 4 mg QD
n=1203 Participants
Pitavastatin 4 mg once daily
|
|---|---|
|
Change From Baseline in Total Cholesterol
|
-29.59 percent change
Standard Deviation 12.549
|
Adverse Events
Pitavastatin 4 mg QD
Serious events: 49 serious events
Other events: 293 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pitavastatin 4 mg QD
n=1353 participants at risk
Pitavastatin 4 mg once daily
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.07%
1/1353
|
|
Cardiac disorders
Angina pectoris
|
0.07%
1/1353
|
|
Cardiac disorders
Angina unstable
|
0.30%
4/1353
|
|
Cardiac disorders
Atrial fibrillation
|
0.07%
1/1353
|
|
Cardiac disorders
Coronary artery disease
|
0.07%
1/1353
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
4/1353
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.07%
1/1353
|
|
Cardiac disorders
Ventricular tachycardia
|
0.07%
1/1353
|
|
Eye disorders
Retinal detachment
|
0.07%
1/1353
|
|
Gastrointestinal disorders
Diverticulum
|
0.07%
1/1353
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.07%
1/1353
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.07%
1/1353
|
|
Gastrointestinal disorders
Gastric polyps
|
0.07%
1/1353
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.07%
1/1353
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.07%
1/1353
|
|
Gastrointestinal disorders
Peritonitis
|
0.07%
1/1353
|
|
General disorders
Cardiac death
|
0.07%
1/1353
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.07%
1/1353
|
|
Infections and infestations
Anal abscess
|
0.07%
1/1353
|
|
Infections and infestations
Appendicitis
|
0.07%
1/1353
|
|
Infections and infestations
Chronic tonsillitis
|
0.07%
1/1353
|
|
Infections and infestations
Erysipelas
|
0.07%
1/1353
|
|
Infections and infestations
Osteomyelitis acute
|
0.07%
1/1353
|
|
Infections and infestations
Pneumonia bacterial
|
0.07%
1/1353
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.07%
1/1353
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.07%
1/1353
|
|
Musculoskeletal and connective tissue disorders
Fascitis
|
0.07%
1/1353
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.07%
1/1353
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.07%
1/1353
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.07%
1/1353
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.07%
1/1353
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.07%
1/1353
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.07%
1/1353
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.07%
1/1353
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.07%
1/1353
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.07%
1/1353
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.07%
1/1353
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.07%
1/1353
|
|
Nervous system disorders
Cranial neuropathy
|
0.07%
1/1353
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.07%
1/1353
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.07%
1/1353
|
|
Nervous system disorders
Ischaemic stroke
|
0.15%
2/1353
|
|
Nervous system disorders
Vascular encephalopathy
|
0.07%
1/1353
|
|
Psychiatric disorders
Insomnia
|
0.07%
1/1353
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.07%
1/1353
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.07%
1/1353
|
|
Vascular disorders
Hypertension
|
0.15%
2/1353
|
|
Vascular disorders
Thrombophlebitis
|
0.07%
1/1353
|
Other adverse events
| Measure |
Pitavastatin 4 mg QD
n=1353 participants at risk
Pitavastatin 4 mg once daily
|
|---|---|
|
Infections and infestations
Influenza
|
3.0%
41/1353
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
73/1353
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
46/1353
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.1%
55/1353
|
|
Investigations
Blood creatine phosphokinase increased
|
5.8%
78/1353
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60