Trial Outcomes & Findings for Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia (NCT NCT00330876)
NCT ID: NCT00330876
Last Updated: 2010-03-16
Results Overview
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
545 participants
Primary outcome timeframe
Baseline to 60 weeks
Results posted on
2010-03-16
Participant Flow
Participant milestones
| Measure |
Pitavastatin 2 mg QD
Pitavastatin 2 mg once daily
|
Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
|
|---|---|---|
|
Overall Study
STARTED
|
449
|
90
|
|
Overall Study
COMPLETED
|
378
|
77
|
|
Overall Study
NOT COMPLETED
|
71
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Baseline characteristics by cohort
| Measure |
Safety Population
n=539 Participants
Subjects who received at least one dose of Pitavastatin 2 or 4 mg once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
539 Participants
n=93 Participants
|
|
Age Continuous
|
70.3 years
STANDARD_DEVIATION 4.73 • n=93 Participants
|
|
Sex: Female, Male
Female
|
294 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
245 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline to 60 weeksPopulation: Subjects with measurement at Week 60
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=376 Participants
Pitavastatin 2 mg once daily
|
Pitavastatin 4 mg QD
n=77 Participants
Pitavastatin 4 mg once daily
|
|---|---|---|
|
Change From Baseline in LDL-C
|
-43.18 percent change
Standard Deviation 10.065
|
-44.26 percent change
Standard Deviation 10.764
|
SECONDARY outcome
Timeframe: Baseline to 60 weeksPopulation: Subjects with a measurement at Week 60
Percent change from baseline in total cholesterol (TC)
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=378 Participants
Pitavastatin 2 mg once daily
|
Pitavastatin 4 mg QD
n=77 Participants
Pitavastatin 4 mg once daily
|
|---|---|---|
|
Change From Baseline in Total Cholesterol
|
-28.27 percent change
Standard Deviation 8.214
|
-30.54 percent change
Standard Deviation 8.226
|
Adverse Events
Pitavastatin 2 mg QD
Serious events: 51 serious events
Other events: 286 other events
Deaths: 0 deaths
Pitavastatin 4 mg QD
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pitavastatin 2 mg QD
n=449 participants at risk
Pitavastatin 2 mg once daily
|
Pitavastatin 4 mg QD
n=90 participants at risk
Pitavastatin 4 mg once daily
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.22%
1/449
|
0.00%
0/90
|
|
Cardiac disorders
Acute mycocardial infarction
|
0.22%
1/449
|
0.00%
0/90
|
|
Cardiac disorders
Angina pectoris
|
0.45%
2/449
|
0.00%
0/90
|
|
Cardiac disorders
Aortic valve disease
|
0.22%
1/449
|
0.00%
0/90
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/449
|
1.1%
1/90
|
|
Cardiac disorders
Atrial fibrillation
|
0.22%
1/449
|
0.00%
0/90
|
|
Cardiac disorders
Atrioventricular block
|
0.22%
1/449
|
0.00%
0/90
|
|
Cardiac disorders
Cardiac arrest
|
0.22%
1/449
|
0.00%
0/90
|
|
Cardiac disorders
Cardiac failure
|
0.22%
1/449
|
0.00%
0/90
|
|
Cardiac disorders
Cporonary artery occlusion
|
0.00%
0/449
|
1.1%
1/90
|
|
Cardiac disorders
Myocardial infarction
|
0.45%
2/449
|
0.00%
0/90
|
|
Ear and labyrinth disorders
hypoacusis
|
0.22%
1/449
|
0.00%
0/90
|
|
Eye disorders
Glaucoma
|
0.22%
1/449
|
0.00%
0/90
|
|
Eye disorders
Macular hole
|
0.22%
1/449
|
0.00%
0/90
|
|
Eye disorders
Retinal detachment
|
0.00%
0/449
|
1.1%
1/90
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.22%
1/449
|
0.00%
0/90
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.22%
1/449
|
0.00%
0/90
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.22%
1/449
|
0.00%
0/90
|
|
Gastrointestinal disorders
Nausea
|
0.22%
1/449
|
0.00%
0/90
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.22%
1/449
|
0.00%
0/90
|
|
Gastrointestinal disorders
Vomiting
|
0.22%
1/449
|
0.00%
0/90
|
|
Infections and infestations
Bronchopneumonia
|
0.22%
1/449
|
0.00%
0/90
|
|
Infections and infestations
Lobar pneumonia
|
0.22%
1/449
|
0.00%
0/90
|
|
Infections and infestations
Pneumonia
|
0.22%
1/449
|
0.00%
0/90
|
|
Infections and infestations
Sialoadenitis
|
0.22%
1/449
|
0.00%
0/90
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/449
|
1.1%
1/90
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.22%
1/449
|
0.00%
0/90
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/449
|
1.1%
1/90
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.22%
1/449
|
0.00%
0/90
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.22%
1/449
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.22%
1/449
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.22%
1/449
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.89%
4/449
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.22%
1/449
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.22%
1/449
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.22%
1/449
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.22%
1/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.22%
1/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.22%
1/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.22%
1/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.45%
2/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.22%
1/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.22%
1/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.22%
1/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.22%
1/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.22%
1/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.3%
6/449
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.22%
1/449
|
0.00%
0/90
|
|
Nervous system disorders
Amnesia
|
0.22%
1/449
|
0.00%
0/90
|
|
Nervous system disorders
Cerebrovascular accident
|
0.22%
1/449
|
1.1%
1/90
|
|
Nervous system disorders
Loss of consciousness
|
0.22%
1/449
|
0.00%
0/90
|
|
Psychiatric disorders
Nervousness
|
0.22%
1/449
|
0.00%
0/90
|
|
Renal and urinary disorders
Bladder prolapse
|
0.22%
1/449
|
0.00%
0/90
|
|
Renal and urinary disorders
Urethral stricture
|
0.22%
1/449
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Daiphragmatic hernia
|
0.22%
1/449
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.22%
1/449
|
0.00%
0/90
|
|
Vascular disorders
Deep vein thrombosis
|
0.22%
1/449
|
0.00%
0/90
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/449
|
1.1%
1/90
|
Other adverse events
| Measure |
Pitavastatin 2 mg QD
n=449 participants at risk
Pitavastatin 2 mg once daily
|
Pitavastatin 4 mg QD
n=90 participants at risk
Pitavastatin 4 mg once daily
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
13.2%
71/539
|
2.1%
2/95
|
|
Infections and infestations
Urinary tract infection
|
4.8%
26/539
|
4.2%
4/95
|
|
Infections and infestations
Cystitis
|
4.8%
26/539
|
1.1%
1/95
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
44/539
|
4.2%
4/95
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
34/539
|
3.2%
3/95
|
|
Musculoskeletal and connective tissue disorders
Osteaoarthritis
|
4.5%
24/539
|
5.3%
5/95
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
26/539
|
1.1%
1/95
|
|
Vascular disorders
Hypertension
|
6.5%
35/539
|
4.2%
4/95
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60