Trial Outcomes & Findings for Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia (NCT NCT01710007)
NCT ID: NCT01710007
Last Updated: 2023-07-17
Results Overview
The study aimed to test that the efficacy of 1PC002 group was non-inferior to Atorvastatin group in percent change from baseline of LDL-C level at Week 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
202 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-07-17
Participant Flow
Participant milestones
| Measure |
1PC002
2 mg 1PC002 once daily for 12 weeks.
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
Lipitor
10 mg atorvastatin once daily for 12 weeks.
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
99
|
|
Overall Study
COMPLETED
|
87
|
81
|
|
Overall Study
NOT COMPLETED
|
16
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
1PC002
n=103 Participants
2 mg 1PC002 once daily for 12 weeks.
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
Lipitor
n=99 Participants
10 mg atorvastatin once daily for 12 weeks.
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
Total
n=202 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
|
87 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
55.36 years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
57.90 years
STANDARD_DEVIATION 8.80 • n=7 Participants
|
56.60 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
103. participants
n=5 Participants
|
99 participants
n=7 Participants
|
202 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe study aimed to test that the efficacy of 1PC002 group was non-inferior to Atorvastatin group in percent change from baseline of LDL-C level at Week 12.
Outcome measures
| Measure |
Lipitor
n=94 Participants
10 mg atorvastatin once daily for 12 weeks.
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
1PC002
n=100 Participants
2 mg 1PC002 once daily for 12 weeks.
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
|---|---|---|
|
The Percentage Change From Baseline in LDL-C Level at Week 12.
|
-42.89 Percent change from baseline
Standard Deviation 12.80
|
-37.43 Percent change from baseline
Standard Deviation 17.97
|
SECONDARY outcome
Timeframe: week 4Population: ITT population had been analysis
Percent change from baseline in LDL-C level at Week 4
Outcome measures
| Measure |
Lipitor
n=96 Participants
10 mg atorvastatin once daily for 12 weeks.
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
1PC002
n=90 Participants
2 mg 1PC002 once daily for 12 weeks.
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
|---|---|---|
|
LDL-C
|
-39.01 Percent change from baseline
Standard Deviation 13.04
|
-40.07 Percent change from baseline
Standard Deviation 12.18
|
SECONDARY outcome
Timeframe: week 4Population: ITT
Percent change from baseline in HDL-C level at Week 4
Outcome measures
| Measure |
Lipitor
n=96 Participants
10 mg atorvastatin once daily for 12 weeks.
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
1PC002
n=90 Participants
2 mg 1PC002 once daily for 12 weeks.
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
|---|---|---|
|
HDL-C
|
0.06 Percent change from baseline
Standard Deviation 10.49
|
-1.64 Percent change from baseline
Standard Deviation 11.01
|
SECONDARY outcome
Timeframe: week 4Population: ITT
Percent change from baseline in TG level at Week 4
Outcome measures
| Measure |
Lipitor
n=96 Participants
10 mg atorvastatin once daily for 12 weeks.
Lipitor: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
1PC002
n=90 Participants
2 mg 1PC002 once daily for 12 weeks.
1PC002: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
|
|---|---|---|
|
Triglyceride
|
-18.75 Percent change from baseline
Standard Deviation 26.9
|
-19.5 Percent change from baseline
Standard Deviation 25.5
|
Adverse Events
1PC002
Serious events: 3 serious events
Other events: 58 other events
Deaths: 0 deaths
Lipitor
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1PC002
n=103 participants at risk
To summary the total adverse event of 1PC002.
|
Lipitor
n=99 participants at risk
To summary the total adverse event of Lipitor.
|
|---|---|---|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Infections and infestations
Cellulitis,right hand
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Cardiac disorders
Rheumatic heart disease with Moderate Calcified Mitral stenosis
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Infections and infestations
Urinary tract infections
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
Other adverse events
| Measure |
1PC002
n=103 participants at risk
To summary the total adverse event of 1PC002.
|
Lipitor
n=99 participants at risk
To summary the total adverse event of Lipitor.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Cardiac disorders
Arrhythmia
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Cardiac disorders
Mitral valve stenosis
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Cardiac disorders
Palpitations
|
1.9%
2/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Congenital, familial and genetic disorders
Acute pulmonary oedema
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.97%
1/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Ear and labyrinth disorders
Lacrimation decreased
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/103 • 12-16 weeks
|
2.0%
2/99 • 12-16 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.97%
1/103 • 12-16 weeks
|
2.0%
2/99 • 12-16 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
General disorders
Asthenia
|
0.97%
1/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
General disorders
Fatigue
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
General disorders
Malaise
|
0.97%
1/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
General disorders
Oedema peripheral
|
2.9%
3/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Hepatobiliary disorders
Hepatitis
|
1.9%
2/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.97%
1/103 • 12-16 weeks
|
2.0%
2/99 • 12-16 weeks
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/103 • 12-16 weeks
|
2.0%
2/99 • 12-16 weeks
|
|
Infections and infestations
Bronchitis
|
0.97%
1/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Infections and infestations
Cellulitis
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Infections and infestations
Cystitis
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Infections and infestations
Hordeolum
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Injury, poisoning and procedural complications
Pneumonia
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
11/103 • 12-16 weeks
|
9.1%
9/99 • 12-16 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
2/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Investigations
Blood bilirubin increased
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Investigations
Blood creatine phosphokinase
|
8.7%
9/103 • 12-16 weeks
|
6.1%
6/99 • 12-16 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Investigations
Blood urea increased
|
0.97%
1/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Investigations
C-reactive protein abnormal
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Investigations
C-reactive protein increased
|
0.00%
0/103 • 12-16 weeks
|
2.0%
2/99 • 12-16 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/103 • 12-16 weeks
|
2.0%
2/99 • 12-16 weeks
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Investigations
Hepatic enzyme increased
|
2.9%
3/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Investigations
Hypotension
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Investigations
Liver function test abnormal
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.97%
1/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/103 • 12-16 weeks
|
2.0%
2/99 • 12-16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
4/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.97%
1/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.9%
2/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.97%
1/103 • 12-16 weeks
|
6.1%
6/99 • 12-16 weeks
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Nervous system disorders
Dizziness
|
3.9%
4/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Nervous system disorders
Dizziness postural
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Nervous system disorders
Headache
|
2.9%
3/103 • 12-16 weeks
|
2.0%
2/99 • 12-16 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Psychiatric disorders
Insomnia
|
0.97%
1/103 • 12-16 weeks
|
4.0%
4/99 • 12-16 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Renal and urinary disorders
Microalbuminuria
|
0.97%
1/103 • 12-16 weeks
|
3.0%
3/99 • 12-16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.97%
1/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
2/103 • 12-16 weeks
|
3.0%
3/99 • 12-16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
2/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/103 • 12-16 weeks
|
1.0%
1/99 • 12-16 weeks
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
|
Vascular disorders
Hypotension
|
0.97%
1/103 • 12-16 weeks
|
0.00%
0/99 • 12-16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60