Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin (NCT NCT00309738)

NCT ID: NCT00309738

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: 355 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2010-03-16

Participant Flow

Subjects were enrolled from September 2005 to October 2006 at 43 investigator sites.

Patients who qualified entered a 6-8 week wash-out/dietary lead-in period followed by a 12- week treatment period. Patients were randomly assigned to one of the two treatment groups: pitavastatin 4 mg QD, or simvastatin 40 mg QD in a ratio of 2:1.

Participant milestones

Measure	Pitavastatin 4 mg QD Pitavastatin 4 mg once daily	Simvastatin 40 mg QD Simvastatin 40 mg once daily
Overall Study STARTED	236	119
Overall Study Safety Population	233	119
Overall Study COMPLETED	223	107
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Baseline characteristics by cohort

Measure	Pitavastatin 4 mg QD n=233 Participants Pitavastatin 4 mg once daily	Simvastatin 40 mg QD n=119 Participants Simvastatin 40 mg once daily	Total n=352 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	184 Participants n=5 Participants	88 Participants n=7 Participants	272 Participants n=5 Participants
Age, Categorical >=65 years	49 Participants n=5 Participants	31 Participants n=7 Participants	80 Participants n=5 Participants
Age Continuous	60.1 years STANDARD_DEVIATION 6.82 • n=5 Participants	60.9 years STANDARD_DEVIATION 6.78 • n=7 Participants	60.3 years STANDARD_DEVIATION 6.81 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	37 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	158 Participants n=5 Participants	82 Participants n=7 Participants	240 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Subjects who completed the treatment period

Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Outcome measures

Measure	Pitavastatin 4 mg QD n=223 Participants Pitavastatin 4 mg once daily	Simvastatin 40 mg QD n=107 Participants Simvastatin 40 mg once daily
Percent Change From Baseline in LDL-C	-43.96 mg/dL Standard Deviation 12.770	-43.77 mg/dL Standard Deviation 14.416

SECONDARY outcome

Timeframe: 12 weeks

Population: Full analysis set (FAS)

Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)

Outcome measures

Measure	Pitavastatin 4 mg QD n=233 Participants Pitavastatin 4 mg once daily	Simvastatin 40 mg QD n=118 Participants Simvastatin 40 mg once daily
Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)	203 participants	101 participants

Adverse Events

Pitavastatin 4 mg QD

Serious events: 4 serious events

Other events: 51 other events

Deaths: 0 deaths

Simvastatin 40 mg QD

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pitavastatin 4 mg QD Pitavastatin 4 mg once daily	Simvastatin 40 mg QD Simvastatin 40 mg once daily
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/233	0.84% 1/119
Cardiac disorders Acute coronary syndrome	0.43% 1/233	0.00% 0/119
Cardiac disorders Myocardial infarction	0.43% 1/233	0.00% 0/119
Gastrointestinal disorders Gastritis	0.43% 1/233	0.00% 0/119
Hepatobiliary disorders cholelithiasis	0.00% 0/233	0.84% 1/119
Infections and infestations Cystitis	0.00% 0/233	0.84% 1/119
Infections and infestations peritonsilar abscess	0.43% 1/233	0.00% 0/119
Nervous system disorders Syncope	0.00% 0/233	0.84% 1/119
Vascular disorders Aortic aneurysm	0.00% 0/233	0.84% 1/119

Other adverse events

Measure	Pitavastatin 4 mg QD Pitavastatin 4 mg once daily	Simvastatin 40 mg QD Simvastatin 40 mg once daily
Gastrointestinal disorders Consitpation	4.3% 10/233	1.7% 2/119
Musculoskeletal and connective tissue disorders Myalgia	3.0% 7/233	4.2% 5/119
Infections and infestations Nasopharyngitis	4.7% 11/233	2.5% 3/119
Nervous system disorders Headache	5.6% 13/233	2.5% 3/119
Vascular disorders Hypertension	4.3% 10/233	0.00% 0/119

Additional Information

Bill Arana

Kowa Research Institute

Phone: 919 433 1600

Email: barana@kowaus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60