Trial Outcomes & Findings for Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia (NCT NCT01256476)

NCT ID: NCT01256476

Last Updated: 2012-05-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 328 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2012-05-08

Participant Flow

Participant milestones

Measure	Pitavastatin 4 mg Once a Day (QD)	Pravastatin 40 mg Once a Day (QD)
Overall Study STARTED	164	164
Overall Study COMPLETED	158	157
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Measure	Pitavastatin 4 mg Once a Day (QD)	Pravastatin 40 mg Once a Day (QD)
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	1	2
Overall Study Persistent ALT or AST elevation	1	0
Overall Study Physician Decision	0	1
Overall Study Subject non-compliance	0	1
Overall Study LDL-C elevation exceeding 250 mg/dL	0	1

Baseline Characteristics

Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia

Baseline characteristics by cohort

Measure	Pitavastatin 4 mg Once a Day (QD) n=164 Participants	Pravastatin 40 mg Once a Day (QD) n=164 Participants	Total n=328 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	122 Participants n=5 Participants	127 Participants n=7 Participants	249 Participants n=5 Participants
Age, Categorical >=65 years	42 Participants n=5 Participants	37 Participants n=7 Participants	79 Participants n=5 Participants
Age Continuous	58.8 years STANDARD_DEVIATION 8.93 • n=5 Participants	57.0 years STANDARD_DEVIATION 10.23 • n=7 Participants	57.9 years STANDARD_DEVIATION 9.63 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	79 Participants n=7 Participants	162 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants	85 Participants n=7 Participants	166 Participants n=5 Participants
Region of Enrollment United States	164 participants n=5 Participants	164 participants n=7 Participants	328 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: All randomized subjects who took at least 1 dose of double-blind study drug, had a baseline efficacy measurement, and had at least 1 valid post-baseline efficacy measurement.

Outcome measures

Measure	Pitavastatin 4 mg Once Daily (QD) n=161 Participants	Pravastatin 40 mg Once Daily (QD) n=161 Participants
Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12	-34.8 percent Standard Error 1.20	-22.7 percent Standard Error 1.22

Adverse Events

Pitavastatin 4 mg Once a Day (QD)

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Pravastatin 40 mg Once a Day (QD)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pitavastatin 4 mg Once a Day (QD) n=164 participants at risk	Pravastatin 40 mg Once a Day (QD) n=164 participants at risk
Gastrointestinal disorders appendicitis perforated	0.61% 1/164	0.00% 0/164
Neoplasms benign, malignant and unspecified (incl cysts and polyps) prostate cancer	0.61% 1/164	0.00% 0/164
Musculoskeletal and connective tissue disorders lumbar spinal stenosis	0.00% 0/164	0.61% 1/164

Other adverse events

Measure	Pitavastatin 4 mg Once a Day (QD) n=164 participants at risk	Pravastatin 40 mg Once a Day (QD) n=164 participants at risk
Infections and infestations upper respiratory tract infection	4.9% 8/164	5.5% 9/164
Infections and infestations Nasopharyngitis	6.7% 11/164	3.0% 5/164

Additional Information

Roger Morgan, MD, FACS

Kowa Research Institute, Inc.

Phone: 919-433-1600

Email: RMorgan@KowaUS.com

Results disclosure agreements

• Principal investigator is a sponsor employee May not publish.
• Publication restrictions are in place

Restriction type: OTHER