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

• Sponsor: Kowa Research Institute, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01256476
• Collaborator: (none)
• Enrollment: 328
• Locations: 44
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.

Condition or Disease	Intervention/Treatment	Phase
Primary Dyslipidemia; Mixed Dyslipidemia	Drug: pitavastatin; Drug: pravastatin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 328 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, PARALLEL GROUP STUDY OF PITAVASTATIN 4 MG VS. PRAVASTATIN 40 MG IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pitavastatin 4 mg once daily (QD)	Drug: pitavastatin; pitavastatin 4 mg once daily (QD); Other Names: Livalo
Active Comparator: pravastatin 40 mg once daily (QD)	Drug: pravastatin; Pravastatin 40 mg once daily (QD)

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 [Baseline and 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent

• Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL

Exclusion Criteria:

• Homozygous familial hypercholesterolemia

• Any conditions which may cause secondary dyslipidemia

• Uncontrolled diabetes mellitus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Huntsville	Alabama	United States
2		Muscle Shoals	Alabama	United States
3		Chandler	Arizona	United States
4		Goodyear	Arizona	United States
5		Phoenix	Arizona	United States
6		Beverly Hills	California	United States
7		Los Angeles	California	United States
8		Newport Beach	California	United States
9		Colorado Springs	Colorado	United States
10		Clearwater	Florida	United States
11		Deland	Florida	United States
12		Fort Luaderdale	Florida	United States
13		Jacksonville	Florida	United States
14		Miami	Florida	United States
15		Ovido	Florida	United States
16		Pembroke Pines	Florida	United States
17		Ponte Vedra	Florida	United States
18		Addison	Illinois	United States
19		Chicago	Illinois	United States
20		Evansville	Indiana	United States
21		Indianapolis	Indiana	United States
22		Kansas City	Kansas	United States
23		Erlanger	Kentucky	United States
24		Baltimore	Maryland	United States
25		Brockton	Massachusetts	United States
26		Edina	Minnesota	United States
27		Las Vegas	Nevada	United States
28		Berlin	New Jersey	United States
29		Rochester	New York	United States
30		Statesville	North Carolina	United States
31		Cincinnati	Ohio	United States
32		Lyndhurst	Ohio	United States
33		Willoughby Hills	Ohio	United States
34		Tulsa	Oklahoma	United States
35		Eugene	Oregon	United States
36		Greer	South Carolina	United States
37		Mt. Pleasant	South Carolina	United States
38		Corpus Christi	Texas	United States
39		Dallas	Texas	United States
40		San Antonio	Texas	United States
41		Salt Lake City	Utah	United States
42		Norfolk	Virginia	United States
43		Richmond	Virginia	United States
44		Olympia	Washington	United States

Sponsors and Collaborators

• Kowa Research Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kowa Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT01256476
• Other Study ID Numbers: NK-104-4.04US
• First Posted: Dec 8, 2010
• Last Update Posted: May 8, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Pravastatin; Pitavastatin

Study Results

Participant Flow

Arm/Group Title	Pitavastatin 4 mg Once a Day (QD)	Pravastatin 40 mg Once a Day (QD)
Arm/Group Description
Period Title: Overall Study
STARTED	164	164
COMPLETED	158	157
NOT COMPLETED	6	7

Baseline Characteristics

Arm/Group Title	Pitavastatin 4 mg Once a Day (QD)	Pravastatin 40 mg Once a Day (QD)	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	164	164	328
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	122 74.4%	127 77.4%	249 75.9%
>=65 years	42 25.6%	37 22.6%	79 24.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.8 (8.93)	57.0 (10.23)	57.9 (9.63)
Sex: Female, Male (Count of Participants)
Female	83 50.6%	79 48.2%	162 49.4%
Male	81 49.4%	85 51.8%	166 50.6%
Region of Enrollment (participants) [Number]
United States	164 100%	164 100%	328 100%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pitavastatin 4 mg Once Daily (QD)	Pravastatin 40 mg Once Daily (QD)
Arm/Group Description
Measure Participants	161	161
Mean (Standard Error) [percent]	-34.8 (1.20)	-22.7 (1.22)

Adverse Events

Arm/Group Title	Pitavastatin 4 mg Once a Day (QD)		Pravastatin 40 mg Once a Day (QD)
Arm/Group Description
All Cause Mortality
	Pitavastatin 4 mg Once a Day (QD)		Pravastatin 40 mg Once a Day (QD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pitavastatin 4 mg Once a Day (QD)		Pravastatin 40 mg Once a Day (QD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/164 (1.2%)		1/164 (0.6%)
Gastrointestinal disorders
appendicitis perforated	1/164 (0.6%)		0/164 (0%)
Musculoskeletal and connective tissue disorders
lumbar spinal stenosis	0/164 (0%)		1/164 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer	1/164 (0.6%)		0/164 (0%)
Other (Not Including Serious) Adverse Events
	Pitavastatin 4 mg Once a Day (QD)		Pravastatin 40 mg Once a Day (QD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/164 (11.6%)		14/164 (8.5%)
Infections and infestations
upper respiratory tract infection	8/164 (4.9%)		9/164 (5.5%)
Nasopharyngitis	11/164 (6.7%)		5/164 (3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

May not publish.