A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

• Sponsor: Kowa Research Institute, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01301066
• Collaborator: Kowa Pharmaceuticals America, Inc. (Industry), Eli Lilly and Company (Industry)
• Enrollment: 252
• Locations: 35
• Arms: 2
• Duration (Months): 27
• Patients Per Site: 7.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Drug: Pitavastatin; Drug: Pravastatin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pitavastatin 4 mg QD	Drug: Pitavastatin; Pitavastatin 4 mg QD; Other Names: Livalo
Active Comparator: Pravastatin 40 mg QD	Drug: Pravastatin; Pravastatin 40 mg QD

Outcome Measures

Primary Outcome Measures

1. Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks [12 weeks minus baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.

• Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception

• Documented HIV infection.

Exclusion Criteria:

• Homozygous familial hypercholesterolemia

• Any conditions that may cause secondary dyslipidemia

• History of coronary artery disease (CAD) or CAD equivalent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Beverly Hills	California	United States
3		Costa Mesa	California	United States
4		Long Beach	California	United States
5		Los Angeles	California	United States
6		Newport Beach	California	United States
7		San Francisco	California	United States
8		Washington	District of Columbia	United States
9		Coral Gables	Florida	United States
10		Fort Lauderdale	Florida	United States
11		Fort Pierce	Florida	United States
12		Miami Beach	Florida	United States
13		Miami	Florida	United States
14		Tampa	Florida	United States
15		Vero Beach	Florida	United States
16		Atlanta	Georgia	United States
17		Decatur	Georgia	United States
18		Springfield	Massachusetts	United States
19		Berkley	Michigan	United States
20		St. Louis	Missouri	United States
21		Hillsborough	New Jersey	United States
22		Randolph	New Jersey	United States
23		New York	New York	United States
24		Rochester	New York	United States
25		Huntersville	North Carolina	United States
26		Addison	Texas	United States
27		Austin	Texas	United States
28		Corpus Christi	Texas	United States
29		Fort Worth	Texas	United States
30		Harlingen	Texas	United States
31		Houston	Texas	United States
32		Longview	Texas	United States
33		Annandale	Virginia	United States
34		Seattle	Washington	United States
35		Spokane	Washington	United States

Sponsors and Collaborators

• Kowa Research Institute, Inc.
• Kowa Pharmaceuticals America, Inc.
• Eli Lilly and Company

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kowa Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT01301066
• Other Study ID Numbers: NK-104-4.05US
• First Posted: Feb 23, 2011
• Last Update Posted: Apr 29, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Dyslipidemias; Pravastatin; Pitavastatin

Study Results

Participant Flow

Arm/Group Title	Pitavastatin 4 mg QD	Pravastatin 40 mg QD
Arm/Group Description	Pitavastatin: Pitavastatin 4 mg QD	Pravastatin: Pravastatin 40 mg QD
Period Title: Overall Study
STARTED	126	126
COMPLETED	99	91
NOT COMPLETED	27	35

Baseline Characteristics

Arm/Group Title	Pitavastatin 4 mg QD	Pravastatin 40 mg QD	Total
Arm/Group Description	Pitavastatin: Pitavastatin 4 mg QD	Pravastatin: Pravastatin 40 mg QD	Total of all reporting groups
Overall Participants	126	126	252
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	126 100%	126 100%	252 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	20 15.9%	15 11.9%	35 13.9%
Male	106 84.1%	111 88.1%	217 86.1%
Region of Enrollment (participants) [Number]
United States	126 100%	126 100%	252 100%

Outcome Measures

1. Primary Outcome

Title	Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
Time Frame	12 weeks minus baseline

Outcome Measure Data

Analysis Population Description

modified Intent To Treat (mITT) population included all randomized subjects who received at least 1 dose of study drug and had at least 1 on-treatment lipid assessment

Arm/Group Title	Pitavastatin 4 mg QD	Pravastatin 40 mg QD
Arm/Group Description	Pitavastatin: Pitavastatin 4 mg QD	Pravastatin: Pravastatin 40 mg QD
Measure Participants	121	126
Mean (Standard Deviation) [mg/dL]	155.1 (25.93)	154.6 (23.91)

Adverse Events

Arm/Group Title	Pitavastatin 4 mg QD		Pravastatin 40 mg QD
Arm/Group Description	Pitavastatin: Pitavastatin 4 mg QD		Pravastatin: Pravastatin 40 mg QD
All Cause Mortality
	Pitavastatin 4 mg QD		Pravastatin 40 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pitavastatin 4 mg QD		Pravastatin 40 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/126 (5.6%)		3/126 (2.4%)
Cardiac disorders
Arteriosclerosis coronary artery	0/126 (0%)	0	1/126 (0.8%)	1
Atrial septal defect	1/126 (0.8%)	1	0/126 (0%)	0
Chest pain	1/126 (0.8%)	1	0/126 (0%)	0
Myocardial infarction	0/126 (0%)	0	1/126 (0.8%)	1
Gastrointestinal disorders
Diverticulitis	1/126 (0.8%)	1	0/126 (0%)	0
Enterovesical fistula	1/126 (0.8%)	1	0/126 (0%)	0
Gastroenteritis	1/126 (0.8%)	1	0/126 (0%)	0
Gastroenteritis viral	1/126 (0.8%)	1	0/126 (0%)	0
Infections and infestations
Herpes dermatitis	1/126 (0.8%)	1	0/126 (0%)	0
Musculoskeletal and connective tissue disorders
Multiple fractures	1/126 (0.8%)	1	0/126 (0%)	0
Muscle haemorrhage	0/126 (0%)	0	1/126 (0.8%)	1
Nervous system disorders
Cerebrovascular accident	0/126 (0%)	0	1/126 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/126 (0.8%)	1	0/126 (0%)	0
Respiratory failure	1/126 (0.8%)	1	0/126 (0%)	0
Vascular disorders
Transient ischaemic attack	1/126 (0.8%)	1	0/126 (0%)	0
Other (Not Including Serious) Adverse Events
	Pitavastatin 4 mg QD		Pravastatin 40 mg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/126 (7.9%)		5/126 (4%)
Blood and lymphatic system disorders
Blood CK increased	2/126 (1.6%)		0/126 (0%)
Gastrointestinal disorders
Upper abdominal pain	2/126 (1.6%)		0/126 (0%)
Diarrhoea	2/126 (1.6%)		0/126 (0%)
Nausea	1/126 (0.8%)		3/126 (2.4%)
General disorders
Fatigue	2/126 (1.6%)		1/126 (0.8%)
Headache	2/126 (1.6%)		1/126 (0.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor shall have the right to the first publication of the results of the Study. PI may publish, however PI must submit publication to sponsor for review at least 60 days prior to proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary.