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Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01043094
Recruitment Status : Completed
First Posted : January 6, 2010
Results First Posted : August 13, 2012
Last Update Posted : August 13, 2012
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Brief Summary:

This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B):

The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the ranges for comparison will be obtained from the pooled demographic data of the renally impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A, the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men to women in Group B will be the same as in Group A.

Condition or disease Intervention/treatment Phase
Severe Renal Impairment Drug: Pitavastatin 4mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Study to Compare the Safety, Tolerability, and Pharmacokinetic Profile of a Single Oral Dose of Pitavastatin 4 mg in Adult Volunteers With Severe Renal Impairment Who Are Not Being Treated With Hemodialysis Versus Healthy Adult Volunteers
Study Start Date : December 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pitavastatin 4mg renal impaired
Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
Drug: Pitavastatin 4mg
Pitavastatin 4mg single dose

Active Comparator: Pitavastatin 4mg healthy subjects
Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
Drug: Pitavastatin 4mg
Pitavastatin 4mg single dose

Primary Outcome Measures :
  1. Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL)) [ Time Frame: 48 hours ]
    Area under the curve from start to elimination for Pitavastatin.

Secondary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events [ Time Frame: 3 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject is an adult male or female subject aged 18 years or older. Females of childbearing potential must have a negative pregnancy test before beginning the study.
  • Subject has no clinically significant medical conditions (other than renal impairment and associated diseases, such as hypertension, diabetes, and dyslipidemia, for subjects in Group A) as determined by medical history, physical examination, 12-lead ECG, clinical laboratory results (hematology, serum chemistry, and urinalysis [if able to pass urine]), and serology results (hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus types 1 and 2 antibody). Subjects with positive results for hepatitis C virus but who have normal liver enzymes will not be excluded. Any subjects who have impaired hepatic function that will potentially affect drug metabolism should be excluded.
  • Subject provides written informed consent before any study-specific evaluation is performed.
  • Subject is able and willing to comply with the protocol and study procedures.

Exclusion Criteria:

  • Subject is on maintenance hemodialysis.
  • Subject has a BMI of >37 kg/m2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01043094

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United States, Minnesota
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.

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Responsible Party: Kowa Research Institute, Inc. Identifier: NCT01043094     History of Changes
Other Study ID Numbers: NK-104-4.01US
First Posted: January 6, 2010    Key Record Dates
Results First Posted: August 13, 2012
Last Update Posted: August 13, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents