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Trial record 20 of 3094 for:    Area Under Curve AND Healthy

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

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ClinicalTrials.gov Identifier: NCT01043094
Recruitment Status : Completed
First Posted : January 6, 2010
Results First Posted : August 13, 2012
Last Update Posted : August 13, 2012
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Severe Renal Impairment
Intervention Drug: Pitavastatin 4mg
Enrollment 16
Recruitment Details Study period was from 23 November 2009 to 07 June 2010 All subjects were seen at a medical clinic
Pre-assignment Details  
Arm/Group Title Pitavastatin 4mg Renal Impaired Pitavastatin 4mg Healthy Subjects
Hide Arm/Group Description 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 Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
Period Title: Overall Study
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title Pitavastatin 4mg Renal Impaired Pitavastatin 4mg Healthy Subjects Total
Hide Arm/Group Description 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 Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2) Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  75.0%
8
 100.0%
14
  87.5%
>=65 years
2
  25.0%
0
   0.0%
2
  12.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
54.1  (15.41) 52.0  (2.62) 53.1  (10.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
3
  37.5%
3
  37.5%
6
  37.5%
Male
5
  62.5%
5
  62.5%
10
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
1.Primary Outcome
Title Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))
Hide Description Area under the curve from start to elimination for Pitavastatin.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pitavastatin 4mg Renal Impaired Pitavastatin 4mg Healthy Subjects
Hide Arm/Group Description:
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
Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: nanogram hour per milliliter (ng•h/mL)
175  (39) 145  (55)
2.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide Description [Not Specified]
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pitavastatin 4mg Renal Impaired Pitavastatin 4mg Healthy Subjects
Hide Arm/Group Description:
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
Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
Overall Number of Participants Analyzed 8 8
Measure Type: Number
Unit of Measure: Participants
3 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pitavastatin 4mg Renal Impaired Pitavastatin 4mg Healthy Subjects
Hide Arm/Group Description 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 Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
All-Cause Mortality
Pitavastatin 4mg Renal Impaired Pitavastatin 4mg Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pitavastatin 4mg Renal Impaired Pitavastatin 4mg Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pitavastatin 4mg Renal Impaired Pitavastatin 4mg Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   3/8 (37.50%)   1/8 (12.50%) 
Gastrointestinal disorders     
Diarrhea  1/8 (12.50%)  0/8 (0.00%) 
Nausea  1/8 (12.50%)  0/8 (0.00%) 
Vomiting  1/8 (12.50%)  0/8 (0.00%) 
General disorders     
Fatigue  1/8 (12.50%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia  0/8 (0.00%)  1/8 (12.50%) 
Renal and urinary disorders     
Polyuria  1/8 (12.50%)  0/8 (0.00%) 
1
Term from vocabulary, Medra
2
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI not to publish.
Results Point of Contact
Name/Title: Roger Morgan, MD, FACS
Organization: Kowa Research Institute, Inc.
Phone: 919-433-1600
Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01043094     History of Changes
Other Study ID Numbers: NK-104-4.01US
First Submitted: December 18, 2009
First Posted: January 6, 2010
Results First Submitted: March 23, 2012
Results First Posted: August 13, 2012
Last Update Posted: August 13, 2012