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Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

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ClinicalTrials.gov Identifier: NCT00309751
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : January 18, 2010
Last Update Posted : February 23, 2010
Sponsor:
Information provided by:
Kowa Research Europe

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Type II Diabetes Mellitus
Dyslipidemia
Interventions Drug: Pitavastatin
Drug: Atorvastatin
Enrollment 418
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pitavastatin 4 mg QD Atorvastatin 20 mg QD
Hide Arm/Group Description Pitavastatin 4 mg once daily Atorvastatin 20 mg once daily
Period Title: Overall Study
Started 279 139
Safety Population 275 [1] 137 [1]
Completed 248 124
Not Completed 31 15
[1]
Subjects who received at least 1 dose of study drug
Arm/Group Title Pitavastatin 4 mg QD Atorvastatin 20 mg QD Total
Hide Arm/Group Description Pitavastatin 4 mg once daily Atorvastatin 20 mg once daily Total of all reporting groups
Overall Number of Baseline Participants 275 137 412
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 137 participants 412 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
191
  69.5%
93
  67.9%
284
  68.9%
>=65 years
84
  30.5%
44
  32.1%
128
  31.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 275 participants 137 participants 412 participants
59.1  (9.21) 59.8  (9.06) 59.4  (9.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 137 participants 412 participants
Female
120
  43.6%
59
  43.1%
179
  43.4%
Male
155
  56.4%
78
  56.9%
233
  56.6%
1.Primary Outcome
Title Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
Hide Description Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pitavastatin 4 mg QD Atorvastatin 20 mg QD
Hide Arm/Group Description:
Pitavastatin 4 mg once daily
Atorvastatin 20 mg once daily
Overall Number of Participants Analyzed 274 136
Mean (Standard Deviation)
Unit of Measure: percent change
-40.78  (19.599) -43.25  (16.378)
2.Secondary Outcome
Title Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target
Hide Description Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pitavastatin 4 mg QD Atorvastatin 20 mg QD
Hide Arm/Group Description:
Pitavastatin 4 mg once daily
Atorvastatin 20 mg once daily
Overall Number of Participants Analyzed 274 136
Measure Type: Number
Unit of Measure: Participants
212 111
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pitavastatin 4 mg QD Atorvastatin 20 mg QD
Hide Arm/Group Description Pitavastatin 4 mg once daily Atorvastatin 20 mg once daily
All-Cause Mortality
Pitavastatin 4 mg QD Atorvastatin 20 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pitavastatin 4 mg QD Atorvastatin 20 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   4   4 
Cardiac disorders     
Myocardial infarction * 1  1/275 (0.36%)  0/137 (0.00%) 
Tachycardia paroxysmal * 1  1/275 (0.36%)  0/137 (0.00%) 
General disorders     
Non-cardiac chest pain * 1  0/275 (0.00%)  1/137 (0.73%) 
Infections and infestations     
Gastroenteritis * 1  1/275 (0.36%)  0/137 (0.00%) 
Injury, poisoning and procedural complications     
Alcohol poisoning * 1  0/275 (0.00%)  1/137 (0.73%) 
Humerus fracture * 1  0/275 (0.00%)  1/137 (0.73%) 
Investigations     
Blood creatinine increased * 1  1/275 (0.36%)  0/137 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc disorder * 1  0/275 (0.00%)  1/137 (0.73%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Pitavastatin 4 mg QD Atorvastatin 20 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   29   22 
Gastrointestinal disorders     
Diarrhea * 1  6/275 (2.18%)  9/137 (6.57%) 
Infections and infestations     
Nasopharyngitis * 1  12/275 (4.36%)  9/137 (6.57%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  11/275 (4.00%)  0/137 (0.00%) 
Vascular disorders     
Hypertension * 1  0/275 (0.00%)  4/137 (2.92%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.1
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.
Results Point of Contact
Name/Title: Bill Arana
Organization: Kowa Research Institute Inc
Phone: 919 433 1600
Responsible Party: Dragos Budinski, MD, Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00309751     History of Changes
Other Study ID Numbers: NK-104-305
First Submitted: December 8, 2005
First Posted: April 3, 2006
Results First Submitted: August 26, 2009
Results First Posted: January 18, 2010
Last Update Posted: February 23, 2010