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

This study has been completed.

Study NCT00309751 Information provided by Kowa Research Europe

First Received on December 8, 2005. Last Updated on February 17, 2010 History of Changes

Results First Received: August 26, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Type II Diabetes Mellitus Dyslipidemia
Interventions:	Drug: Pitavastatin Drug: Atorvastatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Pitavastatin 4 mg QD	Pitavastatin 4 mg once daily
Atorvastatin 20 mg QD	Atorvastatin 20 mg once daily

Participant Flow: Overall Study

	Pitavastatin 4 mg QD	Atorvastatin 20 mg QD
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

Baseline Characteristics

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Reporting Groups

	Description
Pitavastatin 4 mg QD	Pitavastatin 4 mg once daily
Atorvastatin 20 mg QD	Atorvastatin 20 mg once daily

Baseline Measures

	Pitavastatin 4 mg QD	Atorvastatin 20 mg QD	Total
Number of Participants [units: participants]	275	137	412
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	191	93	284
>=65 years	84	44	128
Age [units: years] Mean ± Standard Deviation	59.1 ± 9.21	59.8 ± 9.06	59.4 ± 9.15
Gender [units: participants]
Female	120	59	179
Male	155	78	233

Outcome Measures

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1. Primary:

Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 12 weeks ]

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2. Secondary:

Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target [ Time Frame: 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Bill Arana
Organization: Kowa Research Institute Inc
phone: 919 433 1600
e-mail: barana@kowaus.com

No publications provided

Responsible Party:	Dragos Budinski, MD, Kowa Research Europe
ClinicalTrials.gov Identifier:	NCT00309751 History of Changes
Other Study ID Numbers:	NK-104-305
Study First Received:	December 8, 2005
Results First Received:	August 26, 2009
Last Updated:	February 17, 2010
Health Authority:	Poland: Ministry of Health; Germany: Ethics Commission; India: Indian Council of Medical Research