Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

This study has been completed.

Sponsor:

Information provided by:

Kowa Research Europe

ClinicalTrials.gov Identifier:

NCT00344370

First received: June 23, 2006

Last updated: January 25, 2010

Last verified: January 2010

History of Changes

Results First Received: September 1, 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	Pitavastatin 4 mg once daily
Atorvastatin 40 mg	Atorvastatin 40 mg once daily

Participant Flow: Overall Study

	Pitavastatin 4 mg	Atorvastatin 40 mg
STARTED	143	71
COMPLETED	128	68
NOT COMPLETED	15	3

Baseline Characteristics

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Reporting Groups

	Description
Pitavastatin 4 mg	Pitavastatin 4 mg once daily
Atorvastatin 40 mg	Atorvastatin 40 mg once daily
Total	Total of all reporting groups

Baseline Measures

	Pitavastatin 4 mg	Atorvastatin 40 mg	Total
Number of Participants [units: participants]	143	71	214
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	95	46	141
>=65 years	48	25	73
Age [units: years] Mean ± Standard Deviation	59.3 ± 9.83	60.0 ± 9.21	59.5 ± 9.61
Gender [units: participants]
Female	68	30	98
Male	75	41	116

Outcome Measures

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1. Primary:

NCEP LDL-C Target Attainment [ Time Frame: 44 weeks ]

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2. Secondary:

Percent Change From Baseline in LDL-C [ Time Frame: Basseline to 44 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
phone: 919 433-1600
e-mail: barana@kowaus.com

No publications provided

Responsible Party:	Dragos Budinski, MD, Kowa Research Europe
ClinicalTrials.gov Identifier:	NCT00344370 History of Changes
Other Study ID Numbers:	NK-104-310
Study First Received:	June 23, 2006
Results First Received:	September 1, 2009
Last Updated:	January 25, 2010
Health Authority:	Poland: Ministry of Health Germany: Ethics Commission India: Indian Council of Medical Research

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