Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

This study has been completed.

Study NCT00309738 Information provided by Kowa Research Europe

First Received on December 8, 2005. Last Updated on March 9, 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:	Hypercholesterolemia Dyslipidemia
Interventions:	Drug: pitavastatin Drug: simvastatin

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
Subjects were enrolled from September 2005 to October 2006 at 43 investigator sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who qualified entered a 6-8 week wash-out/dietary lead-in period followed by a 12- week treatment period. Patients were randomly assigned to one of the two treatment groups: pitavastatin 4 mg QD, or simvastatin 40 mg QD in a ratio of 2:1.

Reporting Groups

	Description
Pitavastatin 4 mg QD	Pitavastatin 4 mg once daily
Simvastatin 40 mg QD	Simvastatin 40 mg once daily

Participant Flow: Overall Study

	Pitavastatin 4 mg QD	Simvastatin 40 mg QD
STARTED	236	119
Safety Population	233 ^[1]	119 ^[1]
COMPLETED	223	107
NOT COMPLETED	13	12

[1]	Subjects who received at least one dose of study medication

Baseline Characteristics

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Reporting Groups

	Description
Pitavastatin 4 mg QD	Pitavastatin 4 mg once daily
Simvastatin 40 mg QD	Simvastatin 40 mg once daily

Baseline Measures

	Pitavastatin 4 mg QD	Simvastatin 40 mg QD	Total
Number of Participants [units: participants]	233	119	352
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	184	88	272
>=65 years	49	31	80
Age [units: years] Mean ± Standard Deviation	60.1 ± 6.82	60.9 ± 6.78	60.3 ± 6.81
Gender [units: participants]
Female	75	37	112
Male	158	82	240

Outcome Measures

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1. Primary:

Percent Change From Baseline in LDL-C [ Time Frame: 12 weeks ]

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2. Secondary:

Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) [ 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
phone: 919 433 1600
e-mail: barana@kowaus.com

No publications provided by Kowa Research Europe

Publications automatically indexed to this study:

Eriksson M, Budinski D, Hounslow N. Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. Adv Ther. 2011 Sep;28(9):811-23. Epub 2011 Aug 25.

Responsible Party:	Neil Hounslow, Kowa Research Europe
ClinicalTrials.gov Identifier:	NCT00309738 History of Changes
Other Study ID Numbers:	NK-104-304
Study First Received:	December 8, 2005
Results First Received:	August 26, 2009
Last Updated:	March 9, 2010
Health Authority:	Sweden: Medical Products Agency; Spain: Spanish Agency of Medicines