Trial · NCT00249249

Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels

NCT00249249, Phase 3, Completed, Kowa Research Europe; results first posted 2009-12-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels. Trials, record NCT00249249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00249249

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
NCT number: NCT00249249
Status: Completed
Phases: Phase 3
Enrollment: 830 participants, actual
Lead sponsor: Kowa Research Europe
Conditions: Primary Hypercholesterolemia, Dyslipidemia
Interventions: Pitavastatin, Atorvastatin
First posted: 2005-11-07
Last updated: 2010-01-12
Other registries' IDs: eudract:2005-001000-39
Results first posted: 2009-12-16

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12	Baseline to 12 weeks
Secondary	Percent Change From Baseline in Total Cholesterol (TC)	Baseline to 12 Weeks	Percent change in total cholesterol from baseline to Week 12
Secondary	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)	Baseline to 12 weeks	percent change from baseline in high density lipoprotein-cholesterol (HDL-C)
Secondary	TC:HDL-C Ratio	12 weeks	Ratio of mean total cholesterol to mean HDL-C at 12 weeks
Secondary	Triglycerides (TG)	12 weeks	mean triglycerides at 12 weeks
Secondary	Non-HDL:HDL Ratio	12 weeks	Ratio of non-HDL to HDL at 12 weeks
Secondary	Apolipoprotein B (Apo B)	12 weeks	Apolipoprotein B at 12 weeks
Secondary	Apolipoprotein-A1 (Apo-A1)	12 weeks	Apolipoprotein-A1 at 12 weeks
Secondary	Apo-B:Apo-A1 Ratio	12 weeks	Ratio of Apo-B to Apo-A1 at 12 weeks
Secondary	High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks	12 weeks	high sensitivity C-reactive protein (hs-CRP) at 12 weeks

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12	Baseline to 12 weeks	All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.	percent change	MEAN
SECONDARY	Percent Change From Baseline in Total Cholesterol (TC)	Baseline to 12 Weeks	All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.	percent change	MEAN
SECONDARY	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)	Baseline to 12 weeks	All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.	percent change	MEAN
SECONDARY	TC:HDL-C Ratio	12 weeks	All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.	ratio	MEAN
SECONDARY	Triglycerides (TG)	12 weeks	All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.	mg/dL	MEAN
SECONDARY	Non-HDL:HDL Ratio	12 weeks	All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.		MEAN
SECONDARY	Apolipoprotein B (Apo B)	12 weeks	All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.	mg/dL	MEAN
SECONDARY	Apolipoprotein-A1 (Apo-A1)	12 weeks	All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.	mg/dL	MEAN
SECONDARY	Apo-B:Apo-A1 Ratio	12 weeks	All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.	ratio	MEAN
SECONDARY	High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks	12 weeks	All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.	mg/L	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12	Pitavastatin 2 mg QD	-37.89	Standard Deviation 13.841	percent change
Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12	Atorvastatin 10 mg QD	-38.76	Standard Deviation 14.582	percent change
Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12	Pitavastatin 4 mg QD	-45.5	Standard Deviation 14.005	percent change
Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12	Atorvastatin 20 mg QD	-43.9	Standard Deviation 15.853	percent change
Percent Change From Baseline in Total Cholesterol (TC)	Pitavastatin 2 mg QD	-27.57	Standard Deviation 10.359	percent change
Percent Change From Baseline in Total Cholesterol (TC)	Atorvastatin 10 mg QD	-28.92	Standard Deviation 11.441	percent change
Percent Change From Baseline in Total Cholesterol (TC)	Pitavastatin 4 mg QD	-33.09	Standard Deviation 10.732	percent change
Percent Change From Baseline in Total Cholesterol (TC)	Atorvastatin 20 mg QD	-32.99	Standard Deviation 12.073	percent change
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)	Pitavastatin 2 mg QD	4.28	Standard Deviation 16.501	percent change
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)	Atorvastatin 10 mg QD	3.42	Standard Deviation 16.820	percent change

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pitavastatin 2 mg QD	321
Overall Study	STARTED	Atorvastatin 10 mg QD	103
Overall Study	STARTED	Pitavastatin 4 mg QD	303
Overall Study	STARTED	Atorvastatin 20 mg QD	103
Overall Study	Safety Population	Pitavastatin 2 mg QD	316
Overall Study	Safety Population	Atorvastatin 10 mg QD	102
Overall Study	Safety Population	Pitavastatin 4 mg QD	300
Overall Study	Safety Population	Atorvastatin 20 mg QD	103
Overall Study	COMPLETED	Pitavastatin 2 mg QD	301
Overall Study	COMPLETED	Atorvastatin 10 mg QD	98

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	constipation	Gastrointestinal disorders	Pitavastatin 2 mg QD	7	316
other	constipation	Gastrointestinal disorders	Atorvastatin 10 mg QD	1	102
other	constipation	Gastrointestinal disorders	Pitavastatin 4 mg QD	3	300
other	constipation	Gastrointestinal disorders	Atorvastatin 20 mg QD	0	103
other	nasopharyngitis	Infections and infestations	Pitavastatin 2 mg QD	10	316
other	nasopharyngitis	Infections and infestations	Atorvastatin 10 mg QD	4	102
other	nasopharyngitis	Infections and infestations	Pitavastatin 4 mg QD	8	300
other	nasopharyngitis	Infections and infestations	Atorvastatin 20 mg QD	3	103
other	myalgia	Musculoskeletal and connective tissue disorders	Pitavastatin 2 mg QD	5	316
other	myalgia	Musculoskeletal and connective tissue disorders	Atorvastatin 10 mg QD	1	102

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pitavastatin 2 mg QD
Total, all-cause mortality	Atorvastatin 10 mg QD
Total, all-cause mortality	Pitavastatin 4 mg QD
Total, all-cause mortality	Atorvastatin 20 mg QD
Total, other adverse events	Pitavastatin 2 mg QD	22	316
Total, other adverse events	Atorvastatin 10 mg QD	6	102
Total, other adverse events	Pitavastatin 4 mg QD	17	300
Total, other adverse events	Atorvastatin 20 mg QD	4	103
Total, serious adverse events	Pitavastatin 2 mg QD	3	316
Total, serious adverse events	Atorvastatin 10 mg QD	1	102

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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