Trial · NCT00330876
Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
NCT00330876, Phase 3, Completed, Kowa Research Europe; results first posted 2010-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia. Trials, record NCT00330876. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00330876
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
- NCT number
- NCT00330876
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 545 participants, actual
- Lead sponsor
- Kowa Research Europe
- Conditions
- Hypercholesterolemia, Dyslipidemias
- Interventions
- Pitavastatin
- First posted
- 2006-05-29
- Last updated
- 2010-03-16
- Results first posted
- 2010-01-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in LDL-C | Baseline to 60 weeks | percent change from baseline in low density lipoprotein-cholesterol (LDL-C) |
| Secondary | Change From Baseline in Total Cholesterol | Baseline to 60 weeks | Percent change from baseline in total cholesterol (TC) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in LDL-C | Baseline to 60 weeks | Subjects with measurement at Week 60 | percent change | MEAN |
| SECONDARY | Change From Baseline in Total Cholesterol | Baseline to 60 weeks | Subjects with a measurement at Week 60 | percent change | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in LDL-C | Pitavastatin 2 mg QD | -43.18 | Standard Deviation 10.065 | percent change | |
| Change From Baseline in LDL-C | Pitavastatin 4 mg QD | -44.26 | Standard Deviation 10.764 | percent change | |
| Change From Baseline in Total Cholesterol | Pitavastatin 2 mg QD | -28.27 | Standard Deviation 8.214 | percent change | |
| Change From Baseline in Total Cholesterol | Pitavastatin 4 mg QD | -30.54 | Standard Deviation 8.226 | percent change |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pitavastatin 2 mg QD | 449 | |
| Overall Study | STARTED | Pitavastatin 4 mg QD | 90 | |
| Overall Study | COMPLETED | Pitavastatin 2 mg QD | 378 | |
| Overall Study | COMPLETED | Pitavastatin 4 mg QD | 77 | |
| Overall Study | NOT COMPLETED | Pitavastatin 2 mg QD | 71 | |
| Overall Study | NOT COMPLETED | Pitavastatin 4 mg QD | 13 |
Source ClinicalTrials.gov
Adverse events132
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 | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Pitavastatin 2 mg QD | 71 | 539 | |
| other | Nasopharyngitis | Infections and infestations | Pitavastatin 4 mg QD | 2 | 95 | |
| other | Urinary tract infection | Infections and infestations | Pitavastatin 2 mg QD | 26 | 539 | |
| other | Urinary tract infection | Infections and infestations | Pitavastatin 4 mg QD | 4 | 95 | |
| other | Cystitis | Infections and infestations | Pitavastatin 2 mg QD | 26 | 539 | |
| other | Cystitis | Infections and infestations | Pitavastatin 4 mg QD | 1 | 95 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Pitavastatin 2 mg QD | 44 | 539 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Pitavastatin 4 mg QD | 4 | 95 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Pitavastatin 2 mg QD | 34 | 539 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Pitavastatin 4 mg QD | 3 | 95 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals6
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 | Pitavastatin 4 mg QD | ||
| Total, other adverse events | Pitavastatin 2 mg QD | 286 | |
| Total, other adverse events | Pitavastatin 4 mg QD | 24 | |
| Total, serious adverse events | Pitavastatin 2 mg QD | 51 | 449 |
| Total, serious adverse events | Pitavastatin 4 mg QD | 7 | 90 |
Source ClinicalTrials.gov
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pitavastatin 2 mg QD vs Pitavastatin 4 mg QD: serious adverse events |
Source Trial comparisons
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.
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.
GET https://conductscience.org/api/trials/v1/NCT00330876
GET https://conductscience.org/api/trials/v1/NCT00330876/events?page=2