Trial · NCT00344370
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
NCT00344370, 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. Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia. Trials, record NCT00344370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00344370
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
- NCT number
- NCT00344370
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 214 participants, actual
- Lead sponsor
- Kowa Research Europe
- Conditions
- Type II Diabetes Mellitus, Dyslipidemia
- Interventions
- Pitavastatin, Atorvastatin
- First posted
- 2006-06-26
- Last updated
- 2010-02-02
- 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 | NCEP LDL-C Target Attainment | 44 weeks | Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study. |
| Secondary | Percent Change From Baseline in LDL-C | Basseline to 44 weeks | Percent change from baseline in LDL-C at 44 weeks |
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 | NCEP LDL-C Target Attainment | 44 weeks | The efficacy population is defined as all patients who received at least one dose of study drug and who had at least one on-treatment lipid assessment | Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in LDL-C | Basseline to 44 weeks | 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 |
|---|---|---|---|---|---|
| NCEP LDL-C Target Attainment | Pitavastatin 4 mg | 110 | Participants | ||
| NCEP LDL-C Target Attainment | Atorvastatin 40 mg | 55 | Participants | ||
| Percent Change From Baseline in LDL-C | Pitavastatin 4 mg | -40.98 | Standard Deviation 19.053 | percent change | |
| Percent Change From Baseline in LDL-C | Atorvastatin 40 mg | -41.43 | Standard Deviation 21.159 | 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 4 mg | 143 | |
| Overall Study | STARTED | Atorvastatin 40 mg | 71 | |
| Overall Study | COMPLETED | Pitavastatin 4 mg | 128 | |
| Overall Study | COMPLETED | Atorvastatin 40 mg | 68 | |
| Overall Study | NOT COMPLETED | Pitavastatin 4 mg | 15 | |
| Overall Study | NOT COMPLETED | Atorvastatin 40 mg | 3 |
Source ClinicalTrials.gov
Adverse events46
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 | Myalgia/myalgia intercostal | Musculoskeletal and connective tissue disorders | Pitavastatin 4 mg | 6 | 143 | |
| other | Myalgia/myalgia intercostal | Musculoskeletal and connective tissue disorders | Atorvastatin 40 mg | 5 | 71 | |
| other | Naspopharyngitis | Musculoskeletal and connective tissue disorders | Pitavastatin 4 mg | 10 | 143 | |
| other | Naspopharyngitis | Musculoskeletal and connective tissue disorders | Atorvastatin 40 mg | 2 | 71 | |
| other | Arteriosclerosis | Vascular disorders | Pitavastatin 4 mg | 4 | 143 | |
| other | Arteriosclerosis | Vascular disorders | Atorvastatin 40 mg | 4 | 71 | |
| other | Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Pitavastatin 4 mg | 2 | 143 | |
| other | Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Atorvastatin 40 mg | 4 | 71 | |
| serious | Acute coronary syndrome | Cardiac disorders | Pitavastatin 4 mg | 1 | 143 | |
| serious | Acute coronary syndrome | Cardiac disorders | Atorvastatin 40 mg | 1 | 71 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pitavastatin 4 mg | ||
| Total, all-cause mortality | Atorvastatin 40 mg | ||
| Total, other adverse events | Pitavastatin 4 mg | 22 | 143 |
| Total, other adverse events | Atorvastatin 40 mg | 15 | 71 |
| Total, serious adverse events | Pitavastatin 4 mg | 8 | 143 |
| Total, serious adverse events | Atorvastatin 40 mg | 5 | 71 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pitavastatin 4 mg vs Atorvastatin 40 mg: NCEP LDL-C Target Attainment | Trial comparisons |
| Pitavastatin 4 mg vs Atorvastatin 40 mg: serious adverse events | 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/NCT00344370
GET https://conductscience.org/api/trials/v1/NCT00344370/events?page=2