A Phase 3 interventional study of Pitavastatin in Hypercholesterolemia and Dyslipidemias, sponsored by Kowa Research Europe. Completed at 59 sites in 5 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2010-03-16.
Sponsored by Kowa Research Europe · Phase 3, Interventional, and Treatment
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 545 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Kowa Research Europe is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pitavastatin 2 mg once daily
Drug: Pitavastatin
Pitavastatin 4 mg once daily
Drug: Pitavastatin
Change From Baseline in LDL-C
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Time frame: Baseline to 60 weeks
Change From Baseline in Total Cholesterol
Percent change from baseline in total cholesterol (TC)
Time frame: Baseline to 60 weeks
| Milestone | Pitavastatin 2 mg QD | Pitavastatin 4 mg QD |
|---|---|---|
| Started | 449 | 90 |
| Completed | 378 | 77 |
| Not completed | 71 | 13 |
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
| percent change | Pitavastatin 2 mg QD | Pitavastatin 4 mg QD |
|---|---|---|
| Change From Baseline in LDL-C | -43.18 ± 10.065 | -44.26 ± 10.764 |
Percent change from baseline in total cholesterol (TC)
| percent change | Pitavastatin 2 mg QD | Pitavastatin 4 mg QD |
|---|---|---|
| Change From Baseline in Total Cholesterol | -28.27 ± 8.214 | -30.54 ± 8.226 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pitavastatin 2 mg QD | — | 51/449 (11.4%) | — |
| Pitavastatin 4 mg QD | — | 7/90 (7.8%) | — |
| Event | Pitavastatin 2 mg QD | Pitavastatin 4 mg QD |
|---|---|---|
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 6/449 | 0/90 |
| Aortic valve incompetenceCardiac disorders | 0/449 | 1/90 |
| Cporonary artery occlusionCardiac disorders | 0/449 | 1/90 |
| Retinal detachmentEye disorders | 0/449 | 1/90 |
| Urinary tract infectionInfections and infestations | 0/449 | 1/90 |
| Femoral neck fractureInjury, poisoning and procedural complications | 0/449 | 1/90 |
| Cerebrovascular accidentNervous system disorders | 1/449 | 1/90 |
| Peripheral vascular disorderVascular disorders | 0/449 | 1/90 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 4/449 | 0/90 |
| Angina pectorisCardiac disorders | 2/449 | 0/90 |
| Event | Pitavastatin 2 mg QD | Pitavastatin 4 mg QD |
|---|---|---|
| NasopharyngitisInfections and infestations | 71/539 | 2/95 |
| MyalgiaMusculoskeletal and connective tissue disorders | 44/539 | 4/95 |
| HypertensionVascular disorders | 35/539 | 4/95 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 34/539 | 3/95 |
| OsteaoarthritisMusculoskeletal and connective tissue disorders | 24/539 | 5/95 |
| Urinary tract infectionInfections and infestations | 26/539 | 4/95 |
| CystitisInfections and infestations | 26/539 | 1/95 |
| CoughRespiratory, thoracic and mediastinal disorders | 26/539 | 1/95 |
| Age, Categorical(Participants) | Safety Population |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 539 |
| Age Continuous(years) | Safety Population |
|---|---|
| Mean | 70.3 ± 4.73 |
| Sex: Female, Male(Participants) | Safety Population |
|---|---|
| Female | 294 |
| Male | 245 |
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Kowa Research Europe