A Phase 4 interventional study of pitavastatin and pravastatin in Primary Dyslipidemia and Mixed Dyslipidemia, sponsored by Kowa Research Institute, Inc.. Completed at 44 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-05-08.
Sponsored by Kowa Research Institute, Inc. · Phase 4, Interventional, and Treatment
Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's enrollment of 328 is above the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Kowa Research Institute, Inc. is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 9 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: pitavastatin
Drug: pravastatin
pitavastatin 4 mg once daily (QD)
Also known as: Livalo
Pravastatin 40 mg once daily (QD)
Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12
Time frame: Baseline and 12 weeks
| Milestone | Pitavastatin 4 mg Once a Day (QD) | Pravastatin 40 mg Once a Day (QD) |
|---|---|---|
| Started | 164 | 164 |
| Completed | 158 | 157 |
| Not completed | 6 | 7 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Persistent alt or ast elevation | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Subject non-compliance | 0 | 1 |
| Withdrew: Ldl-c elevation exceeding 250 mg/dl | 0 | 1 |
| percent | Pitavastatin 4 mg Once Daily (QD) | Pravastatin 40 mg Once Daily (QD) |
|---|---|---|
| Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 | -34.8 ± 1.20 | -22.7 ± 1.22 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pitavastatin 4 mg Once a Day (QD) | — | 2/164 (1.2%) | 19/164 (11.6%) |
| Pravastatin 40 mg Once a Day (QD) | — | 1/164 (0.6%) | 14/164 (8.5%) |
| Event | Pitavastatin 4 mg Once a Day (QD) | Pravastatin 40 mg Once a Day (QD) |
|---|---|---|
| appendicitis perforatedGastrointestinal disorders | 1/164 | 0/164 |
| prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/164 | 0/164 |
| lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 0/164 | 1/164 |
| Event | Pitavastatin 4 mg Once a Day (QD) | Pravastatin 40 mg Once a Day (QD) |
|---|---|---|
| NasopharyngitisInfections and infestations | 11/164 | 5/164 |
| upper respiratory tract infectionInfections and infestations | 8/164 | 9/164 |
| Age, Categorical(Participants) | Pitavastatin 4 mg Once a Day (QD) | Pravastatin 40 mg Once a Day (QD) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 122 | 127 | 249 |
| >=65 years | 42 | 37 | 79 |
| Age Continuous(years) | Pitavastatin 4 mg Once a Day (QD) | Pravastatin 40 mg Once a Day (QD) | Total |
|---|---|---|---|
| Mean | 58.8 ± 8.93 | 57.0 ± 10.23 | 57.9 ± 9.63 |
| Sex: Female, Male(Participants) | Pitavastatin 4 mg Once a Day (QD) | Pravastatin 40 mg Once a Day (QD) | Total |
|---|---|---|---|
| Female | 83 | 79 | 162 |
| Male | 81 | 85 | 166 |
| Region of Enrollment(participants) | Pitavastatin 4 mg Once a Day (QD) | Pravastatin 40 mg Once a Day (QD) | Total |
|---|---|---|---|
| United States | 164 | 164 | 328 |
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Kowa Research Institute, Inc.