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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pitavastatin 4 mg once daily (QD) | Experimental |
| |
| pravastatin 40 mg once daily (QD) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pitavastatin | Drug | pitavastatin 4 mg once daily (QD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26922296 | Derived | Miller PE, Martin SS, Joshi PH, Jones SR, Massaro JM, D'Agostino RB, Sponseller CA, Toth PP. Pitavastatin 4 mg Provides Significantly Greater Reduction in Remnant Lipoprotein Cholesterol Compared With Pravastatin 40 mg: Results from the Short-term Phase IV PREVAIL US Trial in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia. Clin Ther. 2016 Mar;38(3):603-9. doi: 10.1016/j.clinthera.2016.02.001. Epub 2016 Feb 26. | |
| 24998014 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin 4 mg Once a Day (QD) | |
| FG001 | Pravastatin 40 mg Once a Day (QD) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| pravastatin | Drug | Pravastatin 40 mg once daily (QD) |
|
| Muscle Shoals |
| Alabama |
| United States |
| Chandler | Arizona | United States |
| Goodyear | Arizona | United States |
| Phoenix | Arizona | United States |
| Beverly Hills | California | United States |
| Los Angeles | California | United States |
| Newport Beach | California | United States |
| Colorado Springs | Colorado | United States |
| Clearwater | Florida | United States |
| DeLand | Florida | United States |
| Fort Luaderdale | Florida | United States |
| Jacksonville | Florida | United States |
| Miami | Florida | United States |
| Oviedo | Florida | United States |
| Pembroke Pines | Florida | United States |
| Ponte Vedra | Florida | United States |
| Addison | Illinois | United States |
| Chicago | Illinois | United States |
| Evansville | Indiana | United States |
| Indianapolis | Indiana | United States |
| Kansas City | Kansas | United States |
| Erlanger | Kentucky | United States |
| Baltimore | Maryland | United States |
| Brockton | Massachusetts | United States |
| Edina | Minnesota | United States |
| Las Vegas | Nevada | United States |
| Berlin | New Jersey | United States |
| Rochester | New York | United States |
| Statesville | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Lyndhurst | Ohio | United States |
| Willoughby Hills | Ohio | United States |
| Tulsa | Oklahoma | United States |
| Eugene | Oregon | United States |
| Greer | South Carolina | United States |
| Mt. Pleasant | South Carolina | United States |
| Corpus Christi | Texas | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Olympia | Washington | United States |
| Derived |
| Sponseller CA, Morgan RE, Kryzhanovski VA, Campbell SE, Davidson MH. Comparison of the lipid-lowering effects of pitavastatin 4 mg versus pravastatin 40 mg in adults with primary hyperlipidemia or mixed (combined) dyslipidemia: a Phase IV, prospective, US, multicenter, randomized, double-blind, superiority trial. Clin Ther. 2014 Aug 1;36(8):1211-22. doi: 10.1016/j.clinthera.2014.06.009. Epub 2014 Jul 3. |
| 24328357 | Derived | Chapman MJ, Orsoni A, Robillard P, Hounslow N, Sponseller CA, Giral P. Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Curr Med Res Opin. 2014 May;30(5):775-84. doi: 10.1185/03007995.2013.874989. Epub 2014 Jan 10. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin 4 mg Once a Day (QD) | |
| BG001 | Pravastatin 40 mg Once a Day (QD) | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 | All randomized subjects who took at least 1 dose of double-blind study drug, had a baseline efficacy measurement, and had at least 1 valid post-baseline efficacy measurement. | Posted | Mean | Standard Error | percent | Baseline and 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pitavastatin 4 mg Once a Day (QD) | 2 | 164 | 19 | 164 | |||
| EG001 | Pravastatin 40 mg Once a Day (QD) | 1 | 164 | 14 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| appendicitis perforated | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
May not publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Morgan, MD, FACS | Kowa Research Institute, Inc. | 919-433-1600 | RMorgan@KowaUS.com |
| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| >=65 years |
|
| Male |
|