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| Name | Class |
|---|---|
| Kowa Pharmaceuticals America, Inc. | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin 4 mg QD | Experimental |
| |
| Pravastatin 40 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | Pitavastatin 4 mg QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks | 12 weeks minus baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28416195 | Derived | Aberg JA, Sponseller CA, Ward DJ, Kryzhanovski VA, Campbell SE, Thompson MA. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised, double-blind, superiority trial. Lancet HIV. 2017 Jul;4(7):e284-e294. doi: 10.1016/S2352-3018(17)30075-9. Epub 2017 Apr 13. | |
| 28252528 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin 4 mg QD | Pitavastatin: Pitavastatin 4 mg QD |
| FG001 | Pravastatin 40 mg QD | Pravastatin: Pravastatin 40 mg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pravastatin | Drug | Pravastatin 40 mg QD |
|
| Beverly Hills |
| California |
| United States |
| Costa Mesa | California | United States |
| Long Beach | California | United States |
| Los Angeles | California | United States |
| Newport Beach | California | United States |
| San Francisco | California | United States |
| Washington D.C. | District of Columbia | United States |
| Coral Gables | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Ft. Pierce | Florida | United States |
| Miami | Florida | United States |
| Miami Beach | Florida | United States |
| Tampa | Florida | United States |
| Vero Beach | Florida | United States |
| Atlanta | Georgia | United States |
| Decatur | Georgia | United States |
| Springfield | Massachusetts | United States |
| Berkley | Michigan | United States |
| St Louis | Missouri | United States |
| Hillsborough | New Jersey | United States |
| Randolph Township | New Jersey | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Huntersville | North Carolina | United States |
| Addison | Texas | United States |
| Austin | Texas | United States |
| Corpus Christi | Texas | United States |
| Fort Worth | Texas | United States |
| Harlingen | Texas | United States |
| Houston | Texas | United States |
| Longview | Texas | United States |
| Annandale | Virginia | United States |
| Seattle | Washington | United States |
| Spokane | Washington | United States |
| Toribio M, Fitch KV, Sanchez L, Burdo TH, Williams KC, Sponseller CA, McCurdy Pate M, Aberg JA, Zanni MV, Grinspoon SK. Effects of pitavastatin and pravastatin on markers of immune activation and arterial inflammation in HIV. AIDS. 2017 Mar 27;31(6):797-806. doi: 10.1097/QAD.0000000000001427. |
| 28121706 | Derived | Joshi PH, Miller PE, Martin SS, Jones SR, Massaro JM, D'Agostino RB Sr, Kulkarni KR, Sponseller C, Toth PP. Greater remnant lipoprotein cholesterol reduction with pitavastatin compared with pravastatin in HIV-infected patients. AIDS. 2017 Apr 24;31(7):965-971. doi: 10.1097/QAD.0000000000001423. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin 4 mg QD | Pitavastatin: Pitavastatin 4 mg QD |
| BG001 | Pravastatin 40 mg QD | Pravastatin: Pravastatin 40 mg 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 |
| ||||||||||||||||||
| 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 | Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks | modified Intent To Treat (mITT) population included all randomized subjects who received at least 1 dose of study drug and had at least 1 on-treatment lipid assessment | Posted | Mean | Standard Deviation | mg/dL | 12 weeks minus baseline |
|
|
|
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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 QD | Pitavastatin: Pitavastatin 4 mg QD | 7 | 126 | 10 | 126 | ||
| EG001 | Pravastatin 40 mg QD | Pravastatin: Pravastatin 40 mg QD | 3 | 126 | 5 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
| |||
| Arteriosclerosis coronary artery | Cardiac disorders |
| |||
| Atrial septal defect | Cardiac disorders |
| |||
| Cerebrovascular accident | Nervous system disorders |
| |||
| Chest pain | Cardiac disorders |
| |||
| Diverticulitis | Gastrointestinal disorders |
| |||
| Enterovesical fistula | Gastrointestinal disorders |
| |||
| Gastroenteritis | Gastrointestinal disorders |
| |||
| Gastroenteritis viral | Gastrointestinal disorders |
| |||
| Herpes dermatitis | Infections and infestations |
| |||
| Multiple fractures | Musculoskeletal and connective tissue disorders |
| |||
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders |
| |||
| Myocardial infarction | Cardiac disorders |
| |||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders |
| |||
| Transient ischaemic attack | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders |
| |||
| Headache | General disorders |
| |||
| Upper abdominal pain | Gastrointestinal disorders |
| |||
| Blood CK increased | Blood and lymphatic system disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
|
Sponsor shall have the right to the first publication of the results of the Study. PI may publish, however PI must submit publication to sponsor for review at least 60 days prior to proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Morgan, MD, FACS | Kowa Research Institute, Inc. | 919-433-1600 | RMorgan@kowaus.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
|