Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Praluent on Neurocognitive Function in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk
| Verified date | April 2021 |
| Source | Regeneron Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.
| Status | Completed |
| Enrollment | 2176 |
| Est. completion date | March 5, 2020 |
| Est. primary completion date | March 5, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 85 Years |
| Eligibility | Key Inclusion Criteria: - Men and women = age 40 years and = age 85 years - Patients with heterozygous familial hypercholesterolemia (heFH) or with non-familial hypercholesterolemia (non-FH) patients at high or very high cardiovascular risk - Patients with history of coronary heart disease (CHD) not having adequate control of their hypercholesterolemia with LDL-C =70 mg/dL, or all other patients with LDL-C =100 mg/dL and be on maximally-tolerated dose of statin (unless they are statin-intolerant) - Patients must have successfully completed the Motor Screening Task - Patients must be willing and able to comply with clinic visits and study related procedures - Patients must provide signed informed consent Key Exclusion Criteria: - Patients with known Alzheimer's disease or other dementia, schizophrenia, bipolar disorder, severe depression, cognitive impairment, or patients with a sleep disorder requiring daily pharmacological treatment - Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease - Certain laboratory findings obtained during the screening visit as defined in the protocol - Any condition or situation, including other significant mental or neurological disorders that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's participation in the study - Pregnant or breastfeeding women - A positive human immunodeficiency virus (HIV) test NOTE: Other protocol defined Inclusion/Exclusion Criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Regeneron Study Site | Pleven | |
| Bulgaria | Regeneron Study Site | Plovdiv | |
| Bulgaria | Regeneron Study Site | Plovdiv | |
| Bulgaria | Regeneron Study Site | Sofia | |
| Bulgaria | Regeneron Study Site | Sofia | |
| Bulgaria | Regeneron Study Site | Sofia | |
| Bulgaria | Regeneron Study Site | Stara Zagora | |
| Bulgaria | Regeneron Study Site 1 | Varna | |
| Bulgaria | Regeneron Study Site 2 | Varna | |
| Chile | Regeneron Study Site | Osorno | |
| Chile | Regeneron Study Site | San Miguel | |
| Chile | Regeneron Study Site | Santiago | |
| Chile | Regeneron Study Site | Santiago | |
| Chile | Regeneron Study Site | Santiago | |
| Chile | Regeneron Study Site | Santiago | |
| Chile | Regeneron Study Site | Temuco | |
| Chile | Regeneron Study Site | Temuco | |
| Chile | Regeneron Study Site | Viña del Mar | |
| Estonia | Regeneron Study Site | Paide | |
| Estonia | Regeneron Study Site | Tallinn | |
| Estonia | Regeneron Study Site | Tallinn | |
| Estonia | Regeneron Study Site | Tallinn | |
| Estonia | Regeneron Study Site | Tallinn | |
| Estonia | Regeneron Study Site 1 | Tallinn | |
| Estonia | Regeneron Study Site 2 | Tallinn | |
| Estonia | Regeneron Study Site | Tartu | |
| Japan | Regeneron Study Site | Bunkyo-Ku | Tokyo |
| Japan | Regeneron Study Site | Chuo Ku | Tokyo |
| Japan | Regeneron Study Site | Hachioji | Tokyo |
| Japan | Regeneron Study Site | Iruma-gun | Saitama |
| Japan | Regeneron Study Site | Itabashi-ku | Tokyo |
| Japan | Regeneron Study Site | Kahoku-gun | Ishikawa |
| Japan | Regeneron Study Site | Kawasaki | Kanagawa |
| Japan | Regeneron Study Site | Nakagami-gun | Okinawa |
| Japan | Regeneron Study Site | Nishinomiya | Hogo |
| Japan | Regeneron Study Site | Shinagawa-Ku | Tokyo |
| Japan | Regeneron Study Site | Uji-shi | Kyoto |
| Japan | Regeneron Study Site | Yokohama | Kanagawa |
| Mexico | Regeneron Study Site | Aguascalientes | |
| Mexico | Regeneron Study Site | Cuernavaca | |
| Mexico | Regeneron Study Site | Culiacán | |
| Mexico | Regeneron Study Site | Distrito Federal | |
| Mexico | Regeneron Study Site | Durango | |
| Mexico | Regeneron Study Site | Guadalajara | |
| Mexico | Regeneron Study Site | Guadalajara | |
| Mexico | Regeneron Study Site | Guadalajara | |
| Mexico | Regeneron Study Site | Merida | |
| Mexico | Regeneron Study Site | Mexico City | |
| Mexico | Regeneron Study Site | Mexico City | |
| Mexico | Regeneron Study Site | Mexico City | |
| Mexico | Regeneron Study Site | Monterrey | |
| Mexico | Regeneron Study Site 1 | Monterrey | |
| Mexico | Regeneron Study Site 2 | Monterrey | |
| Mexico | Regeneron Study Site | Pachuca | |
| Mexico | Regeneron Study Site | Querétaro | |
| Mexico | Regeneron Study Site | San Juan Del Río | |
| Mexico | Regeneron Study Site | Torreon | |
| Russian Federation | Regeneron Study Site | Ivanovo | |
| Russian Federation | Regeneron Study Site | Kirov | |
| Russian Federation | Regeneron Study Site | Moscow | |
| Russian Federation | Regeneron Study Site | Moscow | |
| Russian Federation | Regeneron Study Site | Moscow | |
| Russian Federation | Regeneron Study Site | Novosibirsk | |
| Russian Federation | Regeneron Study Site | Rostov-on-Don | |
| Russian Federation | Regeneron Study Site | Saint Petersburg | |
| Russian Federation | Regeneron Study Site | Saint Petersburg | |
| Russian Federation | Regeneron Study Site | Saint Petersburg | |
| Russian Federation | Regeneron Study Site | Saint Petersburg | |
| Russian Federation | Regeneron Study Site | Saint Petersburg | |
| Russian Federation | Regeneron Study Site | Saint Petersburg | |
| Russian Federation | Regeneron Study Site | Saint Petersburg | |
| Russian Federation | Regeneron Study Site | Saint Petersburg | |
| Russian Federation | Regeneron Study Site | Saratov | |
| Russian Federation | Regeneron Study Site | Tyumen' | |
| Russian Federation | Regeneron Study Site | Yaroslavl | |
| Russian Federation | Regeneron Study Site | Yaroslavl | |
| Russian Federation | Regeneron Study Site 1 | Yaroslavl | |
| Russian Federation | Regeneron Study Site 2 | Yaroslavl | |
| South Africa | Regeneron Study Site 1 | Bloemfontein | |
| South Africa | Regeneron Study Site 2 | Bloemfontein | |
| South Africa | Regeneron Study Site | Cape Town | Western Cape |
| South Africa | Regeneron Study Site | Cape Town | Western Cape |
| South Africa | Regeneron Study Site | Claremont | |
| South Africa | Regeneron Study Site | Halfway House | Gauteng |
| South Africa | Regeneron Study Site | Kempton Park | Johannesburg |
| South Africa | Regeneron Study Site | Kuils River | Cape Town |
| South Africa | Regeneron Study Site | Middelburg | Mpumalanga |
| South Africa | Regeneron Study Site | Paarl | Western Cape |
| South Africa | Regeneron Study Site | Port Elizabeth | Eastern Cape |
| South Africa | Regeneron Study Site | Pretoria | Gauteng |
| South Africa | Regeneron Study Site | Pretoria | Gauteng |
| South Africa | Regeneron Study Site | Pretoria West | Gauteng |
| South Africa | Regeneron Study Site | Somerset West | Western Cape |
| South Africa | Regeneron Study Site | Soweto | Johannesburg |
| South Africa | Regeneron Study Site | Soweto | Johannesburg |
| South Africa | Regeneron Study Site | Worcester | Western Cape |
| Ukraine | Regeneron Study Site | Kharkiv | |
| Ukraine | Regeneron Study Site | Kharkiv | |
| Ukraine | Regeneron Study Site | Kharkov | |
| Ukraine | Regeneron Study Site 1 | Kiev | |
| Ukraine | Regeneron Study Site 2 | Kiev | |
| Ukraine | Regeneron Study Site | Kyiv | |
| Ukraine | Regeneron Study Site | Kyiv | |
| Ukraine | Regeneron Study Site | Kyiv | |
| Ukraine | Regeneron Study Site | Kyiv | |
| Ukraine | Regeneron Study Site 1 | Kyiv | |
| Ukraine | Regeneron Study Site 1 | Kyiv | |
| Ukraine | Regeneron Study Site 1 | Kyiv | |
| Ukraine | Regeneron Study Site 2 | Kyiv | |
| Ukraine | Regeneron Study Site 2 | Kyiv | |
| Ukraine | Regeneron Study Site 2 | Kyiv | |
| Ukraine | Regeneron Study Site | L'viv | |
| Ukraine | Regeneron Study Site | Úzhgorod | Transcarpathian Region |
| Ukraine | Regeneron Study Site | Vinnitsa | |
| Ukraine | Regeneron Study Site 1 | Vinnitsa | |
| Ukraine | Regeneron Study Site 2 | Vinnitsa | |
| United States | Regeneron Study Site | Ames | Iowa |
| United States | Regeneron Study Site | Auburn | Alabama |
| United States | Regeneron Study Site 1 | Aurora | Colorado |
| United States | Regeneron Study Site 2 | Aurora | Colorado |
| United States | Regeneron Study Site | Baltimore | Maryland |
| United States | Regeneron Study Site | Bangor | Maine |
| United States | Regeneron Study Site | Beverly Hills | California |
| United States | Regeneron Study Site | Birmingham | Alabama |
| United States | Regeneron Study Site | Bristol | Tennessee |
| United States | Regeneron Study Site | Buffalo | New York |
| United States | Regeneron Study Site | Burien | Washington |
| United States | Regeneron Study Site | Cary | North Carolina |
| United States | Regeneron Study Site | Champaign | Illinois |
| United States | Regeneron Study Site | Charleston | South Carolina |
| United States | Regeneron Study Site | Charlotte | North Carolina |
| United States | Regeneron Study Site | Charlotte | North Carolina |
| United States | Regeneron Study Site | Chicago | Illinois |
| United States | Regeneron Study Site | Chicago | Illinois |
| United States | Regeneron Study Site | Cincinnati | Ohio |
| United States | Regeneron Study Site | Cleveland | Ohio |
| United States | Regeneron Study Site | Colorado Springs | Colorado |
| United States | Regeneron Study Site | Covington | Georgia |
| United States | Regeneron Study Site | Dallas | Texas |
| United States | Regeneron Study Site | Dayton | Ohio |
| United States | Regeneron Study Site | Duncansville | Pennsylvania |
| United States | Regeneron Study Site | Evansville | Indiana |
| United States | Regeneron Study Site | Everett | Washington |
| United States | Regeneron Study Site | Falls Church | Virginia |
| United States | Regeneron Study Site | Greensboro | North Carolina |
| United States | Regeneron Study Site | Greenville | South Carolina |
| United States | Regeneron Study Site | Hickory | North Carolina |
| United States | Regeneron Study Site | High Point | North Carolina |
| United States | Regeneron Study Site | Houston | Texas |
| United States | Regeneron Study Site | Houston | Texas |
| United States | Regeneron Study Site | Hutchinson | Kansas |
| United States | Regeneron Study Site | Indianapolis | Indiana |
| United States | Regeneron Study Site | Iowa City | Iowa |
| United States | Regeneron Study Site | Knoxville | Tennessee |
| United States | Regeneron Study Site | Knoxville | Tennessee |
| United States | Regeneron Study Site | Knoxville | Tennessee |
| United States | Regeneron Study Site | Lake Worth | Florida |
| United States | Regeneron Study Site | Lake Worth | Florida |
| United States | Regeneron Study Site | Los Gatos | California |
| United States | Regeneron Study Site | Louisville | Kentucky |
| United States | Regeneron Study Site | Manitowoc | Wisconsin |
| United States | Regeneron Study Site | Miami Springs | Florida |
| United States | Regeneron Study Site | Minneapolis | Minnesota |
| United States | Regeneron Study Site | Mobile | Alabama |
| United States | Regeneron Study Site | New Hyde Park | New York |
| United States | Regeneron Study Site | Newton | Kansas |
| United States | Regeneron Study Site | North Hollywood | California |
| United States | Regeneron Study Site | Olive Branch | Mississippi |
| United States | Regeneron Study Site | Overland Park | Kansas |
| United States | Regeneron Study Site | Oxon Hill | Maryland |
| United States | Regeneron Study Site | Port Hueneme | California |
| United States | Regeneron Study Site | Powell | Tennessee |
| United States | Regeneron Study Site | Raleigh | North Carolina |
| United States | Regeneron Study Site | Rapid City | South Dakota |
| United States | Regeneron Study Site | Rock Island | Illinois |
| United States | Regeneron Study Site | Rocky Mount | North Carolina |
| United States | Regeneron Study Site | Salisbury | North Carolina |
| United States | Regeneron Study Site | Schertz | Texas |
| United States | Regeneron Study Site | Shavano Park | Texas |
| United States | Regeneron Study Site | Statesville | North Carolina |
| United States | Regeneron Study Site | Summerville | South Carolina |
| United States | Regeneron Study Site | Tacoma | Washington |
| United States | Regeneron Study Site | Walla Walla | Washington |
| United States | Regeneron Study Site | Washington | Missouri |
| United States | Regeneron Study Site | Waterloo | Iowa |
| United States | Regeneron Study Site | Westminster | California |
| United States | Regeneron Study Site | Wilmington | North Carolina |
| United States | Regeneron Study Site | Winchester | Virginia |
| United States | Regeneron Study Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Regeneron Pharmaceuticals | Sanofi |
United States, Bulgaria, Chile, Estonia, Japan, Mexico, Russian Federation, South Africa, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96 | CANTAB SWM task assessed cognitive domain of executive function. Colored boxes were shown on a screen. A token was hidden in one of the boxes (never same box twice). Instructions were to touch boxes to search for token until number of tokens found equaled number of boxes. SWM strategy index represents number of times a search began with a different box. Z-score represents standardized measure of how far an individual deviated from study cohort average at baseline. A higher Z-score reflects better performance. | Week 96 | |
| Secondary | Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96 | CANTAB SWM task assessed cognitive domain of executive function. Colored boxes were shown on a screen. A token was hidden in one of the boxes (never same box twice). Instructions were to touch boxes to search for token until number of tokens found equaled number of boxes. SWM strategy index represents number of times a search began with a different box. Lower change from baseline raw scores reflect better SWM performance (i.e. less impairment). | Week 96 | |
| Secondary | Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 | Percent change from baseline in calculated LDL-C at Week 12, 24, 48, 72, and 96 was reported. LDL-C was measured using conventional units milligram per deciliter (mg/dL). | Week 12, 24, 48, 72, and 96 | |
| Secondary | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96 | Percent change from baseline in Apo B at Week 12, 24, 48, 72, and 96 was reported. Apo B was measured using conventional units mg/dL. | Week 12, 24, 48, 72, and 96 | |
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96 | Percent change from baseline in non-HDL-C at Week 12, 24, 48, 72, and 96 was reported. Non-HDL-C was measured using conventional units mg/dL. | Week 12, 24, 48, 72, and 96 | |
| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96 | Percent change from baseline in calculated Total-C at Week 12, 24, 48, 72, and 96 was reported. Total-C was measured using conventional units mg/dL. | Week 12, 24, 48, 72, and 96 | |
| Secondary | Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96 | Percent change from baseline in Lp(a) at Week 12, 24, 48, 72, and 96 was reported. Lp(a) was measured using conventional units mg/dL. | Week 12, 24, 48, 72, and 96 | |
| Secondary | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96 | Percent change from baseline in HDL-C at Week 12, 24, 48, 72, and 96 was reported. HDL-C was measured using conventional units mg/dL. | Week 12, 24, 48, 72, and 96 | |
| Secondary | Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96 | Percent change from baseline in TG at Week 12, 24, 48, 72, and 96 was reported. TG was measured using conventional units mg/dL. | Week 12, 24, 48, 72, and 96 | |
| Secondary | Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96 | Percent change from baseline in Apo A-1 at Week 12, 24, 48, 72, and 96 was reported. Apo A-1 was measured using conventional units mg/dL. | Week 12, 24, 48, 72, and 96 | |
| Secondary | Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 70 mg/dL (1.81 Millimoles Per Liter [mmol/L]) at Week 12, 24, 48, 72, and 96 | Percentage of participants who reached LDL-C level < 70 mg/dL (1.81 mmol/L) at Week 12, 24, 48, 72, and 96 were reported. | Week 12, 24, 48, 72, and 96 | |
| Secondary | Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96 | Percentage of participants who reached LDL-C level < 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96 were reported. | Week 12, 24, 48, 72, and 96 | |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | An Adverse Event (AE) was any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as AEs that developed or worsened/became serious during on-treatment period (time from the first double-blind study treatment injection up to 70 days after the last double-blind study treatment injection). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participant hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. | Up to Week 96 |
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