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Simvastatin

Phase 3

Hypertriglyceridemia | Small molecule | Metabolic |GSK plc|Last Updated: Oct 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment444

FDA Designations

No designations recorded

Clinical trial landscape

Simvastatin · 5 trials · 3 indications

Phase 3 2Phase 1 3
NCT00903409Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic SubjectsHypertriglyceridemia
COMPLETED188 Analytics
NCT00246701Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic SubjectsHypertriglyceridemia
COMPLETED256 Analytics
PHASE3COMPLETED
Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
Hypertriglyceridemia
NCT00903409188
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PHASE3COMPLETED
Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
Hypertriglyceridemia
NCT00246701256
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Study Endpoints

Primary Endpoints

Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818)
Month 4 (LOV111818)

Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial)

Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in non-high-density lipoprotein cholesterol
8 weeks
The effect of albiglutide on the pharmacokinetics of simvastatin
42 days
AUC(0-inf) and Cmax of rosuvastatin alone and in the presence of GSK1292263
Day 3 and Day 12
AUC(0-inf) and Cmax of simvastatin/simvastatin acid alone and in the presence of GSK1292263
Day 1 and Day 10
Safety and tolerability evaluated by adverse event monitoring, ECG, Vital Signs, physical examination, laboratory values and Romberg/heel to toe tests; plasma analysis of Simvastatin and Atorvastatin and active metabolites.
screening period of 28 days followed 17 days clinical duration plus a follow up visit 7-14 days post last dose

Secondary Endpoints

Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in "Switchers" vs. Non-switchers
Months 4, 12, and 24 (LOV111818) of the open-label extension trial
Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial
LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial
OM6/LOV111858 - Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in other lipid and biomarker levels
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Simvastatin + Lovaza® ("Non-switchers")EXPERIMENTALOpen label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + Lovaza® in the double-blind trial, hence in this open-label extension, they are termed "Non-switchers"
Simvastatin + Lovaza® ("Switchers")EXPERIMENTALOpen label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + placebo in the double-blind trial, hence in this open-label extension, they are termed "Switchers"
SimvastatinACTIVE_COMPARATORSimvastatin + placebo
Simvastatin + LovazaEXPERIMENTALSimvastatin + Lovaza (omega-3-acid ethyl esters)
simvastatin plus albiglutideEXPERIMENTALA single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38.
Single SequenceEXPERIMENTALSimvastatin will be administered on Day 1 and Day 10. Rosuvastatin will be administered on Day 3 and Day 12. GSK1292263 will be administered on Days 6 to 14.
Cohort 1: AtorvastatinEXPERIMENTALsingle dose session with Atorvastatin with PK samples collected up to 72h post dose, then 14 days repeat dose session with SB649868 with Atorvastatin single dose co-administered on day 8 (same time as SB649868) and on day 12 (2 hours before SB649868).
Cohort 2: SimvastatinEXPERIMENTALsingle dose session with Simvastatin with PK samples collected up to 24h post dose, then 14 days repeat dose session with SB649868 with Simvastatin single dose co-administered on day 12 (same time as SB649868) and on day 14 (2 hours before SB649868).

Interventions

NameTypeDescription
Simvastatin + Lovaza® (omega-3-acid ethyl esters)DRUGOpen-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor\]
SimvastatinDRUGSimvastatin
Simvastatin + LovazaDRUGSimvastatin + Lovaza (omega-3-acid ethyl esters)
simvastatin plus albiglutideBIOLOGICALA single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38.
RosuvastatinDRUGRosuvastatin 10mg (single dose) on Days 3 and 12.
GSK1292263DRUGGSK1292263 300mg BID Days 6 to 14.
AtorvastatinDRUG20mg single dose given alone and coadministered with SB649868 on day 8 and 12 of the 14-day repeat dose period.
SB649868DRUG20mg daily given for 14 days.
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Eligibility Criteria

Age Range18 Years to 79 Years
SexALL
Healthy VolunteersNo
Study Sites40

For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8. FYI - entry criteria for LOV111818/OM6 (double-blind study) Inclusion Criteri...

Countries:United StatesGermany
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