Hypercholesterolemia
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CLINICAL_TRIALS trial_result · 2024-05-16Clinical Trial Update: Effect of Serum LDL Cholesterol Concentration on Pancreatic Insulin Secretion [NA]
This clinical trial update notes termination of a study investigating the effect of serum LDL cholesterol concentration on pancreatic insuli…
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CLINICAL_TRIALS trial_result · 2024-05-10Clinical Trial Update: Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017) [Phase 3]
Phase 3 trial update reports long-term safety and tolerability of the ezetimibe and atorvastatin combination in hypercholesterolemia.
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CLINICAL_TRIALS trial_result · 2024-05-10Clinical Trial Update: MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED) [Phase 3]
Phase 3 trial comparing MK0653A (ezetimibe plus simvastatin) against atorvastatin for hypercholesterolemia has completed.
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CLINICAL_TRIALS trial_result · 2024-05-10Clinical Trial Update: Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED) [Phase 3]
Completed Phase 3 trial evaluating the addition of ezetimibe to statin therapy for hypercholesterolemia (EASY study).
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CLINICAL_TRIALS trial_result · 2024-05-10Clinical Trial Update: An Efficacy and Safety Study of Ezetimibe (MK-0653, SCH 58235) in Addition to Atorvastatin Compared to Placebo in Participants With Primary Hypercholesterolemia (MK-0653-013) [Phase 3]
Phase 3 trial evaluating ezetimibe added to atorvastatin versus placebo in adults with primary hypercholesterolemia to assess efficacy and s…
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CLINICAL_TRIALS trial_result · 2024-05-10Clinical Trial Update: A Study of SCH 58235 (Ezetimibe) When Added to Ongoing Therapy With a Statin in Participants With Primary Hypercholesterolemia, Known Coronary Heart Disease, or Multiple Cardiovascular Risk Factors (P02173) [Phase 3]
Phase 3 trial evaluating ezetimibe (SCH 58235) added to ongoing statin therapy in adults with primary hypercholesterolemia, known coronary h…
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CLINICAL_TRIALS trial_result · 2024-05-10Clinical Trial Update: Efficacy and Safety Study of Ezetimibe (SCH 58235, MK-0653) in Addition to Atorvastatin in Participants With Coronary Heart Disease or Multiple Cardiovascular Risk Factors (P00693/MK-0653-030) [Phase 3]
Phase 3 trial examining the addition of ezetimibe to atorvastatin in individuals with coronary heart disease or multiple cardiovascular risk…
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CLINICAL_TRIALS trial_result · 2024-05-08Clinical Trial Update: Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia [Phase 4]
Phase 4 trial update evaluating prescription omega-3's effect on LDL-C in primary hypercholesterolemia; results have been posted.
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CLINICAL_TRIALS research · 2024-05-08Clinical Trial Update: Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels [NA]
Clinical trial update from the University of Bologna evaluating the effects of a dietary supplement on lipid patterns, indices related to no…
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CLINICAL_TRIALS trial_result · 2024-04-30Clinical Trial Update: CoQ10 in Statin-associated Asthenia [NA]
Clinical trial evaluating Coenzyme Q10 for statin-associated asthenia in people with hypercholesterolemia; the study has completed.
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CLINICAL_TRIALS trial_result · 2024-04-26Clinical Trial Update: Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation [NA]
This clinical trial update reports the completion of a study evaluating the effect of a combined food supplement on lipid profiles, non-alco…
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CLINICAL_TRIALS trial_result · 2024-04-24Clinical Trial Update: Randomized Study of Obicetrapib in Combination With Ezetimibe [Phase 2]
Phase 2 randomized study of Obicetrapib in combination with Ezetimibe for dyslipidemias and high cholesterol has completed with results post…
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CLINICAL_TRIALS trial_result · 2024-04-11Clinical Trial Update: Effect of Pitavastatin on Bone [Phase 4]
Phase 4 trial exploring the effect of pitavastatin on bone health in patients with osteoporosis/osteopenia and hypercholesterolemia; study c…
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CLINICAL_TRIALS trial_result · 2024-04-09Clinical Trial Update: Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD） [Phase 2]
Phase 2 trial of HSK31679 in adults with hypercholesterolemia completed.
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FDA approval · 2024-03-29FDA Approved: EZETIMIBE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for ezetimibe filed by Quallent Pharmaceuticals Health LLC. This confirms approval of a new or m…
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CLINICAL_TRIALS trial_result · 2024-03-25Clinical Trial Update: Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support [Phase 3]
Novartis completed a Phase 3 trial evaluating how inclisiran is delivered in primary care with enhanced support, focusing on implementation …
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FDA approval · 2024-03-12FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA supplemental approval has been granted for rosuvastatin from Camber Pharmaceuticals, indicating an approved supplemental application for…
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CLINICAL_TRIALS trial_result · 2024-03-06Clinical Trial Update: Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C [Phase 3]
Phase 3 trial update evaluating long-term dosing of inclisiran in high cardiovascular risk patients with elevated LDL-C; study completed wit…
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CLINICAL_TRIALS trial_result · 2024-03-04Clinical Trial Update: A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia [Phase 2]
Results from a Phase 2 dose-finding trial of ETC-1002 (bempedoic acid) in adults with hypercholesterolemia have been posted, evaluating mult…
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FDA approval · 2024-02-21FDA Approved: ZETIA — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Zetia (ezetimibe) from Organon LLC.
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CLINICAL_TRIALS trial_result · 2024-02-20Clinical Trial Update: Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events
A completed clinical trial update on preventing cardiovascular events in patients with high to very high risk dyslipidemia; results posted i…
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FDA approval · 2024-02-08FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.
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FDA approval · 2024-02-02FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)
FDA approved a supplemental application for Rosuvastatin Calcium submitted by Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2024-02-02FDA Approved: EZETIMIBE — Supplemental Application (Marlex Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ezetimibe submitted by Marlex Pharmaceuticals, Inc. The action updates the approval status f…
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FDA approval · 2024-01-31FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approves a supplemental application for simvastatin from NorthStar Rx LLC (ANDA).