Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2013-07-26FDA Approved: QUESTRAN — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for QUESTRAN (cholestyramine) from Endo USA, Inc., updating its labeling to reflect additional indic…
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FDA approval · 2013-07-26FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Quallent)
FDA approved a supplemental application for Pravastatin Sodium submitted by Quallent.
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CLINICAL_TRIALS trial_result · 2013-07-10Clinical Trial Update: A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1) [Phase 3]
A Phase 3 trial evaluating the effectiveness of ezetimibe/atorvastatin 10 mg/40 mg combination versus separate ezetimibe 10 mg and atorvasta…
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CLINICAL_TRIALS trial_result · 2013-07-03Clinical Trial Update: Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol [Phase 4]
This Phase 4 trial compared splitting Vytorin 10/80 into four tablets versus taking Simvastatin 20 mg for lowering LDL cholesterol in people…
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CLINICAL_TRIALS trial_result · 2013-06-28Clinical Trial Update: Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects [Phase 1]
Phase 1 trial update evaluating injection site tolerability, safety, pharmacokinetics and pharmacodynamics of different single-dose regimens…
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CLINICAL_TRIALS trial_result · 2013-06-28Clinical Trial Update: Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects [Phase 1]
Phase 1 pharmacokinetic and tolerability study of alirocumab in patients with hepatic impairment and in healthy subjects has completed. The …
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CLINICAL_TRIALS trial_result · 2013-06-28Clinical Trial Update: Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727) [Phase 1]
Phase 1 study evaluating injection site tolerability, safety, and pharmacokinetics/pharmacodynamics after a single subcutaneous dose of alir…
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CLINICAL_TRIALS trial_result · 2013-06-28Clinical Trial Update: Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727) [Phase 1]
A Phase 1 study assessed tolerability, safety, pharmacokinetics and pharmacodynamics of Alirocumab (REGN727/SAR236553) in hypercholesterolem…
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CLINICAL_TRIALS trial_result · 2013-06-20Clinical Trial Update: Lipid-lowering Effect of Plant Stanol Yogurt [NA]
Completed clinical trial evaluating the lipid-lowering effect of plant stanol yogurt sponsored by Raisio Group.
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EMA withdrawal · 2013-06-17EMA Refused: Kynamro (mipomersen sodium) — Genzyme Europe BV
The EMA refused approval for Kynamro (mipomersen sodium) by Genzyme Europe BV for hypercholesterolemia.
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CLINICAL_TRIALS trial_result · 2013-06-14Clinical Trial Update: Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe) [NA]
A completed clinical trial evaluated LDL cholesterol changes when patients with hypercholesterolemia were switched from 10 mg to 5 mg of Zet…
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CLINICAL_TRIALS trial_result · 2013-05-30Clinical Trial Update: Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522) [Phase 3]
Phase 3 pediatric trial evaluating ezetimibe monotherapy for primary hypercholesterolemia has completed. Results were posted in 2013.
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CLINICAL_TRIALS trial_result · 2013-05-30Clinical Trial Update: Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Clinical trial update for Amlodipine/Atorvastatin (Caduet) under regulatory post-marketing commitments; study completed with results posted …
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CLINICAL_TRIALS trial_result · 2013-05-20Clinical Trial Update: Low Carbohydrate Portfolio or "Eco-Atkins" Diet [Phase 2]
Phase 2 trial evaluating a low-carbohydrate diet called Eco-Atkins for hypercholesterolemia and cardiovascular disease has completed.
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CLINICAL_TRIALS trial_result · 2013-05-17Clinical Trial Update: Supplementation of Land-based Stearidonic Acid (SDA)-Rich Oils in Humans [EARLY_Phase 1]
An early-phase 1 trial evaluated supplementation with land-based stearidonic acid (SDA)-rich oils in adults with hypercholesterolemia or ove…
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CLINICAL_TRIALS trial_result · 2013-05-14Clinical Trial Update: Gut Flora and Lipid Metabolism [NA]
Clinical trial examining the relationship between gut microbiota and lipid metabolism in hypercholesterolemia has completed.
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CLINICAL_TRIALS trial_result · 2013-05-08Clinical Trial Update: Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia [Phase 4]
Phase 4 clinical trial update for BIO-25 probiotic as a supplement to statins in hypercholesterolemia; current status is unknown.
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CLINICAL_TRIALS trial_result · 2013-04-24Clinical Trial Update: Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol [Phase 2]
A Phase 2 pharmacodynamic study evaluating a cardiovascular polypill’s effect on LDL cholesterol has been terminated.
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FDA approval · 2013-04-22FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc.
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FDA approval · 2013-04-18FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for Pravastatin Sodium from Lupin Pharmaceuticals (ANDA 077917), formalizing approval of this generi…
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CLINICAL_TRIALS trial_result · 2013-04-09Clinical Trial Update: A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1) [NA]
This completed clinical trial evaluated fasting and postprandial ApoB-48 levels in diabetic participants with normal to moderately high LDL-…
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CLINICAL_TRIALS trial_result · 2013-04-05Clinical Trial Update: Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects [Phase 2]
Phase 2 safety and efficacy results for mipomersen in high-risk statin-intolerant patients. Results were posted in 2013.
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CLINICAL_TRIALS trial_result · 2013-04-02Clinical Trial Update: Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients [Phase 1, Phase 2]
A Phase 1/Phase 2 study of the experimental compound DITPA was terminated in adults with hypercholesterolemia.
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CLINICAL_TRIALS withdrawal · 2013-03-22Clinical Trial Update: Garlic in Hyperlipidemia Caused by HAART [Phase 2]
This update indicates a Phase 2 trial evaluating garlic for HAART-induced hyperlipidemia in people with HIV has been withdrawn.
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CLINICAL_TRIALS trial_result · 2013-03-21Clinical Trial Update: Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis [Phase 3]
Phase 3 trial evaluating the safety and efficacy of mipomersen added to maximally tolerated lipid-lowering therapy in adults with severe hyp…