Sphingolipidoses News - LARVOL Sigma

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|||||||||| Trial primary completion date: Alternative Treatments for Menopausal Women (clinicaltrials.gov) - Jul 10, 2014
P=N/A, N=61, Recruiting, Sponsor: Aarhus University Hospital
Trial primary completion date: Sep 2014 --> Dec 2014

|||||||||| Trial primary completion date: Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia (clinicaltrials.gov) - Jul 8, 2014
P3, N=210, Completed, Sponsor: Yuhan Corporation
Trial primary completion date: Sep 2014 --> Dec 2014 Trial primary completion date: Feb 2015 --> Jun 2014

|||||||||| Trial completion, Trial primary completion date: Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia (clinicaltrials.gov) - Jul 8, 2014
P3, N=210, Completed, Sponsor: Yuhan Corporation
Trial primary completion date: Feb 2015 --> Jun 2014 Active, not recruiting --> Completed | Trial primary completion date: Feb 2015 --> Jun 2014

||||||||||  pradigastat (LCQ908) / Novartis
Trial completion:  A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome (clinicaltrials.gov) -  Jul 8, 2014
P3, N=45, Completed,  Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed | Trial primary completion date: Feb 2015 --> Jun 2014 Active, not recruiting --> Completed

||||||||||  Myalept (metreleptin) / Novelion
Enrollment change:  Leptin to Treat Lipodystrophy (clinicaltrials.gov) -  Jul 4, 2014
P2, N=105, Active, not recruiting,  Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Active, not recruiting --> Completed N=99999999 --> 105

|||||||||| Clinical: Egg Effects on Atherogenic Dyslipidemias, Glucose Metabolism and Inflammation in Diabetic Subjects (clinicaltrials.gov) - Jul 4, 2014
P=N/A, N=33, Completed, Sponsor: University of Connecticut

|||||||||| Enrollment open: Efficacy Study of an Online Educational Module Before Carrier Genetic Screening in Persons of Ashkenazi Jewish Descent. (clinicaltrials.gov) - Jul 4, 2014
P=N/A, N=60, Recruiting, Sponsor: McGill University Health Center
N=99999999 --> 105 Not yet recruiting --> Recruiting

||||||||||  Myalept (metreleptin) / Novelion
Enrollment closed, Enrollment change:  Leptin to Treat Lipodystrophy (clinicaltrials.gov) -  Jul 4, 2014
P2, N=105, Active, not recruiting,  Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=99999999 --> 105

|||||||||| Clinical: PRECOR-NUT: Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS (clinicaltrials.gov) - Jul 2, 2014
P=N/A, N=290, Completed, Sponsor: Conselho Nacional de Desenvolvimento Científico e Tecnológico

||||||||||  Nexletol (bempedoic acid) / Esperion Therap, Otsuka, Daiichi Sankyo
New P2 trial:  Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension (clinicaltrials.gov) -  Jul 2, 2014
P2, N=144, Recruiting,  Sponsor: Esperion Therapeutics

||||||||||  Nexletol (bempedoic acid) / Esperion Therap, Otsuka, Daiichi Sankyo
Enrollment open:  Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension (clinicaltrials.gov) -  Jul 2, 2014
P2, N=144, Recruiting,  Sponsor: Esperion Therapeutics
Recruiting --> Active, not recruiting | N=99999999 --> 105 Not yet recruiting --> Recruiting

|||||||||| Trial primary completion date: Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule (clinicaltrials.gov) - Jun 27, 2014
P2, N=150, Completed, Sponsor: Micropharma Limited
Not yet recruiting --> Recruiting Trial primary completion date: Mar 2013 --> Dec 2013

||||||||||  Galafold (migalastat) / Amicus
Trial primary completion date:  Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease (clinicaltrials.gov) -  Jun 27, 2014
P3, N=60, Active, not recruiting,  Sponsor: Amicus Therapeutics
Trial primary completion date: Mar 2013 --> Dec 2013 Trial primary completion date: Aug 2014 --> May 2014

||||||||||  anacetrapib (MK-0859) / Merck (MSD)
Trial termination:  Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042) (clinicaltrials.gov) -  Jun 27, 2014
P3, N=2, Terminated,  Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Aug 2014 --> May 2014 Active, not recruiting --> Terminated

||||||||||  anacetrapib (MK-0859) / Merck (MSD)
Enrollment change, Trial termination:  Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042) (clinicaltrials.gov) -  Jun 27, 2014
P3, N=2, Terminated,  Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Terminated N=45 --> 2 | Active, not recruiting --> Terminated

||||||||||  Galafold (migalastat) / Amicus
Enrollment change, Trial primary completion date:  Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease (clinicaltrials.gov) -  Jun 27, 2014
P3, N=60, Active, not recruiting,  Sponsor: Amicus Therapeutics
N=45 --> 2 | Active, not recruiting --> Terminated N=50 --> 60 | Trial primary completion date: Aug 2014 --> May 2014

||||||||||  Juxtapid (lomitapide) / Novelion, Chiesi
New P3 trial:  Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy (clinicaltrials.gov) -  Jun 27, 2014
P3, N=10, Recruiting,  Sponsor: Aegerion Pharmaceuticals, Inc.

||||||||||  Juxtapid (lomitapide) / Novelion, Chiesi
Enrollment open, New P3 trial:  Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy (clinicaltrials.gov) -  Jun 27, 2014
P3, N=10, Recruiting,  Sponsor: Aegerion Pharmaceuticals, Inc.
N=50 --> 60 | Trial primary completion date: Aug 2014 --> May 2014 Not yet recruiting --> Recruiting

|||||||||| Trial completion, Trial primary completion date: Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule (clinicaltrials.gov) - Jun 27, 2014
P2, N=150, Completed, Sponsor: Micropharma Limited
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial primary completion date: Mar 2013 --> Dec 2013

||||||||||  pradigastat (LCQ908) / Novartis
Trial primary completion date:  Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome. (clinicaltrials.gov) -  Jun 26, 2014
P3, N=42, Recruiting,  Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed | Trial primary completion date: Mar 2013 --> Dec 2013 Trial primary completion date: Feb 2015 --> Nov 2016

||||||||||  evacetrapib (LY2484595) / Eli Lilly
New P1 trial:  A Study of Evacetrapib in Participants With Abnormal Cholesterol (clinicaltrials.gov) -  Jun 22, 2014
P1, N=101, Recruiting,  Sponsor: Eli Lilly and Company

|||||||||| Trial primary completion date, Adherence: Improving Adherence to Statins Among Minority Populations (clinicaltrials.gov) - Jun 19, 2014
P=N/A, N=800, Recruiting, Sponsor: University of Miami
Trial primary completion date: Feb 2015 --> Nov 2016 Trial primary completion date: Dec 2014 --> Oct 2015

||||||||||  atorvastatin / Generic mfg., fenofibrate/pravastatin / Generic mfg.
New P3 trial, Monotherapy, Head-to-Head:  Clinical Trial to Evaluate the Efficacy and Safety of Pravafenix Cap to Verify the Superiority Than Atorvastatin (clinicaltrials.gov) -  Jun 19, 2014
P3, N=366, Recruiting,  Sponsor: Yooyoung Pharmaceutical Co.,Ltd.

||||||||||  Tuvero (fimasartan/rosuvastatin) / Boryung Group
New P3 trial:  A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Rosuvastatin in Comparison to Each Component Administered Alone in Patients With Essential Hypertension and Dyslipidemia (clinicaltrials.gov) -  Jun 19, 2014
P3, N=135, Not yet recruiting,  Sponsor: Boryung Pharmaceutical Co., Ltd

||||||||||  emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Trial completion, Monotherapy:  Trial To Assess The Lipid-Lowering Effect Of Adding Tenofovir/Emtricitabine Co-Formulation Vs Placebo To Hiv-1-Infected Subjects With Dyslipidemia And Sustained Viral Load Suppression Under Monotherapy With Ritonavir-Boosted Protease Inhibitors (clinicaltrials.gov) -  Jun 19, 2014
P4, N=48, Completed,  Sponsor: Fundacio Lluita Contra la SIDA
Trial primary completion date: Dec 2014 --> Oct 2015 Active, not recruiting --> Completed

||||||||||  Nexletol (bempedoic acid) / Esperion Therap, Otsuka, Daiichi Sankyo
Enrollment closed:  Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients (clinicaltrials.gov) -  Jun 19, 2014
P2, N=322, Active, not recruiting,  Sponsor: Esperion Therapeutics
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  Galafold (migalastat) / Amicus
Trial completion:  A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers (clinicaltrials.gov) -  Jun 19, 2014
P1, N=31, Completed,  Sponsor: Amicus Therapeutics
Recruiting --> Active, not recruiting Recruiting --> Completed

|||||||||| Trial primary completion date: Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease (clinicaltrials.gov) - Jun 18, 2014
P=N/A, N=120, Recruiting, Sponsor: Yale University
Recruiting --> Completed Trial primary completion date: Mar 2014 --> Mar 2018

|||||||||| Trial primary completion date: HCIT-MLD: Imaging Study of the White Matter Lesions in Children With Metachromatic Leucodystrophy (clinicaltrials.gov) - Jun 17, 2014
P=N/A, N=30, Recruiting, Sponsor: Assistance Publique - H
Trial primary completion date: Mar 2014 --> Mar 2018 Trial primary completion date: Nov 2014 --> Jan 2016

||||||||||  Zorbtive (somatropin) / EMD Serono
Trial completion:  Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients (clinicaltrials.gov) -  Jun 15, 2014
P3, N=569, Completed,  Sponsor: EMD Serono
Trial primary completion date: Nov 2014 --> Jan 2016 No longer recruiting --> Completed

|||||||||| Trial primary completion date: Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children (clinicaltrials.gov) - Jun 13, 2014
P2, N=13, Terminated, Sponsor: The Hospital for Sick Children
No longer recruiting --> Completed Trial primary completion date: Feb 2009 --> Oct 2011

|||||||||| Trial termination: Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children (clinicaltrials.gov) - Jun 13, 2014
P2, N=13, Terminated, Sponsor: The Hospital for Sick Children
Trial primary completion date: Feb 2009 --> Oct 2011 Recruiting --> Terminated; Unable to enroll sufficient patients

|||||||||| Enrollment change: Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children (clinicaltrials.gov) - Jun 13, 2014
P2, N=13, Terminated, Sponsor: The Hospital for Sick Children
Recruiting --> Terminated; Unable to enroll sufficient patients N=20 --> 13

|||||||||| Trial primary completion date: Efficacy Study of an Online Educational Module Before Carrier Genetic Screening in Persons of Ashkenazi Jewish Descent. (clinicaltrials.gov) - Jun 5, 2014
P=N/A, N=60, Not yet recruiting, Sponsor: McGill University Health Center
N=20 --> 13 Trial primary completion date: Jun 2014 --> Jun 2015

|||||||||| Trial initiation date: Efficacy Study of an Online Educational Module Before Carrier Genetic Screening in Persons of Ashkenazi Jewish Descent. (clinicaltrials.gov) - Jun 5, 2014
P=N/A, N=60, Not yet recruiting, Sponsor: McGill University Health Center
Trial primary completion date: Jun 2014 --> Jun 2015 Initiation date: Jan 2014 --> Jul 2014

||||||||||  simvastatin / Generic mfg.
Trial completion:  Simvastatin Therapy in Smith-Lemli-Opitz Syndrome (clinicaltrials.gov) -  Jun 4, 2014
P2, N=23, Completed,  Sponsor: Forbes Porter, M.D.
Initiation date: Jan 2014 --> Jul 2014 Active, not recruiting --> Completed

|||||||||| Trial primary completion date: Effects of Amino Acids on Regional Lipid Metabolism (clinicaltrials.gov) - Jun 3, 2014
P=N/A, N=125, Recruiting, Sponsor: University of Arkansas
Active, not recruiting --> Completed Trial primary completion date: Mar 2014 --> Dec 2014

||||||||||  rocacetrapib (CKD-519) / Chong Kun Dang
New P1 trial:  Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519 (clinicaltrials.gov) -  Jun 3, 2014
P1, N=40, Not yet recruiting,  Sponsor: Chong Kun Dang Pharmaceutical

|||||||||| Trial primary completion date: REDUCS: Reduction of Sweetened Beverages and Intrahepatic Fat (clinicaltrials.gov) - Jun 2, 2014
P=N/A, N=29, Completed, Sponsor: University of Lausanne
Trial primary completion date: Mar 2014 --> Dec 2014 Trial primary completion date: Aug 2013 --> Apr 2014

|||||||||| Enrollment change: REDUCS: Reduction of Sweetened Beverages and Intrahepatic Fat (clinicaltrials.gov) - Jun 2, 2014
P=N/A, N=29, Completed, Sponsor: University of Lausanne
Trial primary completion date: Aug 2013 --> Apr 2014 N=68 --> 29

|||||||||| Trial completion: REDUCS: Reduction of Sweetened Beverages and Intrahepatic Fat (clinicaltrials.gov) - Jun 2, 2014
P=N/A, N=29, Completed, Sponsor: University of Lausanne
N=68 --> 29 Recruiting --> Completed

||||||||||  fenofibrate / Generic mfg.
New P4 trial:  IISPV-HUSJR-LOWHDL: Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment (clinicaltrials.gov) -  Jun 1, 2014
P4, N=30, Completed,  Sponsor: Institut Investigacio Sanitaria Pere Virgili

||||||||||  pradigastat (LCQ908) / Novartis
Trial primary completion date:  Efficacy of LCQ908 on Cardiovascular Risk (clinicaltrials.gov) -  May 29, 2014
P2, N=78, Recruiting,  Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed Trial primary completion date: Jan 2014 --> Jun 2014

|||||||||| Clinical: Screening for Fabry Disease in a Pediatric Population at Risk (clinicaltrials.gov) - May 29, 2014
P=N/A, N=2000, Recruiting, Sponsor: University Hospital Heidelberg

||||||||||  colchicine / Generic mfg.
Trial completion date:  Apolipoprotein CIII Reduction Via Colchicine (clinicaltrials.gov) -  May 27, 2014
P0, N=5, Completed,  Sponsor: Scripps Translational Science Institute
Trial primary completion date: Jan 2014 --> Jun 2014 Trial completion date: Aug 2014 --> May 2014

||||||||||  colchicine / Generic mfg.
Enrollment change:  Apolipoprotein CIII Reduction Via Colchicine (clinicaltrials.gov) -  May 27, 2014
P0, N=5, Completed,  Sponsor: Scripps Translational Science Institute
Trial completion date: Aug 2014 --> May 2014 N=70 --> 5

||||||||||  colchicine / Generic mfg.
Trial completion:  Apolipoprotein CIII Reduction Via Colchicine (clinicaltrials.gov) -  May 27, 2014
P0, N=5, Completed,  Sponsor: Scripps Translational Science Institute
N=70 --> 5 Active, not recruiting --> Completed

||||||||||  Praluent (alirocumab) / Sanofi, Regeneron
Trial completion:  Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I) (clinicaltrials.gov) -  May 27, 2014
P3, N=306, Completed,  Sponsor: Sanofi
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  anacetrapib (MK-0859) / Merck (MSD)
Trial completion:  A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029) (clinicaltrials.gov) -  May 26, 2014
P2b, N=408, Completed,  Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  ezetimibe / Generic mfg.
Trial primary completion date:  PRECISE-IVUS: Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound (clinicaltrials.gov) -  May 26, 2014
P4, N=245, Active, not recruiting,  Sponsor: Kumamoto University
Active, not recruiting --> Completed Trial primary completion date: Dec 2013 --> Mar 2014



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