260. Sitosterolemia Clinical trials / Disease details
Clinical trials : 13 / Drugs : 13 - (DrugBank : 4) / Drug target gene : 1 - Drug target pathway : 1
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01584206 (ClinicalTrials.gov) | April 2012 | 16/4/2012 | Sitosterolemia Metabolism | Assessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With Ezetimibe | Sitosterolemia | Drug: Ezetimibe | University of Manitoba | NULL | Completed | 16 Years | 99 Years | All | 8 | N/A | Canada |
| 2 | NCT00705211 (ClinicalTrials.gov) | June 2007 | 23/6/2008 | A 52-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05245) | Designated Drug Use Investigation (Long-Term Administration) of Zetia 10-mg Tablets - A 52-Week Long-Term Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy | Hypercholesterolemia;Familial Hypercholesterolemia;Homozygous Sitosterolemia | Drug: Ezetimibe;Drug: Ezetimibe + other lipid-lowering medication(s) | Organon and Co | Bayer | Completed | N/A | N/A | All | 1794 | NULL | |
| 3 | NCT00704444 (ClinicalTrials.gov) | June 2007 | 23/6/2008 | A 12-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05244) | Designated Drug Use Investigation (12 Weeks) of Zetia 10mg Tablets - A 12-Week Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy | Hypercholesterolemia;Familial Hypercholesterolemia;Homozygous Sitosterolemia | Drug: Ezetimibe;Drug: Ezetimibe + other lipid-lowering medication(s) | Organon and Co | Bayer | Completed | N/A | N/A | All | 11332 | NULL | |
| 4 | EUCTR2004-001580-22-DE (EUCTR) | 21/12/2004 | 20/10/2004 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose Study | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose Study | Homozygous Sitosterolemia | Trade Name: Ezetrol Product Name: Ezetrol Product Code: MK-0653 | MSD SHARP & DOHME GMBH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Germany;United Kingdom | |||
| 5 | EUCTR2004-001580-22-GB (EUCTR) | 16/12/2004 | 24/02/2005 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose Study | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose Study | Homozygous Sitosterolemia | Trade Name: Ezetrol Product Name: Ezetrol Product Code: MK-0653 | Merck Sharp & Dohme Ltd | NULL | Not Recruiting | Female: yes Male: yes | 30 | Germany;United Kingdom | |||
| 6 | NCT00099996 (ClinicalTrials.gov) | December 2004 | 21/12/2004 | Higher-Dose Ezetimibe to Treat Homozygous Sitosterolemia | A Study to Assess Adding Ezetimibe 30 mg to Ongoing Treatment With Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia | Heart Diseases;Metabolism, Inborn Errors | Drug: SCH-58235;Drug: Ezetimibe | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | N/A | N/A | Both | 3 | Phase 3 | United States |
| 7 | NCT00092898 (ClinicalTrials.gov) | October 2004 | 23/9/2004 | An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to An Ongoing Regimen of Ezetimibe 10 mg in Patients Homozygous Sitosterolemia | Lipid Metabolism, Inborn Errors;Heart Disease | Drug: MK0653, ezetimibe;Drug: Comparator: placebo | Organon and Co | NULL | Completed | 18 Years | 85 Years | All | 30 | Phase 3 | United States |
| 8 | NCT00092833 (ClinicalTrials.gov) | July 2002 | 23/9/2004 | Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED) | An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia | Hypercholesterolemia, Familial;Lipid Metabolism, Inborn Errors | Drug: Comparator: ezetimibe | Organon and Co | NULL | Terminated | 8 Years | N/A | All | 49 | Phase 3 | United States |
| 9 | NCT00045812 (ClinicalTrials.gov) | March 2001 | 10/9/2002 | SCH-58235 (Ezetimibe) to Treat Homozygous Sitosterolemia | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate SCH-58235 in Homozygous Sitosterolemia | Lipoidosis | Drug: SCH-58235 | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | N/A | N/A | Both | 5 | Phase 2 | United States |
| 10 | NCT00092807 (ClinicalTrials.gov) | February 12, 2001 | 23/9/2004 | Sitosterolemia Extension Study (0653-003)(COMPLETED) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia - 1 Year Open-Label Extension | Lipid Metabolism, Inborn Errors;Heart Disease | Drug: MK0653, ezetimibe;Drug: Comparator: placebo | Organon and Co | NULL | Completed | 10 Years | N/A | All | 37 | Phase 3 | United States |
| 11 | NCT00092820 (ClinicalTrials.gov) | February 12, 2001 | 23/9/2004 | Sitosterolemia Extension Study (0653-004)(COMPLETED) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia | Lipid Metabolism, Inborn Errors;Heart Disease | Drug: MK0653, ezetimibe;Drug: Comparator: placebo | Organon and Co | NULL | Completed | 10 Years | N/A | All | 58 | Phase 3 | NULL |