Clinical Trial Details
| Trial ID: | L0169 |
| Source ID: | NCT02633956 |
| Associated Drug: | Obeticholic Acid |
| Title: | Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL) |
| Acronym: | CONTROL |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT02633956/results |
| Conditions: | Nonalcoholic Steatohepatitis |
| Interventions: | Drug: Obeticholic Acid|Drug: Atorvastatin|Drug: Placebo |
| Outcome Measures: | The Effect of Obeticholic Acid on Low-density Lipoprotein (LDL) Concentration (Least Squares Mean Change From Baseline at Week 16)|The Effect of Obeticholic Acid on LDL Particle Size (Least Squares Mean Change From Baseline at Week 16)|The Effect of Obeticholic Acid on LDL Particle Concentration (Total) (Least Squares Mean Change From Baseline at Week 16) |
| Sponsor/Collaborators: | Intercept Pharmaceuticals |
| Gender: | All |
| Age: | 18 Years to 85 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 84 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | December 4, 2015 |
| Completion Date: | March 12, 2018 |
| Results First Posted: | June 4, 2018 |
| Last Update Posted: | June 4, 2018 |
| Locations: | St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States|Scripps Clinic, La Jolla, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|Nature Coast Clinical Research, Inverness, Florida, United States|University of Miamai, Schiff Center for Liver Diseases, Miami, Florida, United States|South Florida Center of Gastroenterology, Wellington, Florida, United States|Florida Medical Clinic, P.A., Zephyrhills, Florida, United States|The Queen's Medical Center - Liver Center, Honolulu, Hawaii, United States|Mercy Medical Center, Institute for Digestive Health & Liver Disease, Baltimore, Maryland, United States|Kansas City Research Institute, Kansas City, Missouri, United States|St. Louis University, Saint Louis, Missouri, United States|Duke University Medical Center, Durham, North Carolina, United States|Cumberland Research Associates, LLC, Fayetteville, North Carolina, United States|Consultants for Clinical Research, Cincinnati, Ohio, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, United States|University Gastroenterology Liver Center, Providence, Rhode Island, United States|Medical University of South Carolina, Charleston, South Carolina, United States|ClinSearch, Chattanooga, Tennessee, United States|Texas Clinical Research Institute, LLC, Arlington, Texas, United States|Liver Associates of Texas, P.A., Houston, Texas, United States|American Research Corporation at the Texas Liver Institute, San Antonio, Texas, United States|McGuire DVAMC, Richmond, Virginia, United States |
| URL: | https://ClinicalTrials.gov/show/NCT02633956 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D248 | Obeticholic Acid | Chemical drug | DB05990 | NR1H4 activator; NR1H4 agonist; FXR agonist | Enhance lipid metabolism | Approval rejected | Details |
| D020 | Atorvastatin | Chemical drug | DB01076 | DPP4 inhibitor; AHR agonist; HDAC2 inhibitor; NR1I3 ligand | Enhance lipid metabolism | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D349 | Statins | Miscellany | -- | -- | -- | Under clinical trials | Details |