Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)
Public ClinicalTrials.gov record NCT02633956. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double Blind, Placebo Controlled Clinical Study Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on Lipoprotein Metabolism in Subjects With Nonalcoholic Steatohepatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid, and the subsequent addition of statin therapy, on lipoprotein metabolism in subjects with nonalcoholic steatohepatitis (NASH) with fibrosis stage 1 to 4, but no evidence of hepatic decompensation.
Study identification
- NCT ID
- NCT02633956
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 84 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 4, 2015 (Actual)
- Primary completion
- Mar 21, 2017 (Actual)
- Completion
- Mar 12, 2018 (Actual)
- Last update posted
- Jun 4, 2018
2015 – 2018
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| Scripps Clinic | La Jolla | California | 92037 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| University of Miamai, Schiff Center for Liver Diseases | Miami | Florida | 33136 | — |
| South Florida Center of Gastroenterology | Wellington | Florida | 33414 | — |
| Florida Medical Clinic, P.A. | Zephyrhills | Florida | 33542 | — |
| The Queen's Medical Center - Liver Center | Honolulu | Hawaii | 96813 | — |
| Mercy Medical Center, Institute for Digestive Health & Liver Disease | Baltimore | Maryland | 21202 | — |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | — |
| St. Louis University | St Louis | Missouri | 63104 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45249 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University Gastroenterology Liver Center | Providence | Rhode Island | 02905 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| ClinSearch | Chattanooga | Tennessee | 37421 | — |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | — |
| Liver Associates of Texas, P.A. | Houston | Texas | 77030 | — |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | — |
| McGuire DVAMC | Richmond | Virginia | 23249 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02633956, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2018 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02633956 live on ClinicalTrials.gov.