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Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)

NCT02633956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2018-06-04

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Obeticholic Acid

Once a day (QD) by mouth (PO)

DRUG

Atorvastatin

Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO). Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated. Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

DRUG

Placebo

Once a day (QD) by mouth (PO)

Sponsors & Collaborators

  • Intercept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • David Shapiro, MD · Intercept Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-04
Primary Completion
2017-03-21
Completion
2018-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02633956 on ClinicalTrials.gov