Evaluation of ARI-3037MO, to Suppress LDL Cholesterol in Patients With

Status Active, not recruiting

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of ARI-3037MO compared to placebo in reducing low-density lipoprotein cholesterol (LDL-C) levels in subjects with dyslipidemia.

Clinical Trial Description

This study is a prospective, multi-center, randomized, double-blinded, controlled clinical trial. The study will compare two arms: ARI-3037MO 3 g BID vs. placebo.

Subjects who sign informed consent will be enrolled and will undergo all Visit 1 assessments. Following evaluation of Visit 1 laboratory assays, eligible subjects will receive a phone call (Visit 2) during which they will be instructed to begin the lifestyle modification and enter a 4- to 6-week lead-in period (6-week wash-out period for subjects to wash out of non-statin lipid-lowering therapy [subjects may remain on statins during this period], 4 weeks for subjects receiving statins only or not receiving any lipid-lowering therapy), followed by a qualifying fasting LDL-C measurement at Visit 3. After the lead-in period, if the LDL-C level at Visit 3 is not ≥ 100 mg/dL, an additional week will be allowed for another qualifying measurement at a subsequent visit (Visit 3.1). If performed, the LDL-C level at Visit 3.1 must be ≥ 100 mg/dL in order for the subject to continue participation in the study. Qualifying subjects will be randomized in a 1:1 manner at Visit 4 to one of two arms of the double-blind, 24-week efficacy and safety assessment phase. Randomization will be stratified by background statin therapy status at Visit 1 (yes/no). Baseline lipid levels will be defined as lipid levels at Visit 4. End-of-study lipid levels will be defined as the lipid levels at Visit 7 (Week 24).

A final closeout and safety assessment visit will be held at 26 weeks post randomization (Visit 8). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02532218
Study type	Interventional
Source	Arisaph Pharmaceuticals Inc
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	August 2015
Completion date	December 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of ARI-3037MO, to Suppress LDL Cholesterol in Patients With Dyslipidemia — REASCEND

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms