CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 263 enrolled
Drug / intervention
CP105F +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03857256
NCT03857256Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Compare The Efficacy And Safety Of High-Medium Molecular Weight Beta-Glucan As Add-On To Statin Therapy In Subjects With Hyperlipidemia.

Montreal Heart Institute·interventional·Posted Feb 27, 2019·Updated Jan 16, 2024

In Brief

A Phase 2 clinical trial evaluating CP105F and Placebo for Hyperlipidemias. Completed, enrolled 263 participants across 1 site.

Detailed Summary

The objective of this study is to evaluate the effects of adding beta-glucan (1.5 g, 3 g or 6 g daily) administered three times a day (TID) in divided doses, to atorvastatin (10 mg - 20 mg) once a day or an equivalent dose of another statin on heart disease lipid risk factors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemias
CountriesCanada
CollaboratorsCeapro Inc., The Montreal Health Innovations Coordinating Center (MHICC)

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 27, 2019
Enrollment StartMay 31, 2019
Primary CompletionAug 31, 2021
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.3 years ago

Interventions

CP105Fdrug

Natural Health Product

Placebodrug

tablet manufactured to mimic the CP105F beta-glucan