Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT03857256
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2019-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.
Sponsor:
Montreal Heart Institute
Organization:
Study Overview
Official Title:
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.
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BetAvena
Brief 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.
Detailed Description:
Male and female subjects ≥ 18 years of age with an elevated LDL-C \> 3.37 mmol/L (130 mg/dL) treated with a stable dose of statin for at least 6 weeks (atorvastatin (10-20mg daily) or equivalent dose of another statin), including subject with previous cardiovascular (CV) events, with partial statin intolerance defined as an inability to tolerate statin therapy in the form and dosages required to achieve treatment goals.
Following signature of informed consent, approximately 264 subjects (66 subjects per beta-glucan treatment group and 22 subjects per matching placebo group) meeting all inclusion criteria and no exclusion criteria will be randomized to receive one of the three doses of beta-glucan (1.5 g, 3 g or 6 g daily) administered TID in divided doses or a matching placebo as an add-on therapy to atorvastatin (10- 20 mg administered once daily) or an equivalent dose of another statin.
The subjects will be assigned to the 3 different doses of beta-glucan or placebo in a tiered fashion as follows:
* The first set of 88 subjects randomized will receive either 1.5 g beta-glucan daily (1 tablet of 500 mg TID) or a matching placebo in a 3:1 ratio,
* The next set of 88 subjects randomized will receive either 3 g of beta-glucan daily (2 tablets of 500 mg TID) or a matching placebo in a 3:1 ratio,
* The last set of 88 subjects randomized will receive either 6 g of beta-glucan daily (4 tablets of 500 mg TID) or a matching placebo in a 3:1 ratio.
During the treatment period, subjects will return to the study site at Visit 3 (Week 6) and at the End of Treatment Visit (Week 12) for laboratory tests and clinical assessments, including Adverse Events (AEs), dietary guidance and study product compliance. At the Safety Follow-up Visit (Week 14), subjects will be contacted via telephone for an assessment of AEs.
Following signature of informed consent, approximately 264 subjects (66 subjects per beta-glucan treatment group and 22 subjects per matching placebo group) meeting all inclusion criteria and no exclusion criteria will be randomized to receive one of the three doses of beta-glucan (1.5 g, 3 g or 6 g daily) administered TID in divided doses or a matching placebo as an add-on therapy to atorvastatin (10- 20 mg administered once daily) or an equivalent dose of another statin.
The subjects will be assigned to the 3 different doses of beta-glucan or placebo in a tiered fashion as follows:
* The first set of 88 subjects randomized will receive either 1.5 g beta-glucan daily (1 tablet of 500 mg TID) or a matching placebo in a 3:1 ratio,
* The next set of 88 subjects randomized will receive either 3 g of beta-glucan daily (2 tablets of 500 mg TID) or a matching placebo in a 3:1 ratio,
* The last set of 88 subjects randomized will receive either 6 g of beta-glucan daily (4 tablets of 500 mg TID) or a matching placebo in a 3:1 ratio.
During the treatment period, subjects will return to the study site at Visit 3 (Week 6) and at the End of Treatment Visit (Week 12) for laboratory tests and clinical assessments, including Adverse Events (AEs), dietary guidance and study product compliance. At the Safety Follow-up Visit (Week 14), subjects will be contacted via telephone for an assessment of AEs.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: