Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)

A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00376584

Enrollment

825

Registered

2006-09-15

Start date

2006-07-31

Completion date

2007-01-31

Last updated

2017-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesteremia, Hyperlipidemia

Keywords

Primary Hypercholesteremia, Mixed Hyperlipidemia

Brief summary

This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.

Interventions

DRUGMK-0524A

DRUGER Niacin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patient is appropriate candidate for niacin therapy * Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C \<130 mg/dL at V1 * Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C \<130 mg/dL at V1 * Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C \<160 mg/dL at V1 * Patient has TG \<500 mg/dL (5.65 mmol/L) at V1 * A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria * ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA

Exclusion criteria

* Patients with unstable doses of medications * Pregnant or lactating women, or women intending to become pregnant are excluded * Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed * Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)

Design outcomes

Primary

Measure	Time frame
Global Flushing Severity Score (GFSS) during 7 days of treatment	during 7 days of treatment

Secondary

Measure	Time frame
Percentage of Participants Who Experience at Least 1 Adverse Event	up to 10 weeks
Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event	up to 10 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026