NCT00376584

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
825

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

September 14, 2006

Last Update Submit

February 15, 2017

Conditions

HypercholesteremiaHyperlipidemia

Keywords

Primary HypercholesteremiaMixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Global Flushing Severity Score (GFSS) during 7 days of treatment

    during 7 days of treatment

Secondary Outcomes (2)

  • 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

Study Arms (3)

Placebo → MK-0524A 2g

PLACEBO COMPARATOR

Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by MK-0524A 2 g for the remainder of the study (7 days).

Drug: MK-0524ADrug: Placebo

Placebo → Extended Release (ER)-Niacin 2g

ACTIVE COMPARATOR

Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by ER-Niacin 2g for the remainder of the study (7 days)

Drug: ER NiacinDrug: Placebo

MK-0524A 2g

EXPERIMENTAL

Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A 2g for the remainder of the study (approximately 2 weeks).

Drug: MK-0524A

Interventions

MK-0524ADRUG
MK-0524A 2gPlacebo → MK-0524A 2g
ER NiacinDRUG
Placebo → Extended Release (ER)-Niacin 2g
PlaceboDRUG
Placebo → Extended Release (ER)-Niacin 2gPlacebo → MK-0524A 2g

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypercholesterolemiaHyperlipidemiasHyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemias

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 15, 2006

Study Start

July 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

February 16, 2017

Record last verified: 2017-02