NCT01104519

Brief Summary

A study to evaluate the inter- and intra subject variabilities of flow-mediated dilation (FMD) of brachial artery and nitroglycerin (GTN) induced dilation of brachial artery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1

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

March 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

April 13, 2010

Last Update Submit

July 29, 2015

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • flow-mediated dilation (FMD) of brachial artery

    predose, 4 hours post dose and 24 and hours post dose

  • Nitroglycerin (GTN) induced dilation of brachial artery

    predose, 4 hours post dose and 24 hours post dose

Study Arms (2)

1

EXPERIMENTAL

Niaspan - Placebo

Drug: NiaspanDrug: Comparator: Placebo

2

EXPERIMENTAL

Placebo - Niaspan

Drug: NiaspanDrug: Comparator: Placebo

Interventions

NiaspanDRUG

Oral doses of 2000 mg of Niaspan once daily for 7 days.

12
Comparator: PlaceboDRUG

Oral doses of placebo once daily for 7 days.

12

Eligibility Criteria

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

You may qualify if:

  • Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate methods of contraception throughout the study
  • Subject is in good health (other than history of high cholesterol)
  • Subject is a non-smoker

You may not qualify if:

  • Subject has a history of stroke, seizures or major neurological disorder
  • Subject has a history of cancer
  • Subject is unable to refrain from or anticipates the use any prescription or non-prescription drugs
  • Subjects consumes excessive amounts of alcohol or caffeine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Interventions

Niacin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 15, 2010

Study Start

March 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 30, 2015

Record last verified: 2015-07