NCT01942291

Brief Summary

Individuals with reduced plasma concentration of high-density lipoprotein (HDL) cholesterol are more susceptible to oxidative stress and often present reduced endothelial function, which has been mainly related to this susceptibility. Studies in animal and cell models have demonstrated that niacin activates both GPR-109A in leukocytes and heme oxygenase-1 (HO-1) pathway promoting strong anti-inflammatory and anti-oxidative effects. . In this context, the aim of this study was to investigate the short-term effect of niacin on endothelial function and verify the existence of interaction of PGD2 receptor antagonist, i.e. laropiprant (LRPT), in subjects with low HDL-cholesterol (HDL -C).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
Last Updated

September 13, 2013

Status Verified

September 1, 2013

Enrollment Period

9 months

First QC Date

September 10, 2013

Last Update Submit

September 10, 2013

Conditions

Hypoalphalipoproteinemia

Keywords

NiacinEndothelial functionLaropiprantHDL

Outcome Measures

Primary Outcomes (1)

  • The short-term effect of niacin on endothelial function.

    Endothelial-dependent vasodilation was assessed by ischemia-induced reactive hyperemia of the brachial artery by using an ultrasound equipment

    7 days

Secondary Outcomes (2)

  • Plasma C-reactive protein levels

    7 days

  • HDL-C and HDL size

    7 days

Study Arms (2)

Niacin/Laropiprant

EXPERIMENTAL

Extended-release niacin 1g/day associated with Laropiprant 1g/20mg (ERN/LRPT, Cordaptive, Merck, Sao Paulo, Brazil)

Drug: Niacin

Niacin

EXPERIMENTAL

Extended-release niacin 1g/day alone (ERN, Metri, Libbs Farmaceutica, Sao Paulo, Brazil)

Drug: Niacin

Interventions

NiacinDRUG

The study was randomized, double-blind, controlled, using a 2-way crossover design with both treatment periods and washout time lasting 7 days. Subjects were allocated by simple randomization to extended-release niacin 1g/day alone (ERN, Metri, Libbs Farmacêutica, São Paulo, Brazil) or niacin associated with LRPT 1g/20mg (ERN/LRPT, Cordaptive, Merck, São Paulo, Brazil).

Also known as: Nicotinic acid, Vitamin B3
NiacinNiacin/Laropiprant

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • asymptomatic individuals
  • plasma HDL-C levels \<40 mg/dL

You may not qualify if:

  • symptomatic atherosclerotic disease
  • diabetes
  • liver disease
  • renal disease
  • thyroid dysfunction
  • indication for or use of lipid-lowering treatment in the last six months
  • use of anti-inflammatory treatment in the last 30 days
  • current or previous diagnosis of cancer or immune inflammatory diseases
  • chronic obstructive pulmonary disease
  • infectious disease manifested in the last 3 months
  • body mass index ≥ 26 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campinas

Campinas, São Paulo, 13083-887, Brazil

Location

Related Publications (1)

  • Nasser Figueiredo V, Vendrame F, Colontoni BA, Quinaglia T, Roberto Matos-Souza J, Azevedo Moura F, Coelho OR, de Faria EC, Sposito AC. Short-term effects of extended-release niacin with and without the addition of laropiprant on endothelial function in individuals with low HDL-C: a randomized, controlled crossover trial. Clin Ther. 2014 Jun 1;36(6):961-6. doi: 10.1016/j.clinthera.2014.03.012. Epub 2014 Apr 24.

    PMID: 24768191DERIVED

MeSH Terms

Conditions

Hypoalphalipoproteinemias

Interventions

NiacinNiacinamide

Condition Hierarchy (Ancestors)

HypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Andrei C Sposito, PhD

    University of Campinas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

September 13, 2013

Record last verified: 2013-09

Locations

BR(1)