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Niacin/Laropiprant and Endothelial Function

NCT01126073 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-10-06

No results posted yet for this study

Summary

Primary objective:

To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant (ERN/LRPT) compared to placebo added to statin therapy on endothelial dependant dilatation of the arterial wall assessed by brachial vasoreactivity in stable coronary heart disease (CHD) patients.

Secondary objective:

To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant (ERN/LRPT) compared to placebo added to statin therapy on serum lipids and the parameters of inflammation in stable coronary heart disease (CHD) patients.

CHD-coronary heart disease ER-extended release

Conditions

Interventions

DRUG

Niacin/laropiprant

After two weeks patients, who have already been on a stable dose of a statin for at least 6 weeks, willer receive ER niacin/laropiprant in addition to the statin therapy. Patients will receive ER niacin/laropiprant 1000mg/20 mg tablet for 4 weeks, after that the dose will be increased to 2000mg/40mg tablet. The intention is that all patients receive 2000 mg/40mg dose for the rest of the study period, but should they be intolerant to the higher dose, the maximum tolerated dose will be used.

DRUG

Placebo

After two weeks patients, who have already been on a stable dose of a statin for at least 6 weeks, will receive placebo in addition to the statin therapy. Patients will receive 1 tablet for 4 weeks, after that the dose will be increased to 2 tablets for the rest of the study period.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Slovenia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01126073 on ClinicalTrials.gov