Niacin/Laropiprant and Endothelial Function

NCT01126073 | Completed Phase 4 DMC

• 1 other identifier: 127-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Heart Disease

Keywords

niacin/laropiprant; endothelial function

Outcome Measures

Primary Outcomes (1)

• 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

  Ultrasound measurement of endothelial dependent brachial artery dilation before and after treatment will be performed in all patients.

  12 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: Placebo

Niacin/Laropiprant 2000mg/40 mg

ACTIVE COMPARATOR

After two weeks patients, who have already been on a stable dose of a statin for at least 6 weeks, will be randomized in the ratio 1:1 to either receive ER niacin/laropiprant or placebo in addition to the statin therapy. Patients in the ER niacin/laropiprant group will receive 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: Niacin/laropiprant

Interventions

Niacin/laropiprant DRUG

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.

Niacin/Laropiprant 2000mg/40 mg

Placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35-55
• Confirmed CHD (post MI patients, coronarography and/or cycloergometer)
• Already treated for dyslipidemia with a statin and reaching ESC LDL target
• HDL-C \<1.1 mmol/l, TG \> 1,7 mmol/l and LDL \< 2,6 mmol/L
• Will be enrolled into the trial

You may not qualify if:

• x increase of liver enzyme tests or CK
• Severe renal insufficiency - creatinin \>200 mmol/l
• Hypersensitivity to nicotinic acid
• Other cardiac medication stable for at least 4 weeks prior to enrollment
• Acute MI, CABG, PCI within past 3 months
• Congestive heart failure (CHF) \_ NYHA 2
• Ejection fraction \< 40% measured within the past 6 months
• Malignancy
• HIV infection or immunodeficiency state
• Stable dose of statin \< 6 weeks
• Diabetes mellitus type 1
• Diabetes mellitus type 2 with HbA1C \> 7%
• Hypo/hyper thyroidism
• Alcohol or drug abuse

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Niacin; MK-0524

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof. Mirasn Sebestjen Mdf, PhD

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 19, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

SL (1)