Niacin/Laropiprant and Endothelial Function

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 3x increase of liver enzyme tests or CK

• Severe renal insufficiency - creatinin >200 mmol/l

• Acute disease within 6 weeks prior to inclusion

• 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