A Double Blind, Randomized Study to Compare Influence of Niacin/Laropiprant on Functional and Morphological Characteristics of Arterial Wall and Parameters of Inflammation in Subjects With Coronary Heart Disease Already Treated With a Statin

NCT01126073 Phase 4 COMPLETED

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

Details

Lead sponsor	University Medical Centre Ljubljana
Phase	Phase 4
Status	COMPLETED
Enrolment	60
Start date	2010-09
Completion	2011-10

Conditions

• Coronary Heart Disease

Interventions

• Niacin/laropiprant
• Placebo

Primary outcomes

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

Countries

Slovenia