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Niacin/Laropiprant and Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01126073
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : October 6, 2011
Sponsor:
Information provided by (Responsible Party):
Miran Sebestjen, University Medical Centre Ljubljana

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


Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Niacin/laropiprant Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo 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.

Active Comparator: Niacin/Laropiprant 2000mg/40 mg
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
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.




Primary Outcome Measures :
  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 [ Time Frame: 12 weeks ]
    Ultrasound measurement of endothelial dependent brachial artery dilation before and after treatment will be performed in all patients.



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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126073


Locations
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Slovenia
UMC Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
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Responsible Party: Miran Sebestjen, assist. prof. Mirasn Sebestjen Mdf, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01126073    
Other Study ID Numbers: 127-00
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011
Keywords provided by Miran Sebestjen, University Medical Centre Ljubljana:
niacin/laropiprant
endothelial function
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Niacin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs