Trial record 11 of 389 for:    nicotinamide

Niacin/Laropiprant and Endothelial Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miran Sebestjen, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01126073
First received: May 7, 2010
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Coronary Heart Disease
Drug: Niacin/laropiprant
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Ultrasound measurement of endothelial dependent brachial artery dilation before and after treatment will be performed in all patients.


Estimated Enrollment: 60
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126073

Locations
Slovenia
UMC Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
  More Information

No publications provided

Responsible Party: Miran Sebestjen, assist. prof. Mirasn Sebestjen Mdf, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01126073     History of Changes
Other Study ID Numbers: 127-00
Study First Received: May 7, 2010
Last Updated: October 5, 2011
Health Authority: Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
niacin/laropiprant
endothelial function

Additional relevant MeSH terms:
Niacin
Nicotinic Acids
Niacinamide
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014