Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

January 10, 2012 updated by: GWT-TUD GmbH

Placebokontrollierte Untersuchung Zur Wirkung Von Nikotinsäure Auf Die Dyslipidämie Bei Metabolischem Syndrom Und Das Arterioskleroserisiko (Placebo Controlled Investigation of Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome and the Risk of Atherosclerosis)

Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome. Nicotine acid decreases postprandial hyperlipidaemia in patients with metabolic syndrome which reduces the low-grade inflammation and the risk of atherosclerosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • GWT-TUD GmbH, Centre for Clinical Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • dyslipidemia (triglycerides >= 150 mg/dl and/or decreased levels of HDL-cholesterol <40 mg/dl in men or < 50 mg/dl in women)
  • further components of the metabolic syndrome: Hypertension: blood pressure >= 130/85 mmHg or/and Hyperglycemia: fasting plasma glucose >= 100 mg/dl or/and 2 hour plasma glucose after 75g glucose load (OGTT) >= 140 mg/dl or/and Obesity: waist circumferences > 102 cm in men or >88 cm in women

Exclusion Criteria:

  • Contraindication and incompatibility of nicotine acid
  • Patients with ulcus ventriculi or ulcus duodeni
  • Intake of lipid lowering drugs < 6 weeks before randomization
  • therapy of type 2 diabetes with insulin, glitazones, acarbose or more than one antidiabetic drug (only mono-therapy with metformin or sulfonyl urea is permit) - no acceptable therapy of diabetes with levels of HbA1C>=8.0%
  • cardiovascular events in the last 6 months
  • chronic inflammatory diseases (lupus erythematodes, arthritis, morbus Crohn or colitis ulcerosa)
  • ALAT elevation 2.5 times more than the normal limit
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
Drug: nicotine acid
16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication
Placebo Comparator: 2
16 weeks treatment with placebo
Drug: placebo
16 weeks treatment with placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome
Time Frame: after 16 weeks treatment
after 16 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GWT-TUD GmbH

Collaborators

Technische Universität Dresden
University of Regensburg

Investigators

  • Principal Investigator: Markolf Hanefeld, MD, PhD, GWT-TUD GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 10, 2008

First Submitted That Met QC Criteria

April 10, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIASPAN-DD-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metabolic Syndrome

Clinical Trials on nicotine acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe