NCT00659321

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

1.7 years

First QC Date

April 10, 2008

Last Update Submit

January 10, 2012

Conditions

Metabolic SyndromeDyslipidaemia

Outcome Measures

Primary Outcomes (1)

  • Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome

    after 16 weeks treatment

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

16 weeks treatment with placebo

Drug: placebo

Interventions

nicotine acidDRUG

16 weeks, randomisation with 500 mg, after 4 weeks elevation of 1000 mg, after week 8 to week 16 1500 mg study medication

1
placeboDRUG

16 weeks treatment with placebo

2

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GWT-TUD GmbH, Centre for Clinical Studies

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Metabolic SyndromeDyslipidemias

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Study Officials

  • Markolf Hanefeld, MD, PhD

    GWT-TUD GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2008

First Posted

April 16, 2008

Study Start

January 1, 2007

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

DE(1)