NCT00244231

Brief Summary

To assess the efficacy and safety of Nidadd (extended-release niacin) in patients with hyperlipidemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2003

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

October 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2005

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

October 25, 2005

Last Update Submit

February 27, 2007

Conditions

Hyperlipidemia

Keywords

NiacinHyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HDL-c levels

Secondary Outcomes (1)

  • Changes from baseline in serum total cholesterol , LDL-c, and triglycerides

Interventions

NidaddDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects between the ages of 20 and 75 years.
  • An at least 4 weeks wash-out / diet-controlled period before study entry is required.
  • HDL cholesterol \< 40 mg/dL for male and \< 50 mg/dL for female; and triglyceride levels ≧ 200 mg/dL.
  • Being mentally competent and able to understand all study requirements and sign the informed consent form.

You may not qualify if:

  • Total cholesterol ≧ 300 mg/dL; triglyceride levels ≧ 1000 mg/dL.
  • Having FPG level greater than 180 mg/dL after a 4-week washout / diet control period.
  • Type-1 diabetes mellitus; or type-2 diabetes mellitus without stable (fixed dose) medication.
  • Pregnant or lactating women or women of childbearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives).
  • Concomitant steroid therapy.
  • Received any lipid-modifying agents within the four weeks of wash-out / diet-controlled period.
  • With clinically significant cardiac arrhythmias or other serious cardiac abnormalities; received coronary artery bypass graft or percutaneous transluminal coronary angioplasty within 6 months prior to study entry.
  • Malignant tumor (except for squamous/basal cell skin cancer), or chronic terminal disease (e.g. AIDS, liver cirrhosis, etc.) within past 5 years.
  • With any disorders or conditions which, in the opinion of the investigator will preclude successful compliant participation in the study.
  • Nephrotic syndrome or any other renal dysfunction, serum creatinine \> 2.0 mg/dl; active hepatic dysfunction, SGPT, SGOT, gGT, or alkaline phosphatase value greater than 2 times the upper limit of normal.
  • With pancreatitis, gallbladder disease, or active peptic ulcer disease within 6 months.
  • Active gouty arthritis.
  • Taken any other investigational drug within one month prior to study entry.
  • With known hypersensitivity to niacin.
  • With a history of alcohol and/or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jen-Der Lin, M.D.

    Chang GungMemorial Hospital

    PRINCIPAL INVESTIGATOR

  • Jawl-Shan Huang, M.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Miaw-jene Liou, M.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Chih-ching Wang, M.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Yi-Jen Hung, M.D.

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

  • Chang-Hsun Hsieh, M.D.

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

  • Chih-Tsueng He, M.D.

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

  • Huey-Herng Sheu, M.D.

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

  • Yu-Ling Lin, M.D.

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

  • Shih-Yi Lin, M.D.

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

  • Yih-Jing Tang, M.D.

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 26, 2005

Study Start

October 1, 2003

Study Completion

August 1, 2005

Last Updated

March 1, 2007

Record last verified: 2007-02