Status:
COMPLETED
Efficacy and Safety Study of Nidadd in the Management of Hyperlipidemia
Lead Sponsor:
Genovate Biotechnology Co., Ltd.,
Conditions:
Hyperlipidemia
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
To assess the efficacy and safety of Nidadd (extended-release niacin) in patients with hyperlipidemia.
Detailed Description
This is a randomized, double-blind, placebo-controlled, and multicenter study. A total of at least 50 patients will be recruited to achieve 40 evaluable patients required to assess the safety and effi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00244231
Start Date
October 1 2003
End Date
August 1 2005
Last Update
March 1 2007
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