Efficacy and Safety Study of Nidadd in the Management of Hyperlipidemia

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genovate Biotechnology Co., Ltd.,

Criteria

Inclusion Criteria:

1. Male and female subjects between the ages of 20 and 75 years.

2. An at least 4 weeks wash-out / diet-controlled period before study entry is required.

3. HDL cholesterol < 40 mg/dL for male and < 50 mg/dL for female; and triglyceride levels ≧ 200 mg/dL.

4. Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion Criteria:

1. Total cholesterol ≧ 300 mg/dL; triglyceride levels ≧ 1000 mg/dL.

2. Having FPG level greater than 180 mg/dL after a 4-week washout / diet control period.

3. Type-1 diabetes mellitus; or type-2 diabetes mellitus without stable (fixed dose) medication.

4. 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).

5. Concomitant steroid therapy.

6. Received any lipid-modifying agents within the four weeks of wash-out / diet-controlled period.

7. 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.

8. Malignant tumor (except for squamous/basal cell skin cancer), or chronic terminal disease (e.g. AIDS, liver cirrhosis, etc.) within past 5 years.

9. With any disorders or conditions which, in the opinion of the investigator will preclude successful compliant participation in the study.

10. 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.

11. With pancreatitis, gallbladder disease, or active peptic ulcer disease within 6 months.

12. Active gouty arthritis.

13. Taken any other investigational drug within one month prior to study entry.

14. With known hypersensitivity to niacin.

15. With a history of alcohol and/or drug abuse.