Efficacy and Safety Study of Nidadd in the Management of Hyperlipidemia

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Nidadd

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Niacin, Hyperlipidemia

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

Outcomes

Primary Outcome Measures

Change from baseline in HDL-c levels

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00244231

First Posted

October 25, 2005

Last Updated

February 27, 2007

Sponsor

Genovate Biotechnology Co., Ltd.,

1. Study Identification

Unique Protocol Identification Number

NCT00244231

Brief Title

Efficacy and Safety Study of Nidadd in the Management of Hyperlipidemia

Official Title

A Placebo-Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Nidadd in the Management of Hyperlipidemia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Genovate Biotechnology Co., Ltd.,

4. Oversight

Data Monitoring Committee

No

5. Study Description

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 efficacy of escalating doses of extended-release Nidadd in hyperlipidemic patients. The trial begins with measurement of baseline lipid levels. Fasting blood samples will be collected at screening and each treatment visit (except visit 3) for lipid analysis and safety monitoring. Chemistry laboratory tests and hematological testing are performed periodically. Patient's diet education will be given by dieticians or appropriately trained counselors at visit 1 and 2. Patients who are taking any lipid-modifying drugs will be required to go through a 4-week washout / diet-controlled period prior to randomization (visit 2). Treatment duration is 16 weeks in total: Patients randomized to treatment with Nidadd will receive 500 mg for the first 8 weeks of the medication period. For another 8 weeks, the dose is then increased to 1000 mg and is maintained to the end of the study. The patients in control group will take placebo in a same fashion as that of Nidadd group throughout entire 16 weeks. The primary measure of efficacy is the change from baseline in serum HDL-c level. Secondary measures of efficacy are changes from baseline in serum total cholesterol, LDL-c, and triglycerides. Safety and tolerability will be evaluated from adverse events, number of patients who prematurely discontinue the trial because of adverse events, and laboratory measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemia

Keywords

Niacin, Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

70 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nidadd

Primary Outcome Measure Information:

Title

Change from baseline in HDL-c levels

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials: