HyperlipidemiaPhase 3NCT00244231
Efficacy and Safety Study of Nidadd in the Management of Hyperlipidemia
A Phase 3 study testing Nidadd in people with Hyperlipidemia, run by Genovate Biotechnology Co., Ltd.,.
Trial summary
To assess the efficacy and safety of Nidadd (extended-release niacin) in patients with hyperlipidemia. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Nidadd
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Aug 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Placebo-Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Nidadd in the Management of Hyperlipidemia
To assess the efficacy and safety of Nidadd (extended-release niacin) in patients with hyperlipidemia.
Read the 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.
- Conditions
- Hyperlipidemia
- Being tested
- Nidadd
- Keywords
- Niacin, Hyperlipidemia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NidaddDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HDL-c levels
Secondary outcomes (1)
Changes from baseline in serum total cholesterol , LDL-c, and triglycerides
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startOct 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jen-Der Lin, M.D., Principal investigator, Chang GungMemorial HospitalJawl-Shan Huang, M.D., Principal investigator, Chang Gung Memorial HospitalMiaw-jene Liou, M.D., Principal investigator, Chang Gung Memorial HospitalChih-ching Wang, M.D., Principal investigator, Chang Gung Memorial HospitalYi-Jen Hung, M.D., Principal investigator, Tri-Service General Hospital (TSGH)Chang-Hsun Hsieh, M.D., Principal investigator, Tri-Service General Hospital (TSGH)Chih-Tsueng He, M.D., Principal investigator, Tri-Service General Hospital (TSGH)Huey-Herng Sheu, M.D., Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244231
- Sponsor's protocol ID
- GBL03-NSR
- Status last verified
- Feb 2007
- First submitted
- 25 Oct 2005
- Last updated
- 1 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Nidadd in the Management of Hyperlipidemia
- ClinicalTrials.gov ID
- NCT00244231
- Acronym / sponsor ID
- GBL03-NSR
- Conditions
- Hyperlipidemia
- Keywords
- Niacin, Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Aug 2005
- First posted
- 26 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nidadd | Drug | – |
Primary outcome
Change from baseline in HDL-c levels
1 secondary outcome
Changes from baseline in serum total cholesterol , LDL-c, and triglycerides
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen-Der Lin, M.D. principal investigator
Chang GungMemorial Hospital
Jawl-Shan Huang, M.D. principal investigator
Chang Gung Memorial Hospital
Miaw-jene Liou, M.D. principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nidadd in people with Hyperlipidemia, run by Genovate Biotechnology Co., Ltd.,.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HDL-c levels. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2007.