Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244231
Status:
COMPLETED
Last Update Posted:
2007-03-01
First Post:
2005-10-25
Brief Title:
Efficacy and Safety Study of Nidadd in the Management of Hyperlipidemia
Sponsor:
Genovate Biotechnology Co Ltd
Organization:
Genovate Biotechnology Co Ltd
Study Overview
Official Title:
A Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Nidadd in the Management of Hyperlipidemia
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 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 Patients diet education will be given by dieticians or appropriately trained counselors at visit 1 and 2
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
3 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
4 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
5 Safety and tolerability will be evaluated from adverse events number of patients who prematurely discontinue the trial because of adverse events and laboratory measures
1 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 Patients diet education will be given by dieticians or appropriately trained counselors at visit 1 and 2
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
3 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
4 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
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None